October 16, 1996
DISCUSSION GROUP 3
General Regulatory Issues
Moderator: Dan McKillen
|Michael Altmann, Medical Forum, Inc.|
|Mark Boulding, Fox, Bennett and Turner|
|Thomas Chen, Genetics Institute|
|Jim Czaban, Venable, Baetijer|
|Allen Douma, Health Response Ability System|
|Tim Fallon, MedScape, Inc.|
|Elizabeth Toni Guarino, Drinker, Biddle & Reath|
|Renardo Hicks, Deputy Attorney General. Pennsylvania|
|Janis Kelly, Medical Journalist|
|Michael Manzagol, New Millennium Interactive|
|Thomas Merchant, SmithKline Beecham|
|Phil McKee, National Consumers League|
|Dan Mjolsness, American Medical Association|
|Lee Peeler, FTC|
|Michael Scott, CoMed Communications|
|David Vance, Glaxo Wellcome|
|Mary Wallace, American Society of Health System Pharmacists|
|Steven Zatz, Physicians Online|
|Edward Zimney, Immunex Corporation|
|Bruce Grant, Frontier Media|
|Minnie Baylor-Henry, R.Ph, J.D.|
|Cathy E. Conn|
|Rebecca Devine, Ph.D.|
|Roma J. Egli|
|William C. Keller, D.V.M.|
|William B. Schulz, Esq.|
|Donald J. Vasbinder|
|Judy D. Wilkenfeld, Esq.|
|Ann H. Wion, Esq.|
DISCUSSION GROUP 3
General Regulatory Issues
MR. SCHULTZ: We are going to start Panel 3. The first thing I would like to do is ask the FDA part of the panel to introduce themselves. Why don't we start with Ann Wion.
MS. WION: I am Ann Wion, Deputy Chief Counsel for Program Review in the Office of Chief Counsel.
MR. VASBINDER: I am Don Vasbinder. I am a Consumer Safety Officer in the Office of Regulatory Affairs Office of Enforcement.
MR. TART: I am Byron Tart. I am the Director of the Promotion and Advertising Staff in the Office of Compliance, Center for Devices and Radiological Health.
DR. DEVINE: Becky Devine. I am the Associate Director for Policy for the Center for Biologics Evaluation and Research.
MS. CONN: Cathy Conn, Deputy Director, Division of Case Management, Office of Compliance in CBER.
MS. WILKENFELD: Judy Wilkenfeld, Office of Policy.
DR. KELLER: Bill Keller, Division of Surveillance, Center for Veterinary Medicine.
MS. EGLI: Roma Egli, Office of Compliance, Center for Drugs.
DR. MINNIE BAYLOR-HENRY: Minnie Baylor-Henry, Director, Drug Advertising, Center for Drugs.
MR. SCHULTZ: The basic structure, since I know some of you weren't here this morning, is that there are approximately two 40-minute sessions. In the middle, there will be a period for this FDA panel to ask questions and then there will be a period at the end.
That will be followed by a chance for members of the audience to make statements. The critical component, and I think it worked very well this morning in the last session, is that if everybody who talks can try and keep their statements short whether it is a question or an answer then it will move along much better.
There are obviously a lot of participants but if people could do that, if we can do as well as we did this morning, I think it will be a success.
The moderator of Panel 3 is Dan McKillen. He is the President of Southside Consulting which is a newly formed company specializing in multimedia communications with an emphasis on the healthcare industry's use of the Internet. So I think he is quite qualified to lead a discussion of general regulatory issues.
MR. McKILLEN: Thank you, Bill. Welcome everybody. When I was asked to moderate this group a while back and asked to come down from New York to Maryland, I have to admit one of the first things I did was check the calendar to see if I would miss the Yankees-Baltimore pennant race and I am happy to say that that is not a concern right now.
Because the first two groups have covered some of the ground that we are covering, I thought that we might start off by talking about the designated-hitter rule in the World Series this year. Seriously, this session is about general regulatory issues and, specifically, we are going to talk about things like, is the Internet advertising or is the Internet labeling and the handling of the brief summary to make sure that whether it is the brief summary of prescribing information or the full prescribing information that that is someplace where it can be seen by the user or whether it is on all the promotional pages or just buttons and links.
We are also going to talk about fair balance and how do you accomplish fair balance on the Internet on a promotional site that is regulated by the FDA. Then we are also going to talk about some technical ways to identify exactly who is posting information.
As a way to get started, why don't we start with Michael. If you could just introduce yourself, say who you are and what your affiliation is.
MR. ALTMANN: My name is Mike Altmann. I am President of Medical Forum. We are a healthcare communications company, a division of McCann Healthcare Worldwide located in Parsippany, New Jersey. I am also Adjunct Professor, the Department of Communication Arts at New York Institute of Technology in Old Westbury.
MR. BOULDING: Mark Boulding. I am a partner with the law firm of Fox, Bennett and Turner here in Washington. We specialize in healthcare issues.
MR. CHEN: I am Thomas Chen. I am with Genetics Institute. I am a Senior Products Manager.
MR. CZABAN: Jim Czaban. I am an attorney with Venable, Baetijer, Howard and Civiletti in Washington specializing in FDA regulatory concerns.
DR. DOUMA: I am Allen Douma, Medical Director and CEO of Health Response Ability Systems. We started the health and medical channel on America Online and still run about 70 percent of AOL health and medical area.
MR. FALLON: I am Tim Fallon. I am a Director for Medscape. We are a commercial healthcare website on the Internet.
MS. GUARINO: I am Toni Guarino. I am with the law firm of Drinker, Biddle and Reath here in Washington and my practice encompasses both FDA and advertising FTC types of issues.
MR. HICKS: Renardo Hicks, Pennsylvania Attorney General's Office.
MS. KELLY: I am Janis Kelly. I am a medical journalist.
MR. MANZAGOL: I am Michael Manzagol. I am a principal of New Millennium Interactive, a San Francisco-based web developer. We work with many biotech and healthcare companies.
MR. MERCHANT: I am Tom Merchant. I am senior counsel with SmithKline Beecham Pharmaceuticals in Philadelphia, Pennsylvania.
MR. McKEE: Phil McKee. I am with the National Consumers League here in Washington. I run the National Consumer League's Internet Fraudwatch Project.
MR. MJOLSNESS: Dan Mjolsness, Director of Development, American Medical Association Multimedia Group.
MR. PEELER: I am Lee Peeler from the FTC.
MR. SCOTT: I am Mike Scott. I am President and Creative Director of CoMed Communications which is a healthcare education and information company.
MR. VANCE: Dave Vance, an advertising attorney at Glaxo Wellcome.
MS. WALLACE: I am Mary Wallace. I am an attorney and Director of Government Affairs for the American Society of Health System Pharmacists in Bethesda, Maryland.
MR. ZATZ: Steve Zatz. I am the CEO of Physicians Online which is an Internet and online service for doctors.
MR. ZIMNEY: I am Ed Zimney. I am in Regulatory Affairs with Immunex Corporation in Seattle.
MR. GRANT: I am Bruce Grant. I am Director of Content Development for Frontier Media Group, an interactive and online media producer in the Greater Philadelphia area.
MR. McKILLEN: Bruce, thank you for pinch hitting for Dr. Sidney Wolfe who had to leave. We are well represented by a very good group of what might be doctors, lawyers and industry chiefs.
The definition that I found in some FDA documents of advertising include advertisements published in journals, magazines, other publications, newspapers and advertisements broadcast through media such as radio, television and telephone communications.
The definition of labeling includes brochures, booklets, mailing pieces, detail pieces, file cards, bulletins, house organs, letters, films, slides, et cetera. So where does that leave the Internet? I would suggest that, much as in print, a printed detail aid is labeling and a printed journal ad is advertising.
I guess at issue here is if it is advertising, the brief summary is all that is required and if it is labeling, the full prescribing information is required. Where does that leave us, group? Who has some thoughts on the subject?
DR. DOUMA: I would like to lay a little bit of groundwork. I think that to ask a general question about what we do about the Internet may be misleading in that the Internet is really more like an online technology and that technology can be used in many different ways.
One is used as a media, AOL being a classic example, and one used in a plethora of other ways similar and metaphorically the same as in the print. So I hope that we can look at the online technology/Internet as two different functions and that our rules and regulations for each probably will differ, certainly in the short term and, perhaps, in the long run as well.
MR. FALLON: Dan, one of the observations we made early on in some of the FDA meetings we had in New York related to the fact that the current regulations were governed, to a large extent, by the limitations inherent with print, paper and postage. With the Internet, there are no constraints at all to time, space, capacity whatsoever and you are not really asked or forced to prioritize information anymore.
So the brief-summary concept as a subset of full prescribing information is somewhat of a moot point on the Internet. So our recommendation to commercial sponsors that work with MedScape is, in the absence of a specific guideline to choose a path that is consistent with what governs their approach in other traditional media, but just make sure there is a path to follow.
MR. MERCHANT: I would like to echo those last comments. It seemed appropriate in some instances to classify Internet advertising that you read as similar print advertising and it thereby should qualify for use of the brief summary.
But the expense of printing full prescribing information in a medical journal is one of the reason why our brief-summary concept was adopted. That rationale does not seem to exist by and large on Internet applications. So as long as there is some doubt, I have recommended that the company provide full prescribing information rather than a brief summary.
MS. GUARINO: Certainly that is a point to be made that there is no financial limitation or space limitation. However, I think both FDA and FTC have taken the approach over that years that the regulatory requirements for disclosure of information need to be concerned about what the consumer of the information, whether it is an ordinary member of the public or a physician, is going to do with the information, what they will be able to do with the information.
The approach that was just described may not be effective in terms of communicating to certain groups of people the information that the government has an interest in seeing gets communicated. FDA, for example, is struggling with more versus less information in a number of contexts right now including whether or not the very lengthy health claims required to appear on food labels are effective.
So I think the effectiveness of the communication is another regulatory concern.
MR. McKILLEN: Are you saying that a brief summary by its very nature is briefer, that it might be read and it might be acted upon more often or be communicated better than a full prescribing information?
MS. GUARINO: It certainly may well be. What is appropriate for even a brief summary is under consideration by FDA right now in the context of the direct-to-consumer advertising proceeding. Without getting into points of view on that proceeding, I said in my cover letter to FDA requesting to be on this panel I would hope that FDA will use its analyses and the inputs that were obtained in that proceeding as it addresses this very comparable issue in this proceeding.
MR. ALTMANN: I think it is important to recognize that there are many different audiences that are accessing the Internet for information. Yes, because we don't have the space limitation that we should give the option of going to the full prescribing information which any healthcare professional is trained to understand and give an additional option for patient information that is written in lay language and give the access to both to all the audiences there so that everybody can have full access to information that is understandable to them.
MS. KELLY: I have to say as a journalist I think the argument over full versus brief disclosure is kind of irrelevant. People don't read either of them.
MR. McKILLEN: Well said.
MR. FALLON: But I think the fact that the user unfriendliness of trying to read a seven-point type full package insert can go away, to a large extent, with hypertext and structure and organization of the information and makes it much easier to navigate and point and click and get to a specific point of information a lot quicker and it will, hopefully, increase the use of the information.
MR. McKILLEN: That is a good point. On the Internet, the indications, contraindications, warnings, side effects, can all be in a table-of-contents format that you can get to it and the argument could be, Janis, that the Internet makes the prescribing information much, much more customer friendly and much more easy to read.
Allen, do you have some thoughts on that?
DR. DOUMA: I am working in a medium primarily directed toward consumers although we have a significant health-professional physician contingency. Really, we are not being driven to deliver the kind of information we are talking about nor to deliver, in a readable fashion, by any kind of regulatory constraints.
We are driven to that because every consumer that we work with wants it. Now, they don't always want it in exquisite depth all the time. That is one of the advantages of the Internet is people can return over and over again, download it and read it sometime later.
So the consumer is driving the need to know and, unless we can respond to that consumer by delivering information that they, in fact, can use, I agree with everybody here. It doesn't matter what we put up on the Internet or in print.
MR. MERCHANT: Following up on your comment, I have taken the approach that we cannot make the prescribing information more user friendly because it may destroy the balance in there or focus the reader towards that efficacy information and not provide ready access to the adverse-reaction information that is also available on the insert and should be available all in one package.
MS. KELLY: I understand what you are saying, Tom, but I think we could put it in English. The prose in brief- and full-disclosure statements is turgid beyond believe.
MR. McKILLEN: That is a good point and I believe the FDA is working on some DTC guidelines that we will try not to concentrate on too much in this session but it is a point well taken.
MR. MJOLSNESS: I think the AMA feels that both consumers and healthcare professionals should be fully informed about both conditions and about the medicines available to them. For example, when advertising appears on the AMA website, we have either brief or full disclosure and we prefer that a consumer version accompany the physician prescribing information as well. We have that up there currently.
MR. McKILLEN: What about for those companies that don't have an approved consumer version? Would you default to the physician version?
MR. MJOLSNESS: We have done that but we will also work with them to develop one.
MR. GRANT: I think one of the interesting things about the Internet is what an open market it is and what unexpected competition it gives any information you put up there. We are going to be very interested to see what happens to the prescribing information both in its long and its short forms when it has to compete with other forms of drug information.
What happens when it is as easy to click two links and go over to the U.S. Pharmacopoeia or to go over to some other source where there is an even fuller reporting of adverse reactions and interactions than maybe is required in the labeling.
I think it will be very interesting to see what happens to these forms of communication when they have to compete in this market.
MR. ZIMNEY: At Immunex, we have taken the position that most of the product-specific material that we have put on our website is labeling. We don't have any things that I would consider to be advertisements in the traditional definition by the regulations.
I think there are advertisements on the Internet, but that mostly it is labeling and, for that, we have provided full prescribing information. The way that we have done it is that it is there so that somebody could scroll all the way through it if they wanted to but, at the same time, at the top of the document, we have all the headings hyperlinked so that they could either scroll through it or go to individual sections and go back and forth.
MR. SCOTT: With the clients we have been working with, although none of these have actually gone up yet, we have gone one step further than that which is actually any internal link within the prescribing information referenced from one place to the next is also hyperlinked so that people can go directly between parts of the prescribing information as well.
MR. McKILLEN: So it does sound like it doesn't really make a difference whether it is advertising or labeling from the panel here; put the full PI on there, make it easy to get to, and you are covered. Is that a consensus here?
Would anyone have an argument that says all that should be required is the brief summary and that the prescribing information is offering too much?
MR. CZABAN: With respect to prescription drugs, I would agree that the difference between labeling and advertising is minimal if non-existent on the Internet. But as Lee Peeler mentioned in his remarks, and I think in the prior remarks, FTC regulates OTC drugs.
I think in the years ahead, especially as more prescription to OTC switches occur, there may be instances where the labeling advertising distinction can come into play. A hypothetical that I created for this would be a product called Tagaprox, for example--to make up a meaningless name--where there is a prescription version and an OTC version that are different strengths and have different approved indications.
Since they are marketed by the same company that has a website where there is information about both products, the information about the OTC version would normally be considered advertising in this context whereas the information about the prescription, given the very broad definition, Dan, that you mentioned in the beginning of labeling and advertising, it pretty much covers everything.
So, in that situation, you have questions about if both products are covered on a website, does FTC authority leak over to the prescription information? Does FDA authority leak over to the OTC information? This is an issue that may grow in importance. Are there any comments on that?
MR. HICKS: I think your point is absolutely right. In fact, the thing that occurred to me in this dialogue is that the linchpin, from my perspective, is that the information has to be absolutely accurate and complete enough for people to make an informed decision about whatever it is that you put on the Internet.
You can correct me if I mess this up, Lee, but the standard under the FTC rule is unfair or deceptive acts or practices and that is exactly the same standard in most of the states. The states often go further and talk about specific confusion or misunderstanding that is generated by an advertisement.
So, in a sense, in a real-world sense, this is a distinction without a difference because anything that is not covered by the FDA will be covered by the FTC or one of these state consumer-protection statutes. Then, especially for over-the-counter drugs, you have to be avoiding confusion or misunderstanding so as not to be committing an unfair or deceptive act or practice.
MR. VANCE: We put full prescribing information on and if we have patient information, we will put that on. If we have brochures that are designed by patients that we usually run voluntarily by FDA for voluntary preclearance, we will put those on, also.
But we have taken the position that it is advertising. I think there are some legal reasons for OTCs, possibly food, also, that we would want to look at. But it mostly was from the approach of just it make more sense with the broadcast plus we have been looking for metaphors to follow for examples of how rules are applied how to do what we are doing on the Internet.
We felt things like Lifetime T.V. set a good metaphor for the Internet, at least as to having things that were for positions available to a general public. If people wanted, on Sunday morning, to watch Lifetime T.V. or AMA T.V., they could, but, still, it was clearly intended for doctors and it was regulated that way and that was the right way to go.
We felt, for that reason, that the metaphor of advertising made better sense.
MR. McKILLEN: So you follow the metaphor of advertising but you provide the full prescribing information.
MR. VANCE: We met with FDA and showed them the things we were doing. We said there were certain things that, legally, we wanted to keep the playing field as open as possible. But we may not choose to play on that whole field. We think that a brief summary would suffice but there is no reason to do it.
It is the responsible thing to put full prescribing information on and, hopefully, if you got some patient version, to do that, too. So, yes, I think there may be a minimum legal standard but you always can choose to go better than that. Hopefully, many of us will choose to do a lot of things better than FDA would require.
MR. PEELER: Going back to the question of what you do, it seems to me that another thing that we want to consider is not just what we have done in the past but what we should do in the future. There has been very little, that I have seen, consumer research done on how consumers interact with an interactive environment as opposed to a print environment or t.v. environment.
It just seems to me like this is a very good area for that type of research to be done, to figure out which is going to communicate the best.
DR. DOUMA: Let me follow up on that. I think what you were saying earlier that we really need to listen to the consumers and find out what is best for them--I am not sure that I can ever figure it out on my own because I am not a normal consumer. That is not saying I am abnormal, either.
I think we need to do a lot of online research. I will personally commit. We have 1.4 million visits a month of consumers of a health online area, and I can commit to whomever that we can start doing research a week from now if people are interested.
MR. FALLON: The one distinction I think we should consider thinking about the consumer compared to other traditional media is the concept of self-selection. The consumer is the one working the mouse and clicking the button and making a conscious decision to open up a website and go somewhere.
So that is a radical departure from opening up your mailbox and looking at a magazine and reading it. And that is just something that should weigh in some of the thinking today.
MR. McKILLEN: We have the folks here at FDA taking notes and the minutes will be published in the Federal Register soon, I'm sure. Right now, we all have an opportunity to yell and scream and say, "No, no, no. It should be just the brief summary." It doesn't sound like I am hearing that from anyone.
So should there be some guidance from the FDA that says full prescribing information is a prudent way to go. Everybody agrees that that is livable.
DR. DOUMA: I know I have spoken a lot, but let me jump in there. As long as whatever rules and regulations don't, in fact, get in the way of communication, if full prescribing information, as defined the way it is now in its glorious form, is required to be in the face of everybody before they can read something they can really use, then I am against it.
But having that information available online in a usable form by any consumer, and we can always do that, as an empowerment of them making decisions, that is what we are all about.
MR. CHEN: It is interesting we are beginning to talk about new ways to communicate to the consumer. I think this is what this forum is really about. It is interesting because now we are taking the full prescribing information and we are talking about, like, the AMA bringing it down into terms that the consumer can understand.
The question is does it stop there or does that continue to move on to other types of advertisements, and that is a question for the FDA or for others.
MR. McKEE: I just want to reiterate, it is a very good idea to have the full product information but there also needs to be information right off the bat when the consumer enters that section of the website that has it in laymen's terms, that has it in terms which they can understand.
What we have found on our website for information on fraud is that when an individual comes in, we give them information first in laymen's terms and then provide them with links to go to much more in-depth information which professionals can use.
I think that is a very good formula for use on websites because of the technology. It needs to be there so that someone who needs additional information can get it. But you don't turn off the original consumer that shows up.
MR. CHEN: One of the concerns that I have is that the consumer, as much as they are very educated, does not have the education of a physician or somebody in the medical profession, and can you bring the prescribing information down to a fair, well-balanced product that they will understand without the in-depth medical training that physicians have.
MR. BOULDING: Further, on that point, I don't think we should forget that patients who are looking for information are going to be looking in a variety of places. As someone said earlier, they are motivated patients. There is going to be a lot of information that is not generated by the drug company, so if we just leave the full prescribing information in there, the fact that they do or don't read it given the entire universe that they are exposed to.
MS. WALLACE: I agree very much that the information should be brought down to a level that a patient understands. But I think one obligation that we have that we shouldn't lose sight of is that any of this information that we put on there should recommend that patients consult their health professional on this as an adjunct to the information.
I think that is an important thing that we need to bear in mind.
MR. ZIMNEY: I have a radical kind of idea that I would like to propose for a new kind of labeling that I would call educational labeling. The FDA is very much concerned about, has a lot of concerns about, off-label promotion.
But, at the same time, the FDA has been criticized for restricting information. We are talking here about providing information to people. Over the Internet, we have unprecedented ability to provide some new information. I think there could be something called education labeling which could be submitted to the FDA under Form 2253 after it was put up in which the FDA would be able to control off-label information of the company that was completely balanced.
This is the same type of information that we would send to somebody who called our company. We go to great lengths to make sure that that information is complete, balanced, accurate. I think most of the companies here do that and I think we have an opportunity to create a win-win situation for us both by creating a new thing that I will throw out which is educational labeling.
MR. GRANT: We observe a great deal of effort to reason by analogy in the sort of absence of definitive guidance on these issues. I think that is valuable. But we are struck over and over again by just how different a medium this is. We are not going out and trying to grab people's attention for 30 seconds or trying desperately to get them to read two or three pages in a journal.
Our information is being sought out by people who come onto websites and I think, under conditions like those, a lot of things change. In those circumstances, we say the Web treats purely self-serving information as damage and roots around it.
So I think the demand for consumers for in-depth information is going to be much greater. I think the degree to which we can post what we think of as pure advertising is going to be severely limited if we want it to be used at all.
MR. McKILLEN: Bill, do you want the FDA to chime in now, or do you want to go to Question 2 first?
MR. SCHULTZ: I think it is probably a good time to have the FDA ask some questions. I have one that I would like to ask and it really follows up on the comments of Thomas Chen and Steven Zatz. In the late '70's, the FDA embarked on a program to require patient package inserts on all drugs.
That program would have had the Agency very involved in writing the information that would be given to consumers. That was abandoned in the early '80's, but then, in the mid '80's, a number of drug companies came to the Agency and said they wanted to start doing advertising on television.
They offered, at that time, as a way of achieving fair balance, to provide patient information through patient package inserts. That, then, did not come to fruition and now the patient package insert or Medguide effort is in a much different direction where the information is really being provided by private companies.
The Agency writes guidance and so on but it does not review the information or approve it in any way. Now comes the Internet issue. I think that a lot of the discussion recognizes it is very easy to provide the full information, but it is probably also very useless.
I was very intrigued by this idea of consumer information but I would just be interested in the panel's thoughts about whether the Internet advertising should be--how formally should it be linked to some sort of useful information and what should the FDA's role be in reviewing it, approving it or what should it not be.
MR. SCOTT: I think that raises a number of interesting issues one of which is what is the person doing looking for information at all. My experience from running a website and being involved in several of the different online services is that in very few cases are the people seeking information actually looking for very specific information about specific pharmaceuticals.
99.9 percent of the time, they are looking for information about healthcare. When they are looking for specific information about specific pharmaceuticals, they do actually want the full prescribing information. They may need help understanding it.
I believe that you have to think about the question you are asking in terms of the consumer seeking multiple different views on the use of a particular pharmaceutical and a particular condition. Those will include the views of their physician, the views of other patients who have used those drugs, the views of the pharmaceutical company and maybe second and third opinions on all of those.
The full prescribing information or, indeed, patient prescribing information are just two of those possible options.
MR. McKILLEN: Good point.
MR. GRANT: Again, the Web is a highly efficient market. If industry does not provide this consumer information, someone will, and people will know where to find it. The question is is this going to be produced in a way that gives the Agency some opportunity to have some control over it or are we going to seed this function entirely to outside the industry.
MR. McKILLEN: So who better to provide the information than the manufacturer, itself.
MR. MJOLSNESS: In the AMA effort in putting information online and also through various other media, we are creating conditions and medications which may be linked to those conditions but it has to be fair balance and they should be linkable by a user to that product information.
MR. VANCE: A lot of the patient information issues are liability issues. We all, in the industry, remember Mrs. McDonald, the woman who sued about the FDA-required oral contraceptive warning. She read, and she acknowledged that she read, that she could die. She read, and she acknowledged, that she could have a blood clot that could go to her brain.
She had a stroke. She lived. She sued. She said she was willing to die but she wasn't willing to have a stroke and she didn't understand that a blood clot to the brain was a stroke. And she got a phenomenal amount of money that went through on appeal.
We lose the learned-intermediary defense, potentially, if we give a patient a package insert. So that has been a major issue for industry. We have dealt with that in some ways by trying to give more patient brochures with highlights on what the major side effects are, what the contraindications are.
To physicians, to help them talk to and explain the information to patients, the whole direct-to-consumer movement--and I wish Sid were here to hear this--one of the benefits of direct-to-consumer advertising is to put pressure on companies. They are deciding to do that. They are accepting some liability risk there and many companies are working on getting some patient information.
We have seen products like the smoking-cessation products. With other ones where there are high risk, companies have worked out patient information on the higher risk drugs. They may not cover or translate everything in the package insert, but they put at least some of the riskier things into a more user-friendly type of format.
I guess what Phil was raising; if you actually have a content-specific place where you are going to be having product information, presumably, you have put something in lay language in there for the patient to begin with and that is a fair balance issue. It may not be do you have a lay full disclosure.
MR. FALLON: It kind of raises an issue that I kind of agree with Bruce's point of view that if it is not there, if there is no official repository of information on a drug, then where is the consumer getting the information from.
If you go to a Netsearch or a Yahoo and run a couple of searches and look at the sources for the information that are currently driving the information to consumers, it can almost make an argument that it is more irresponsible not to have an official presence with full disclosure information on the Internet.
MR. McKILLEN: That is a good point. They are going to get it one way or the other. It is just a matter of whether they get it right.
MR. SCHULTZ: Ann Wion has a question.
MS. WION: This is really just a clarifying question. I am hearing that you all agree that the Internet is a special medium, that it has many different potential uses, that you have drawn different conclusions from the current regulations about advertising and labeling, about what kind of information to put on the Internet.
I guess my question is given that you view the Internet as something special that may actually have special value to consumers, healthcare providers and others, do you think that maybe FDA in conjunction with the FTC should develop specific regulations with different requirements that branch out, that take a different approach from the approaches that have been taken in the regulations for the traditional media?
MR. BOULDING: I don't want to speak for everybody involved but I think that one can look at the history of new media, television, the telephone, and look what happens when governments develop special rules. They often seem to be more restrictive than the general rules that existed before. I think television is an excellent example of that.
Although your question implies that the rules might be less restrictive, there is also the risk that they might go the other way. There seems to be an urge to control this new medium.
I hear a lot of anxiety both from panel members and from the FDA about the problems of anonymity and other issues of control. It seems to me that a regulatory agency, FTC or FDA, would naturally want to take the approach of more control. So I think one would have to approach carefully any effort to draft new rules for this new medium just based on the fact that it is a new medium.
MS. GUARINO: Before this panel started, I thought all the issues had been aired earlier. But that doesn't seem to be the way the panel is developing. I think, actually, this morning, the first panel sort of reached a consensus, or at least many people said that the Internet is more like other traditional media than unlike.
And folks have pointed out where the what I consider to be rather minimal unique aspects exist-- including some of the things that Lee just said a few minutes ago and, admittedly, they are there--I think generally the Internet is more like existing media than unlike them, the major difference being that information is now more accessible to more types of people than it was before although, clearly, as people said this morning, consumers could always get information intended exclusively for M.D.s if they went to the public library or--it was just harder to get at.
So there is that analogy. And there are other analogies to other telecommunications media that are broadcast very widely as the Internet is, just slightly different. Somebody pointed out this morning that there is going to be, pretty soon, an interactive aspect and a video aspect to the Internet which will make it look even more like other sorts of telecommunication media.
I think, generally speaking, and others have said it earlier, the regulatory scheme that is in place at FDA and FTC is fundamentally suitable and adequate to address the Internet issues that we are talking about today.
In light of the technological changes that are coming forth, I think concern about the hypertechnical aspects of regulating over the Internet is unwarranted and that there are plenty of precedents if you look at these analogous, although slightly different, forms of disseminating information for guidance on how to address similar issues on the Internet.
FDA is already doing it, sending out warning letters. The FTC, as we just heard, is already enforcing the law on this medium. I don't think vast regulatory changes are in order; perhaps some guidance on the narrow issues.
MR. HICKS: I am not sure that I am a proponent of new regulations in and of themselves, but I think it is vitally important to recognize that there are already several wheels turning and that the FTC wheel, the FDA wheel the state regulatory wheels--symmetry has to occur with respect to them.
I don't think this medium is specifically like any other because a report I read last week said that there are 39 million people with E-mail addresses. There is no other medium that you can put information on to reach that many people.
Because of the peculiarity of this vast medium, I think some care has to be given especially to the symmetry question because a company that has products regulated by the FDA and products regulated by the FTC and puts both of them up on the Internet ought to have similar kind of guidance with respect to the rules of the game, so to speak.
MR. SCOTT: I would agree that I believe that the Internet, or rather the potential future Internet, is like no communications medium we have ever seen before. We haven't even started to imagine what this thing is going to become.
I would beg the FDA to consider that they should enforce the current law with regard to bad use of promotion of products on the Internet just as they would anywhere else but to think very hard about how they are going to foster the development of this child which I believe may provide better healthcare information to the American public than anything we have ever seen before in our lives or in history.
MR. VANCE: I would definitely not assume that there is any consensus on the issue of advertising versus labeling. I would ask all the people on the panel and people in the audience to go back home and talk to colleagues.
I am now a prescription-drug person. I used to do OTCs with Burroughs Wellcome years ago. There were things like free-standing inserts for sudafed. We could put those into every newspaper in the country if we wanted to spend the money and we might well easily get 39 million people who then add on to that. The people would see the shelf talkers. If it was a major campaign in the store, we might well hit virtually every American.
With something as ubiquitous as sudafed for colds, we might probably hit more than 39 million people very often. And that was OTC advertising.
What you have heard is it doesn't matter because we can put a great deal of information on. So the consequences for the full prescribing information don't matter, but I think the issues as to OTC medicines, any company that is tangentially involved in OTC medicines and, possibly, food.
The food folks are here today, but if we are saying it applies for OTC medicine, it might for food. So I think wait and see what comments you get on December 16 on that. I do believe that it is these issues of fair balance and other things. The FDA regulations on advertising work. Most of the rest of the questions this panel has is reasonable prominence questions; what is the reasonable prominence of your link to your product information, what is the reasonable prominence of the fair balance.
It is an issue yes, Internet sites may be different, but you have detailers that are a one-page detailer. You have a four-page detailer ad. You have a 20-page launch detailer that has everything in it. You have monographs.
You sometimes have binders or kits that have the formulary kit in it. It has the scientific monograph. It has a collection of all the articles. It has a patient video. One video is a disease video for patients and all of those. Where do you put fair balance? It depends. It is issue by issue. It is follow the regs.
DR. DOUMA: I think the Internet is very special, and it is very special in very positive ways such that our need to regulate it is probably less. Although it is the wild frontier, I think it is going to be self regulating because of the consumers that are using it.
I think, therefore, that if we have a starting point, certainly the starting point where we are today which allows everybody to begin to use the technology is certainly a critical one. Making any decision that is reasonable is probably as important as just waiting for another few years to decide something.
Also I would like to say what I started off by saying; the Internet, per se, is a technology and part of that technology is a medium. Part of that technology is a hundred other different things. If we are going to be relooking at the Internet, perhaps we don't lump everything into one bucket to decide whether or not we want to make changes down the road.
MR. MANZAGOL: I think that one of the biggest challenges that the FDA faces right now is the fact that the Internet, and this has been touched on in the previous two panels, is going to be very different in six months or twelve months.
The fact is our clients are very hesitant to push the envelope in terms of interactivity, but that is, in fact, where the Internet is going. If you really want to understand the Internet, look at what corporations are doing with their intranets.
I bring up one example, for instance, and that is putting interactive quizzes on a home page. If the wrong diagnosis comes up for a patient, who is liable at that point? Those are the kinds of questions I think we need to ask ourselves.
MR. FALLON: In a word, to your question, no; I don't think there should be more regulations. I think a lot of the energy should move from thinking about new regulations to thinking more about really interpreting and working through disclosure because that is really what we are talking about.
I think it is really kind of difficult in the age of managed care and reform that the average doctor is spending 12 minute with a patient, yet we have expectations of that patient to become a better consumer of healthcare and we are talking about not giving them access to the information that will help them do that.
So I think that there are a lot of forces at work. As people understand the relationship between information and better outcomes leading to reduced healthcare costs, that $100 billion industry called noncompliance will come pecking down.
So I think there are many compelling arguments. Again, I go back to if the FDA or industry does not take an official stance, the Internet is going to move forward regardless. There is going to be information out there as there is today, and we are not even two years old yet.
MR. SCHULTZ: I would like to move on, if we could, because we have got three more people who want to ask questions and then I want to get back to your other topics. I just ask that if we could try and move through these fairly quickly.
MR. TART: As we look at the Internet now and in the future, we also have to consider some of the practices that we have been involved with. Manufacturers certainly have been allowed or FDA has said that manufacturers could provide information to unsolicited requests.
Traditionally, that has been providing journal articles or reprints of journal articles. When you look at the Internet and the Web, which is such a powerful tool, where do you see this information that is on the website falling as to an unsolicited request.
For example, just because I am a consumer or practitioner and make an effort to get into the Web, is that an unsolicited effort on my part? Should you be able to click on information or should you have an interactive site where a practitioner or consumer would have to make a request for specific information and then be shuffled off to that site?
MR. McKILLEN: That is a good question.
MR. CHEN: The idea of having an area where patients or physicians could request information I know poses many questions for companies. Who is going to man the information? Who is going to send it out? You will literally get an explosion of people wanting information that I am not sure whether companies out there are ready to handle that from a manpower standpoint.
But it is an excellent question.
MS. KELLY: I'm glad you asked that question because I have been wrestling with the issue. The scenario is as follows: if I am doing a newsletter that covers the oncology meetings and we put a version of it up on the website that is identical to the print version, if the company salesperson carries in the newsletter, then it is labeling and they have to do the whole nine yards.
But what if they provide information about there being a website address. Is that the same thing? I don't know. My parallel concern is that because it is a lot easier to put things like the full disclosure up on the Web, I deeply hope, as a journalist, that the FDA is not going to take that as a point to extend regulation in the way Mark described and require, for instance, every new report that mentions a drug to be hyperlinked to the full disclosure statement on every drug mentioned, or something along the line of that.
MR. HICKS: I think that the concept of requiring people to affirmatively request information and get it sent to them sort of defeats the general effect of the Internet in and of itself. So I think that that is probably a little bit too far. But the mere clicking on to a page is a very affirmative act and, candidly, you can't even get to the place to click unless you have made some affirmative sort of deductive choices.
But we are getting awfully cozy up here on this panel. On the subject of regulation, because I am a regulator, the one thing that occurred to me is that probably the most fertile area for regulation is enforcement because it is very difficult to figure out who it is that you are dealing with.
Regulation authorizing people to be able to get at that kind of information, I think, is appropriate, not so much in limiting the ability to do what you guys normally do, but enforcement authorities do need additional regulatory juice, so to speak, to be able to deal with this medium.
MR. VANCE: On the question of off-label or on-label questions, drug information, I think everybody is trying to reduce the expenses of drug information and do this flexibly. We are trying, at this point, for on-label questions, the most frequently asked questions, like everybody else, to do FAQs, frequently asked questions, for on-label questions.
We did have an interesting exploration which we have not pursued yet with the AMA. We are the sponsor which is revealed all the time on the AMA AIDS site which is run substantively by the International AIDS Society, U.S. They do the total content independently.
They are very interested in trying to speed the flow of information in AIDS. One of the things that was raised by Dr. Paul Volbering with Glaxo Wellcome was could we take the most commonly asked off-label questions, the ones that we have to answer again and again and again, and could we give them to IAS, let them sanitize them and review them and say, "We understand these are the most frequently asked questions about this product," and put it on the Internet.
We advise that we would not want to do that alone, that we would prefer that they had several companies doing it simultaneously so, again, it would be a balanced, open thing. Then we looked at it and decided that unless we have done other things with independent entities and no matter what the quality of the entity is, sometimes we have disagreed with the medicine.
One situation, if the independent company had put the medicine on, it would have potentially killed respiratory patients and we lost all the money in that investment because it couldn't be changed, we felt. And we decided at this point that since we could not control it, we would probably not go that way although if they wanted to answer the question separately, they could do it; we will still have to answer drug-information questions one by one, and we are looking at having our--our drug-information people are available by E-mail as they are by phone as they are by fax as they are, occasionally, at meetings.
MR. CZABAN: Following up on Renardo's point, the issue of how to enforce and what the regulators can do, they do need more juice, not necessarily in the form of new or different regulations but more funding.
I know that is a problem at the state level and the federal level. I think if there was unlimited funding to enforce the law as it exists now with respect to the Internet, you could go a long way towards ending fraudulent or abusive practices.
At the risk of being accused of suggesting a way to foster more litigation, it may be a legislative approach is more appropriate where a private cause of action could be created so that consumers out there who fall prey to particular scams or have problems related to Internet could bring an action more or less on behalf of the regulators.
MR. SCHULTZ: Why don't you go ahead to your next issue.
MR. McKILLEN: Okay; and we will come back to you at the end. The second issue--the question is, "How should product information, whether it is full prescribing or brief-summary information, be presented to insure that Internet users will know that the product information is available and where it is available."
So now it is not a matter of whether it is brief summary or prescribing information, I think we are all in agreement that the full prescribing information should be communicated. Now the question is how should it be communicated? How do you link it? How do you have it in the face of the user?
DR. DOUMA: You do it so that the user wants to use it, period. But there are many ways to do that. You can do it with buttons. You can do it with menu lists. You can do it with hypertext links from every article that talks about the subject. In fact, if you do use those technologies effectively, they will be a consumer advantage and the consumer will like what you are doing for them.
I don't think here is a situation where, at least in my experience over the last four years, we want to do more linkage rather than less. We don't need to be told by any regulator to do more because our consumers want us to do more. So I don't think it is a particular issue.
How you do it and how you design it is critically important because, like anything else, if you overdo it, they won't come back to your site either. It is a combination of communication. It is not really a technical issue, quite frankly. It is more esthetics and creativity than anything else.
MR. McKILLEN: So then if the suggestion was a button on every page, you suggest that a hyperlink button--that might be overkill. It might not be a good experience for the user?
DR. DOUMA: It may not be, to limit it to that, to say you have got to do it on every page. You could say, perhaps, that there is some link from every article, somehow, and then let somebody design how that link is best carried out. I have got some thoughts on that, but this is certainly not the forum to talk about that.
MR. SCOTT: This is a highly context-related question. It depends on what information is being provided. It depends on how many drugs are being discussed in a particular article. It depends whether it is a site that is specific to a company or whether it is an independent site that might want to be able to link to several different prescribing informations for several different drugs.
But it is really about how people see what is put in front of them, and that is going to depend on what it is. If it is a video, the whole question is very different from if it is a straight text article.
The point was made that this is about creativity and that is exactly right. We will be able, in time, to measure which ones work best.
MR. McKILLEN: That is the beauty of the Internet.
MR. PEELER: I think I would just echo that. It is an issue of creativity. I think if you go out on the Web right now, there are all kinds of disclosures on the Web that are either virtually inaccessible to the consumers that are using those websites or they are presented in such a way that nobody in their right mind would read them.
At the end of almost all these websites, there is a legal page. Very frequently, when we are investigating, the company will say, "Well; it is right there on our legal page," which is at the end of the website. It is just line after line after line of text.
So there really are some challenges in terms of getting the consumer's attention. I think one of the consumer-behavior theories of the Internet is that consumer attention is going to even be more scarce in that environment than it is in traditional media.
MR. McKILLEN: It seems that there is a consensus that we don't need more regulations. But yet the FDA has to struggle with providing guidance to the industry on how this should be handled. The devil may be, indeed, in the details.
MS. GUARINO: My concern is why does the FDA want to know? Why do they want to know the answer to that question? From a regulatory standpoint, I think if the FDA is asking how should the information be presented, the concern is that they want to know because they want to know exactly what should be prescribed.
Again, I think if you go back to some of the points that were made that this is a very changing technology, and that there are lots of different--so that if you promulgate regulations or even guidance that goes to the details applicable to today's technology, they may well be outdated tomorrow.
So I would say, in terms of answering this question, the answer is you look to some of the more general approaches like setting performance standards instead of specific detail standards as in every page or every screen or every whatever needs to have this kind of a link, or whatever.
So, again, recognizing that the technology is changing and that the information is very diverse would say to me it should be provided in a way that, from a regulatory standpoint, FDA needs to be concerned about its usefulness to the intended audience, not the specific details.
MR. McKILLEN: So keep it loose.
MS. GUARINO: Yes.
MR. MERCHANT: I think the standard should be reasonable access. When the site visitor comes in, they should, perhaps, not at every page but reasonably within several pages, depending on the context, again, have access to the full prescribing information either through buttons or hypertext links with whatever is appropriate to the site.
MR. MJOLSNESS: We think that an product information should be directly linked to an ad and ought to be clearly a link. We also, in the educational part of our business, do not, similar to the print publications, want ads directly adjacent to editorial content by linkage or on the virtual page.
We have a couple of ways pragmatically that we handle this. One is to have a click to a non-promotional transitional page, then to product information with a button to return the viewer to the banner, or to go straight to the DPI from the banner and then back to the banner but not back to editorials so we have some control internally of the path.
Finally, we do provide acknowledgment of support at the opening page, the end of the particular document and then on the footer on each screen.
MR. McKILLEN: Do you have anything to add to that, Dave?
MR. VANCE: I suggest to the FDA that we compliment companies that did well, so I thought maybe I would use an example here that is not us but actually Pharmacia Upjohn on their expanded access program for HIV AIDS Prescriptor because I think this is what the real world is by a user-friendly piece.
I picked up this brochure at the AIDS conference. It is a very short brochure but when it goes on the Internet, it is actually multiple pages. But there is an introductory page, a summary of what it is, very easy to read and you can stop there; that is, it is one screen but it is a page/document.
You can't scroll down any further although, depending on the size of your monitor, it might be several screens on your monitor. At the bottom, you can click whether you want to get the expanded-access data or not. It then has a page that splits you off. It is very simple, just, again, probably one screen, as to the United States or other countries where they might have it in the future.
Then you get into the patient program. At the bottom of the page, again, it is one or two screens. At the bottom, you can click for the drug overview, the patient information or physician information.
If you go to the patient information, one of the things they offer you is the side effects. But at each page, there are multiple options of where to do next. There is this continual table of contents and ability to go back and forth between the pieces.
This is a consumer-friendly piece. This is what we are all trying to do. We have pieces with things back and forth, at the top and at the bottom. It is a mission statement of this Web provider. It is their disclaimers. This is the way I think good companies will do it because we want to be consumer friendly.
As I think someone commented, we put the package insert and stuff in there because the consumers want it. If you don't have it, you will lose credibility. You want to have all that stuff. We have got nothing to hide and we want you to see this stuff.
MR. McKILLEN: So your point is if you make an effort to have some prominence in that information, that should suffice and not require any style or every page or every area, just reasonable prominence?
MR. VANCE: The GMP regs were one of the brilliant moves of FDA and, I think, a good model to follow again. The GMP regs are somewhat general. FDA very specifically said, "You have got to address the issue of sanitation in the plant but we are not going to tell you how to do it. As long as you do it in a reasonable way, we will give guidances. We will tell you, 'This worked.' We will send notice-of-violations out and warning letters on what didn't work, but you have got flexibility.
"We want to be creative. We want these plants to keep on getting better and better. You have got to address the issue, but we are not going to tell you precisely how." We have got to have a product-information spot. We have to have fair balance, to compliment people who do it well and zap the people who don't.
MR. GRANT: I think, to our point of view, the important thing is that across the whole range of these issues from disclosure to full-product information to fair balance to information to access, the Web offers a far richer suite of tools for providing this from links to intercept screens that capture your page request, even if you request a page 25 pages deep in your site, and give you some disclosure as you are coming in, even down to the much execrated blink tag.
I think the tools we have to do this are far richer and far more varied than in any other medium and I am hoping that in the period from now in the immediate time future that we can look at these techniques, examine how they are used, give ourselves some chance to make a judgment as to which ones work best, which ones are, in fact, good practices and promote those.
MR. McKILLEN: Thank you. There seems to be a trend particularly among pharmaceutical marketers when they put their websites where, as recently as a year ago, there were annual reports and very little product information and now I see disease-management resources and disease-treatment guidelines and other interactive assets for the user.
Some of the sites I have seen now include what you could arguably say is 85 percent information and 15 percent promotion. That is probably a good thing to get people to come back to your site. But then the question that we have to answer here in 2(b) is, "Does it matter where the product information is located on the website and, if so, where should it be located?"
DR. DOUMA: I would just like to say I think (b) and (a) are essentially the same thing, technically. It doesn't matter where it is. It matters how you link to it and how prominent and compelling your experience is that gets you the links. So I am not sure that it is any different question.
MR. McKILLEN: The point I am highlighting here is that maybe much of the information on a company's website is not promotional information, it is informational. It might be tips on jogging. It might be how to exercise, how to lose weight. The company may manufacture an analgesic. Then, in that, do you need to have a link to your product promotion on the information pages or should that link be prominent throughout.
MR. FALLON: I think that relates, again, to the context issue. If you are talking about a nutrition and exercise website and it is more of a branding initiative by a company because they want to be identified with promoting nutrition and exercise and whatever, they are not really selling anything.
I don't know if that begs the need. Obviously, there are regulatory folks who look at it but if there are no claims being made, if there are no real offering being made, there is no discussion of disease or use of drugs, in that context, I don't really see a compelling need to have a product-information availability there.
MR. SCOTT: I would concur with that. The important issue here is that you do have links to appropriate prescribing information from product claims. If there is no product claim, why do you need any form of link at all. If there is a product claim, you must, according to current regulation, give some sort of full prescribing information, some sort of prescribing information.
I think that is the end of it.
MR. McKILLEN: Sounds reasonable.
MR. ZIMNEY: I would agree with that. I think maybe where the FDA is going with this is that if the entire website might be considered labeling, if any part of the website is labeling, and I would disagree with that. I would disagree with that.
The Internet is discretely parceled. You go to different parts of this, just like we have things that are labeling, we have things that are advertising. There is information on the website that is not labeling and the areas that are should be linked to the full disclosure.
MR. MERCHANT: I would just like to make the technical point that the product information, while it should be available, does not have, in my view, to be on the website, itself. For instance, we might have a product website on a server in New York that links to prescribing information on a website in France.
I think that is important in reviewing the site structure from the FDA's perspective that as long as the information is readily available, it is not crucial that it be on the same server.
MR. McKILLEN: So where it links to doesn't matter as long as you hit the button and you get the information you want, in English, of course.
MR. MERCHANT: That's right.
DR. DOUMA: Let me ask the question, do you think there is any difference if you are going to a Glaxo website which is a company website that has got content and information versus going to a Compuserve, an AOL, medium in which there is information created by the medium in which advertising is positioned.
Are we seeing these questions as different questions or are we bundling them together?
MR. McKILLEN: I think you pose a good observation there. Many times, the information a company puts up--they take responsibility for what they put up on their website but I don't think they would take responsibility for anything the America Online decides to put up or, for that matter, any other website puts up about their products.
There is only so much responsibility a company has, but let's find out from Tom.
MR. MERCHANT: I kind of bundle them altogether. One possibility, for instance, would be for a drug company to sponsor a section on healthcare within America Online. And, to the extent that refers to the company's drug product, the prescribing information should be available.
To continue my analogy, it doesn't mean the prescribing information has to be on America Online's server. It can be on the company's own server.
MR. SCOTT: From the point of view of some of the independent providers of information, ideally, we would like to be able, as often as possible, to link to a company website or a company organized website of some description so that we have no responsibility for the changes in prescribing information that happened.
The company already has that responsibility. Ideally, by linking in that way, we can get to the latest prescribing information and not something that was four years out of date that nobody bothered to change.
MR. McKILLEN: And they are tough to change.
MR. ALTMANN: To go back to the question literally where does it matter where the product information--I think Allen said it earlier that the consumer is going to drive where we are going to put the information. If it is not in an easily accessible position, then the consumer is not going to go back there anymore.
That is really what is going to drive it. If it is at the beginning of the page, the middle of the page, the end of the page or on every page, the consumer is going to let us know where they want it. If we don't put it where they want it, they will tell us by not revisiting the sites.
MR. McKILLEN: So, to summarize, then, in areas where you are not being promotional or you are not promoting your products, having a hot-linked button to the product information probably is not necessary according to our panel here. But in areas of your website where you are promoting products, just like the brief-summary buttons that we talked about earlier, there should be some reasonable prominence to get to that information.
Whether or not that information is on a server at SmithKline or in France or in America Online, as long as you can hit the button and get the information, that should suffice.
Good. We have a great panel that is reaching consensus on all items so far.
The third question that we have for the panel is, "How should information about a company's regulated products be presented on the Internet to insure that the user has access to a balanced presentation of both side effects and contraindications and information relating to the effectiveness of the product? Should the balance be considered in the presentation of the information on every screen, in every advertisement, or on the entire website?"
I think the meaning behind this question is what if you have a 16-page product promotional ad and, perhaps, the first eight screens might be product-promotional information and the next eight screens might be contraindications, side effects, warnings, balance information, what kind of prominence do you have or guarantee that the user will scroll through the first eight pages to get to the next eight pages?
That is one analysis of the question.
MR. CHEN: I don't think you ever have any guarantee that that is going to happen, that the last eight pages will be read. I think what we do traditionally, today, when anybody hands out any clinical information, a visual, there is full prescribing information given with all those items.
So that is the only way that you can insure that the full fair balance information is provided to physicians or to the consumer who picks that up.
MR. McKILLEN: This is not a prescribing-information issue, per se. This is more of a fair-balance issue where how can we guarantee--for example, would you recommend that on every other screen of a product-promotional announcement that one screen is product attributes and another is contraindications or warnings or side effects, brief summary or prescribing information aside, the fair balance of the communication, itself.
MR. CHEN: I think today, and correct me if I am wrong, if a representative goes and talks about a clinical study that is specific to a product, they are not always giving the fair balance. They are not talking about all the side effects in many cases. What they do leave is full prescribing information which has the information which will give a fair balance statement of the product.
I don't know if I stand corrected or not.
MR. SCHULTZ: I also want to ask--we have got just slightly under ten minutes, if we could just be sure we get to Question 4. However you want to do it, but I just wanted to ask you.
MR. McKILLEN: We will try and get through this quick.
MR. MERCHANT: Generally, we have not relied on prescribing information to provide fair balance to print ads or to promotional context. I think the current FDA regulations and guidance on print ads--with regard to print ads and the manner in which fair balance should be provided provide good guidance for Internet applications.
I don't think it is appropriate to have fair-balance information on every screen. But every other screen in many contexts may be appropriate.
MR. VANCE: Again, to be user-friendly, if it is going to be 36 pages or multiple pages, most things have a table of contents up front and they prominently list the side effects because that is what the consumer expects to see if you are talking about your drug.
If you don't, you don't look credible and the consumer is not going to stay there, ten to one, because every other good company is going to have that prominently up front in their table of contents. You get there, you look and see what the things are.
MS. KELLY: I agree with Dave on that because the fact is I don't know anybody except regulatory-affairs people inside companies who start at the beginning of a disclosure statement and read to the end and then stop. I think the only thing that makes any sense is to put something, buttons, up at the top or a menu or something so people can go to what they are interested in. That's what they do now.
DR. DOUMA: I want to build on what David said, in particular. I think the good companies are going to do two things. One is they are going to market information available through hypertext, through menu, through whatever this technology can offer, and it is a lot.
But, in addition to that, what we are going to see is more and more companies--not just the media that I represent--are going to realize that it is extraordinarily important to get people to be motivated and empowered to want that information in the first place.
It is to the benefit of the drug companies to have everybody know what the side effects are before they take their drugs. We can all work together in enforcing that through our creativity.
MR. GRANT: The real issue, obviously, is reasonable prominence. Anybody who has been through the exercise of getting a detail aid or any other tactic like this approved knows that what you balance and how you balance it is going to vary depending upon what the claims are, what you are talking about at the moment.
Here, again, I think the technology gives us more tools to do that rather than just cram a screen full of one or two bullet points and the rest of the screen is fair-balance language. I think there is really the possibility to develop a whole lexicography of ways of linking out to very specific balance to very specific points whether that is icons, whether it is text links, whether it is, in some cases, balance that is so important that it needs to be directly on that screen, itself.
I think we have got many more hours in our quiver here than in other media.
MR. McKILLEN: Let's get onto the last question, Question 4, which says, "From a technical point of view, what are the ways of identifying the responsible person who posts information on the Internet?"
Phil, just like we practiced--Phil has a good point of view on this that I want him to share with the group.
MR. McKEE: There are several ways in which an individual can find out the identity of whoever is visiting their website or posting to a news group or has sent them E-mail. Each of them is slightly different and all of them can be foiled.
If you have your own website, you can glean the information about the visitor from the information that their browser is broadcasting as well as through the use of certain aplets. If you are looking at what has been posted to a news group, the information which is being broadcast by the individual may not necessarily be their true identity, but by checking the pathways through which that information is gotten to the news server, you can sometimes decide who is the individual that has been posting.
If you are talking about an E-mail message, you can use the full header information and check out the pathways as well. Once you have it back to an account, if you want to find out specific information, you can always use the name servers if that original computer has those set up.
If not, you are stuck with just the name of an account. No matter what, once you have traced it back, you are still back to the point of this is simply the name of an account. You are not guaranteed that you are dealing with the person who owns that account.
Let's say some information has been posted to a news group. It claims to be from an FDA official. It looks all nice and neat. How do you know that that isn't a posting from a janitor at the FDA who has simply gone up to a computer that was left turned on and logged in?
You can never be absolutely certain that the name of the person that is associated with that account is the actual account. Then there are also means on the Internet using anonymous servers, the anonymizer, specifically, to visit a site and to mask the information from a website
Now that the anonymous remailer has been shut down in Finland, that is less of a worry for news groups, but in regards to visiting websites, you can still manage certain anonymity.
MR. McKILLEN: There was some understand before about using what is referred to as water marks or wallpaper. Some companies are, indeed, going to that format so that the background of their webpages all has their watermark or their company name whether it is Pepsi Cola or Kraft.
Phil, if I could just impose upon you to tell the whitehouse.gov versus whitehouse.net story, I think that will shed some light on it.
MR. McKEE: There was a humorous incident a few months ago which many in the press probably remember as well as many others in this room in which two individuals decided to play a little bit of a practical joke and registered with Internet, the whitehouse.net domain name and then promptly set up a spoof website based upon the White House website borrowing graphics from the White House site which could, if you wanted to, make it appear that it was definitely the White House site.
They did leave enough indications that it was not so that people could realize it was a joke. Primarily, instead of placing the pictures of President Clinton and Vice President Gore, they put pictures of Beavis and Butthead.
But the technology is there to capture graphics, to capture background graphics, and then to place them in the background of another site so that instead of having ADF Company, to use the example from the earlier discussion groups--instead of having their watermark on their site with their reliable information, a consumer might be looking at a site which has that graphic pasted in the background looking like the proper watermark, and what they have actually seen is a stolen graphic that has gotten through security which had been placed on someone else's site.
MR. McKILLEN: So it is not always what it appears to be.
MR. BOULDING: I would just like to make the point here that I get the sense that when I hear these stories and any other funny stories that they give the people who are charged with enforcing the laws a bad feeling. I get the sense that people are sitting here thinking about this anonymity and thinking it is bad, we ought to stop it, there ought to be no anonymity.
I would like to present the countervailing point of view. I think that the Internet, in part, was founded upon a culture of being able to be anonymous. There are important reasons why you might expect individuals to be able to present information anonymously.
In fact, the Supreme Court recently held that there was a right to anonymous political speech in a case in Ohio. So there are arguments in favor of being anonymous and it is not necessarily a blanket solution nor may it even be constitutionally permissible to prohibit that kind of anonymity.
MR. McKILLEN: We have time for a couple more.
MR. ZIMNEY: My understanding of this question is that if I, as Immunex--if we put a website called wwwimmunex.com, it is obvious who we are. But if we were to put up a website called wwwofflabel.com and put information there that we would like, if the FDA is wondering is there a way to figure out who is offlabel.com.
I don't know the ultimate answer, but my web people say it is doable, extremely difficult and probably requires a subpoena at a minimum.
MR. SCHULTZ: That settles that.
MR. PEELER: I think that is exactly the point. The people that we in the States are dealing with--this whole problem of finding out who is actually posting this ad is a problem. I think if you are selling people things and taking their money on the Internet that there isn't any right of anonymity.
It has been an issue for enforcement agencies. Enforcement agencies have developed some techniques I don't want to go into right now of how to do that and we would be happy to talk to the FDA about it. But I guess for anybody out there in the room that is really interested in it, we have been able to find everybody.
MR. HICKS: Last comment from Renardo and then we will take it to the FDA and the audience.
MR. HICKS: In fact, I want you to know the FTC taught us how to do it.
MR. PEELER: This made the whole day worthwhile.
MR. HICKS: this question really does raise what I think is sort of the flip side of it as a boiling time bomb in that actual anonymity is a misnomer on the Internet because every time someone clicks onto someone else's webpage, there is a fair amount of information that is immediately transferrable about that person who is clicking on.
They call it clickscreen data. When you click onto someone's webpage, you can discern who their Internet service provider is, whatever the provider is, itself. You can discern approximately where they are geographically. You can discern the type of computer that they are using, the type of operating system that they are using and the type or version of web-browser that they are using as well.
This is information that can be collected by the person who owns the webpage. The question that regulators have to give some thought to is what can people do with that information. Is it permissible for them to do something with that information?
I think that is an appropriate area for regulation to at least be considered.
MR. McKILLEN: Thank you.
MR. SCHULTZ: We have, I think, a couple of FDA questions that I want to run through and then get to the audience statements. The first one is Minnie Baylor-Henry who is Director of our Division on Drug Marketing and Advertising.
DR. BAYLOR-HENRY: My question is specifically for Dave Vance. You suggested at Glaxo that you view the Internet as advertising, and the example that you used to reach that conclusion was actually a broadcast advertising example. At Glaxo, how do you deal with the provision in the regulation for a major statement?
MR. VANCE: I guess we deal with that by considering that part of our fair balance.
DR. BAYLOR-HENRY: Could you elaborate? Are you putting fair-balance statements on every page?
MR. VANCE: As we do for any promotional piece, it depends on the promotional piece. If it is a one-page detailer, or if it is a one- or two-screen piece, it would have to have fair balance on that page. If it is an eight-page detailer and it turns out that we have an index and it is a 16-screen piece on the Internet, we might have a safety subsection where all those things would be taken care of.
There might be a description, pharmacokinetics, description of clinical-trial efficacy and a safety section and a how-supplied section. But we basically, I think, would handle it the same kind of way we would with a print; what does it look like. Everything we review in product reviews, we get asked for screen printouts of how it might look on some monitors because, obviously, it depends on how you format it.
But that is how we review it for prominence and try to have some idea--but, again, we really have no idea what it is going to look like on a particular person's screen because they have got some control over that themselves. But it is that regulatory judgment.
MR. ZIMNEY: I think that the wording of the major-statement requirement is what proves that it is not broadcast advertising because it requires that the major statement be in the audio and/or the audio and the video. Most of these things don't have either audio or video.
So I disagree that it is advertising and I particularly disagree that it would be broadcast advertising.
DR. BAYLOR-HENRY: I wasn't suggesting that it was broadcast or not broadcast. The model that Dave used to describe at Glaxo why they were calling it advertising--
MR. ZIMNEY: No; I am disagreeing with Glaxo's position.
MR. SCHULTZ: Roma Egli has a question. She is a Compliance Officer in the Division of Labeling in Non-Prescription Drug Compliance.
MS. EGLI: Because it is non-prescription drug compliance, it has a different approach to that question of advertising versus labeling. Lee, in his intro speech, and several times during this meeting, people have referred to FTC does this and FDA does this.
In the case of over-the-counter drugs, FDA regulates the labeling. That becomes very important when you classify an Internet information as advertising versus labeling. It would make a difference in an OTC product on whether FTC would be regulating that product or whether FDA would.
We work together very closely and exchange information, but with one exception, the group appeared to say that this was labeling, the Internet information about drug products. I am referring to over-the-counter drug products. I would just like to know if the panel agrees with that.
MS. GUARINO: If I may be so bold. The other 19 people up here may disagree, but I don't think the panel agreed that as far as prescription drugs and restricted devices, which is what this event is about, that communications on the Internet are necessarily FDA labeling. I certainly don't contend that that is the case.
In fact, I'm glad I have the floor because I thought there was something said over here that indicated that because material was print as opposed to broadcast radio or television that that somehow made a difference as to whether or not it was advertising or labeling and that somehow, because information on the Internet is essentially print, it is labeling not advertising.
That, of course, is not a distinction that has ever been made by either agency and shouldn't apply.
MS. EGLI: No; the distinction I was referring to was OTC versus prescription, only with the OTC references.
MS. GUARINO: I am talking not for a particular client by from my own regulatory perspective, I don't think whether the information is about an OTC drug which we are not discussing today or about prescription drugs and restricted medical devices makes any difference whatsoever.
I think, as Glaxo does, that the analogy of most information in the Internet is closer to advertising than it is to labeling. There may be some exceptions. For example, if some product information is intentionally directed to a sales force or something--rather retailers and put out by a sales force, maybe that would be an exception.
But for the most part, I think the advertising analogy is far more appropriate. I don't think there is a consensus that the folks on this panel believe otherwise.
MR. McKILLEN: I would say, based on the comments made today, we pretty much dismissed the issue of whether it was advertising or labeling but did agree that the full prescribing information was not very painful to put up there so why not.
MS. EGLI: You don't need full prescribing for OTCs. That was part of it. And the OTCs that I am seeing are saying, "Send your money in and get this product back."
DR. DOUMA: Just, I guess, to beat a dead horse, but I think it is important to look at the online technology in different ways. I am representing more the media, I suppose, in that I am in a broadcast media. It happens to be a different broadcast than video or audio. We see whatever we do is the media and it is, therefore, advertising in the sense of placing ads. And those ads are backed up from information.
We also, and that is why it gets fuzzy, build online areas for corporations, whether they are medical product manufacturing or otherwise that create an online area and an online experience which we are viewing as an extension of the ad.
The whole thing, therefore, what we were doing is advertising whether it is OTC or otherwise. And that is our very strong position, particularly with OTC.
MR. CZABAN: The labeling advertising distinction for OTCs, and I think you need to look at the statutory definition of labeling, includes a requirement that the information accompany the product. Now, FDA has a regulation that I read only to apply to prescription drugs, 21 CFR 202.1(l)(1), that I thought would have resolved the question of whether the Internet was advertising prescription drugs because it says advertising for prescription drugs includes information transmitted by telephone communication systems.
Currently, the Internet is a telephone communication system, at least the physical architecture of how the information is transmitted is done that way. It doesn't necessarily have to be--it could be done by radio transmission, et cetera, in the future.
But if that doesn't answer the question, maybe there needs to be more discussion.
MR. BOULDING: I think it is a very interesting question. I am not sure that we have fully grasped its ramifications. There are a lot of companies, I think, that would prefer to be regulated by the FTC in their advertising. One would suspect them to take I guess a reductionist approach and argue that, therefore, it is advertising.
But I suspect that if you look at the fundamental statutory authority, I actually disagree. I think that the labeling authority generally seems to have a broader brush application and might be favored in this case.
Although there isn't any really satisfactory or helpful definition of advertising anywhere in the statute or the regulations, one thing you commonly hear tossed around is that it is a commercial communication placed in a third-party medium.
If that is the working definition you take, then you see both advertising and labeling on the Internet. Advertising, much like traditional advertising, can appear on somebody else's site. But in terms of the ramifications of OTC versus prescription, I am not sure that there was any consensus on the panel. I would be surprised if there were.
MR. McKILLEN: If there are not any other questions, let's have people come up to the microphones that have questions. I would ask that you state loudly your name and your affiliation and your question so that everyone can hear.
MR. KUROMIYA: Kiyoshi Kuromiya, Critical Path AIDS Project. I would like to address my question to Renardo. It relates not to anonymity but to privacy issues. Recently, we saw in Florida the possible breach of confidentiality of a database of HIV-positive individuals.
In Pennsylvania, you have Act 148, the law HIV-confidentiality law. I am wondering if this is in force on the Internet and if you are aware of any instances of it being implemented.
MR. HICKS: Realizing you are from Philadelphia, I will be very, very careful. As a practical matter, there has been no enforcement of any of these privacy laws by most of the states. It is obviously a medium where those same privacy protections that currently exist ought to be applied.
One of our difficulties, however, is, as I said several times, coordination and cooperation between the states and between the various federal agencies. I think your apparent assumption is correct that the same privacy protections that a person has with respect to other media ought to be applied to the Internet.
We have yet to see a case, though, that does that.
MS. CLARKE: Jori Clark from SpectraCom, a web development company. One thing I would like to bring out is we do research with a lot of people as to how they use the Internet. One of the things we are constantly surprised on is the wide spectrum of knowledge and how to actually use the technology.
That ranges from everybody from one extreme of people knowing how to do very sophisticated searches to find information they need to other people who don't even know that when they move their cursor over an item and it becomes a hand that that means there is information underneath for them.
So one of the things that I would like to suggest is that as an industry we move towards some symbols that are easily recognizable and people can be trained so that, as they go from one medical website to the other, they will know how to find the information rather than having to figure out how to use the technology in order to come to the information.
The other thing I would like to point out is that this medium is unlike any other, as several have mentioned already, in that we need to think beyond a print kind of format and begin to realize that there are interesting ways to draw the users into information that they need to know, not just what they would like to know.
Being in this industry, we always liken it to being a lumberjack on a log going down the river. Not only do you have to be nimble on your feet to stay on top of the doggone thing but you never know what is around the corner.
We would like to suggest that there are some technologies right around the corner that should make this easier both in database web publishing and also in the ability to not only have to teach people to click but also to stream information to them so that they can learn about what they need to know, not just what they would like to know.
MR. McKILLEN: Well said. Thank you.
MR. WEINBERG: I am Dennis Weinberg. I am a Communications Director with Pfizer Hospital Products Group. I would like to start with a brief disclosure. The following information is offered as a suggestion and it may not necessarily be followed.
I think the FDA has a tremendous task in front of them and I am hoping that with a couple of suggestions here maybe it could be unburdened somewhat.
Number one, I think it would be erroneous to fall into the trap of thinking that there is an analogy in existence for the Internet. There is none. There are pieces. It is a like a magazine except to place and ad you have to pay money to run the ad and that is not the case with the Internet.
What I envision is, if I had to create an analogy, it would be a huge library. However, there are no authors and you have some merchants roaming around hawking their wares. Because of that, I think if you look at existing regs, you may be able to find precedence in a lot of places and, instead of reinventing the wheel, you might be able to tweak some language and cover just a few instances that reveal this to be somewhat different.
The second point, and please take this as a constructive comment, I think the issue of direct-to-consumer advertising and promotion got covered here. The brief versus full disclosure, I don't really think there is an Internet issue.
I think when the direct-to-consumer promotion regulations are established, I think an analogy will exist. You have got so many variables and if you are dealing with those, too, and no constant, you are going to have a tough equation to solve.
The third point, if I can read my handwriting, is that the presentation of information should be left to the communications people who, obviously, are in touch with regulatory and legal groups in their organizations and it is more a matter of style than not, again, an Internet regulation issue.
MR. ROBINSON: My name is Jim Robinson. I am from a company named Avicena in Boston, Massachusetts. We host a medical-information site for healthcare professionals and build internets. I have some advice, I think, for the FDA. My tax dollars are paying for part of this meeting so I thought I would be a little bit more generous with my advice.
My advice is, before you do anything regulatory-wise or guideline-wise is you do take a lead from the FTC and understand the technology a little bit more. A lot of the questions that you are asking today are already solvable. And we are not talking about understanding the technology when interactive video is available but understanding the technology today which actually would allow for the safe presentation of a lot of the information now within the guidelines you set now.
My sense is if you do take the time to understand what can be done, maybe hire an outside consultant or someone like that to walk you through how things work today, you might find that you can focus a lot more on what should be done rather than what can be done.
MR. McKILLEN: Well said. Thanks, Jim.
MR. McCORMICK: Hi. I'm Doug McCormick. I am an outside consultant currently working with--
MR. McKILLEN: Timing is everything, Doug.
MR. McCORMICK: --SmithKline Beecham on their website. I wanted to confirm something I was having trouble hearing. The discussion of finding the proprietors of offlabel.com, was the consensus that that was going to be difficult or hard?
MR. McCORMICK: Because we have had no problem locating the owners, the addresses and the IP addresses of offending domains whose domain names were trademark products of ours. There has been no difficulty finding those people at all.
MR. McKILLEN: I think Phil can shed some more light on that.
MR. McKEE: If you have a full domain name, once you simply go into the Internet IC database, it is quite easy to determine who has made the registration of that name and who has accepted liability for the product which is hawked on there.
MR. McCORMICK: That has been our experience.
MR. McKEE: That is quite easy. It becomes slightly more difficult when you are not dealing with a virtual-domain name but simply a subsection of another website which has been rented out. It is there that greater difficulty could definitely take place.
MR. McCORMICK: Okay. Thanks.
MR. MULLER: My name is Mike Muller. I am an attorney with Eli Lilly and Company and U.S. affiliate. I would like to emphasize and urge the FDA to consider seriously several comments that were made earlier and then touched upon again in this panel, and that is that not everything that is place on the Internet is promotional under the company's websites.
This parcelling of information on the Internet is something the FDA must consider in great detail as to how they are going to determine how to regulate. I think it is imperative that they provide the flexibility to companies to provide information in a non-promotional way as well as information in a promotional way.
I think what was raised earlier about the fact that the FDA, perhaps, didn't see a real big difference between the Internet and currently available media--and I am not sure that is correct partly because I think the biggest distinction is that Internet combines all of these media into one place to receive information.
It could be a depository for public pronouncements to the market. It could be a depository for press releases. It could be a place for promotional material. It could be a place for financial information to the investment community and to investors.
All of these things are now in one place instead of being in separate parcels as they were available before. That is how we need to determine how to regulate it.
I would just ask us to consider that and also to consider some of the things that we didn't touch upon in this panel from a regulatory, promotional standpoint, such as continuing medical education programs, how we are going to treat those on the Internet, how we are going to treat medical-letter requests and information from both medical professionals and from the general public that come in through the website and, perhaps, most importantly, how we are going to deal with timing of relevant information such as things in press releases or information, financial pronouncements.
Is there going to be a timing limitation as to how long those things can stay on the website. There are many, many details I could go much further into, but I think that the FDA really needs to consider and give us specific guidance on those types of issues.
MR. McKILLEN: Thank you.
MR. COMCOWICH: I am Bill Comcowich from Medicine Online. I would like to make two points. Within the context of this discussion, the Internet represents a merger of two major communications vehicles; publishing industry-- and we are all kind of understanding and we focussed, really, on the publishing aspects of this--and the communications or person-to-person communications.
You have regulations that affect both of those already in place and they work quite well. What was misunderstood, I think, in the context here is that overlap between personal communication and publishing that exists in the Internet and in no other media. In every other media, it is separated.
In the Internet, the discussion group overlaps in which personal communications become a publication in which you can publish your personal information to many people. A lot of what was said about discussion groups, I thought was kind of misunderstood.
Discussion groups do something for society that no other media can do. They provide peer-to-peer consultation like no other media can, whether it is patient peer-to-peer for patient support groups or professional peer-to-peer in which you can have access to people you would never have access to at the moment that you need that information.
It serves a very, very valuable function and it should not be regulated out of a new industry. It is extraordinarily important and I think a lot of people misunderstood what the discussion groups were doing.
They are working spectacularly well. Patients are talking to patients. Informed patients are helping each other and professionals kind of monitor it including some professionals in this room like Dr. Grebenau who will occasionally provide the information that helps the discussion alone from a professional point of view.
It is a very important part of the aspect of the Internet. I kind of get the feeling that the FDA asked for this meeting because they are being pushed by some companies to give them a prescription for how to use the Internet. The companies want the prescription because they are too timid to do anything without a prescription.
Well, in this industry, the timid get trampled. The FDA should not write regulations simply to protect the timid. I think the point of one of the attorneys on this panel was very well taken, that you really need to write regulations in the very narrow areas that are not yet covered. Those areas are extremely narrow points of regulation.
Other than that, you do not need to protect timid companies.
MR. McKILLEN: Thanks, Bill. Allen, we have a closing comment from you?
DR. DOUMA: I really want to greatly expand, not in time but in importance, what that gentleman just said. The interactivity of the online world is the incredible power that it provides. We run 500 self-help support groups every month. We get almost a half million messages from consumers every month communicating to other consumers.
What is important is for everybody to be able to say this, perhaps, is like a media talk show. It happens to be a much better talk show. If we are looking at regulating, let's say to the people who are interested in sponsoring this that they are not responsible for the information that is contained in that live interactive or message-board interactive experiences because, if you make someone else responsible for what a third party is saying that is anonymous, you will never get support for this medium at all.
MR. ALTMANN: At the risk of throwing a virtual hand grenade in the middle of the floor, I would like to take a little bit of a liberty with our general discussion group which is general regulatory issues. There were two things that were touched upon very, very lightly today and I think, not to make more work for FDA but it is something you really need to consider, an that is this whole idea of whoever is running that website has access to the information of the person who is accessing it.
We talked about confidentiality. I guess the chipheads call it a cookie which is a bit of information that is immediately transmitted as someone accesses it. Now there are cookie blocks which people would have to put into their computers so it is something you have to look at.
The other issue which was just touched upon very briefly is the promotion of websites, themselves. For example, a biopharmaceutical sales representative who walks into an office with his laptop, opens it up, hooks the doctor online and says, "Let's explore this patient-advocacy group," because he knows they are talking about off-label indications.
He is not, himself, doing it but he is promotion access to something that does talk off-label. These are issues that do have to be addressed.
MR. MJOLSNESS: Just one last comment. Someone was mentioning that there should be some training for people who use the Internet. We launched what we call the PAI Project, which is an acronym for physicians accessing the Internet, last June. We have trained several hundred physicians already on how to use the Internet to be better practitioners.
Secondly, internally, we develop standards for CME and for multimedia development. If anyone is interested in those, not that I am recommending them for the industry but for internal use, for guidelines, you are welcome to contact me about those.
MR. McKILLEN: Thank you.
MR. SCHULTZ: Let me wrap it up. I know it has been a long day. I have got an announcement, an apology, a disclaimer and a thank you. The announcement is that Group 5 has been requested to meet by this screen at 8:15 tomorrow morning. The session will then start at 8:30.
I want to apologize for the temperature in this room. It is the only room I have ever been in that was too cold in the front and too hot in the back. But I want to particularly apologize to the people in the back. We are going to try and get the hotel to fix this tomorrow. At least maybe it can be too cold in the back and too hot in the front.
Third, just a disclaimer. Nobody should take the questions, either the written questions or the questions that the Agency asked or anything that we said, as an indication of our level of knowledge about this, of where we are going about it.
Our goal here was to make a record and to get as much information as we could to make decisions. There is obviously a huge area of this that FDA has no business in. But it also, clearly, crosses areas that are very much our business. It is true that companies that we regulate have, I think, very reasonably said we would like some guidance, we need to know what the rules are.
That leads to the thank you. I want to thank Dan and this panel and really everybody who has participated today. I don't know that I have ever been in a day of a hearing of this type that was as useful or as informative as this one has been.
We got a terrific amount of information out. I think we got some very good suggestions. So I think we should give this panel a hand, but I just want to thank everybody who participated.
[Whereupon, at 5:30 p.m., the proceedings were recessed to be resumed at 8:30 a.m., Thursday, October 17, 1996.]