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FDA and the Internet: Advertising and Promotion of Medical Products - Discussion Group 5



VOLUME I:Remarks   WWW 101  Group 1Group 2  Presentations  Group 3
VOLUME II:RemarksGroup 4  Presentations  Group 5


October 17, 1996


International Issues

Moderator: J. Idanpaan-Heikkila, M.D.



Cedric Allenou, Embassy of France
Jeffrey Blander, SSI Health Systems
Jack Calfee, American Enterprise Institute
Michael Evers, National Health Care
Lawrence Ganslaw, American College of Cardiology
Elizabeth Toni Guarino, Drinker, Biddle & Reath
Robert Klepinski, Medtronic, Inc.
Douglas McCormick, SmithKline Beecham
John Rothschild, Federal Trade Commission
Heather Simmonds, Prescription Medical Code of Practice Authority
Henk Van Der Berg, Net Result/Eurotransplant**?
Minnie Baylor-Henry, R. Ph., J.D.
Ilisa Bernstein, Pharm.D., J.D.
Rebecca Devine, Ph.D.
Roma J. Egli
William C. Keller, D.V.M.
Melissa M. Moncavage, M.P.H.
Stuart L. Nightingale, M.D.
Toni M. Stifano
Byron Tart


A F T E R N O O N    S E S S I O N

[1:00 p.m.]


Discussion Group 5

International Issues

DR. NIGHTINGALE: Our next discussion session is going to be chaired by Dr. Heikkila whom you have already been introduced to. I am going to turn this over to him but, before doing that, why don't we just start with the FDA panel introducing themselves starting with Dr. Tart.

DR. TART: Byron Tart. I am the Director of the Promotion and Advertising Policy Staff in the Center for Devices and Radiological Health.

MS. MONCAVAGE: Melissa Moncavage, Public Health Advisor in the Division of Drug Marketing and Advertising in the Center for Drugs.

DR. KELLER: Bill Keller in the Division of Surveillance, Center for Veterinary Medicine.

MS. EGLI: Roma Egli, Center for Drugs.

DR. DEVINE: Becky Devine. I am Associate Director for Policy for the Center for Biologics Evaluation and Research.

DR. BAYLOR-HENRY: Minnie Baylor-Henry, Director, Drug Advertising, Center for Drugs.

DR. BERNSTEIN: Ilisa Bernstein, Senior Science Policy Advisor in the Office of Policy in the Commissioner's Office.

DR. NIGHTINGALE: Stuart Nightingale, Office of Health Affairs.

DR. HEIKKILA: Thank you for your introduction. I think we should now ask the discussion group to introduce themselves. Perhaps we will use the same philosophy as this morning. You indicate your name, where are you working and, perhaps, why you are here.

MR. BLANDER: My name is Jeffrey Blander and I work with SSI Health Systems as an Associate Director for Development of Clinical Research Products. I am here I guess in the flavor of the meeting. I wear two types of turbans, I would say. The first is from the business and technology side, what can be done and then, from the side of the consumer, what should be done.

I hope to learn from the audience and also other members of the panel. Thank you.

MR. EVERS: I am Michael Evers, lawyer by training. I am also Webmaster of the Natural Health Village. We produce a newsletter called Natural Health Line. We are not primarily focussed on the pharmaceutical or device industry but we are concerned about any regulations on speech that might ultimately affect our products.

MR. GANSLAW: Lawrence Ganslaw, American College of Cardiology. The ACC has members worldwide and are real interested in how to exactly deliver education to cardiologists both within and outside the United States within the law.

MR. GROSSMAN: Good afternoon. My name is Todd Grossman. I am National Market Management for Pharmaceuticals at PR Newswire. We disseminate press releases for the vast majority of pharmaceutical companies. I am here to learn and to also help contribute.

MS. GUARINO: I am Toni Guarino. I am with the law firm of Drinker, Biddle and Reath here in Washington. We are a Philadelphia-based law firm. I am here because of my long-standing interest and practice in both what I would consider traditional FDA law as well as advertising regulation.

MR. KLEPINSKI: I am Bob Klepinski. I am from Medtronic. We are the world's largest manufacturer of implantable medical devices. We are a transnational company and people are using the Net right now to try to find out about us. We have to have a way to deal with citizens of all countries of the world in the Worldwide Net, now, and I am here to learn about it.

MR. McCORMICK: I am Doug McCormick. I am a consultant, an independent consultant, working with SmithKline Beecham on putting together the Health Information Section of their Website. I am here because I am a science journalist with about 15 years of experience working in international scientific issues and because one of the other scheduled panelists did not show up.

MR. MILLER: I am David Miller. I work at Glaxo Wellcome in the Public Policy shop. I am here because we have been dealing, both as a U.S. company but, also, with our U.K. parent company, as to the appropriate use of the Internet and World Wide Web.

MR. ROTHSCHILD: I am John Rothschild. I am a lawyer at the Federal Trade Committee and the Bureau of Consumer Protection and I am here because I have a particular focus on international consumer-protection issues and on the Internet.

MS. SIMMONDS: Hello. I am Heather Simmonds. I am from the Code of Practice Authority in the U.K. and I am here to give a U.K. input to the discussion and to hopefully learn something for our guidance back in the U.K..

MR. VAN DER BERG: My name is Hank Van Der Berg. I am coming from Holland. We are advisors to a non-commercial organization called Eurotransplant, and we are trying to advise them about how to go about having a site on the Internet without hurting their sponsors.

DR. HEIKKILA: Thank you so much for that. Let me first outline how we are going to work. We have three points to be discussed. I hope we can discuss Question No. 1 in quite a short period of time. Maybe we will use some 15 minutes for that.

Then we will move on to No. 2 and No. 3. We will discuss them separately so that we first take Question No. 2. We have first some 25 minutes for group discussion and then we turn to FDA. Then there will be a chance for the audience to ask something.

Then we will move to Point No. 3 and we will do the same. So, if you agree, we will have this kind of an arrangement.

I think we should try to be economic, timewise, and start from the issues. I would move now to the very first question which is very technical in nature. You all have it but I may read it. "What is the state of technology today with respect to identifying who is logging onto your website? What is the state of technology with respect to controlling who is logging onto your website and what information they view on your website? Where do you see the technology going in the future, or some directions that it could go?"

I tried to have volunteers for this point because it is quite technical. I succeeded in having three volunteers. I would ask first Michael Evers to address this point.

MR. EVERS: I think the question of identifying who is logging on the website was handled, maybe indirectly, this morning, talking in the links, so I don't want to dwell on that. A website can stop someone from coming in simply by having registration or subscriptions or whatever, not a particularly attractive feature if your website is really aimed at generating a lot of traffic and getting a lot of people to come to it.

I have been online for about 15 years and for three of those on the Internet. From the very beginning, as we moved out of the academic realm into the commercial realm, there was this concern about people having to identify themselves or give too much information to a website before they could interact with any of the material.

I don't think that has changed that much. I think the marketers are seeking that additional information but I sense that there is still quite a bit of resistance on the part of the average consumer, whether it is an AIDS patient or whether it is a medical doctor exploring alternative therapies or whoever.

As for the question of where the technology is going, I think probably the most interesting or intriguing thing is the use of special agents, agents that can be programmed to retrieve specific information for you, go out every night and look over the entire Internet and if anything new comes in on your subject area, it will be in your E-mail box the next morning and tell you, "This came in. Why don't you go visit it at the website or whatever?"

So we will not have to see that much interaction on the user's part. The user can program this agent to go out and retrieve the information for them.

DR. HEIKKILA: Thank you. John Rothschild?

MR. ROTHSCHILD: Based on some hasty research I did last night, I can report that it is feasible currently to control access to your website depending on the country in which the access is located. That is based on the fact that Netscape is now doing that.

I will give a little background. Federal law places controls on the export of munitions. The U.S. government has defined certain types of encryption software to be a munition and, therefore, subject to these regulations.

Netscape's browser, and certain flavors of it, contains this class of strong encryption, 128-bit encryption. It is, therefore, regulated as a munition. This created a problem for Netscape because it likes to distribute its software via its website. You can go to its website and you can download the browser software, but it had been unable to make its strong encryption software available on the Internet because it couldn't control its distribution outside of the U.S.

But recently they instituted a new system in which, if you want to download that software, you are invited to fill out a form, an electronic form, saying who you are and where you live and certifying that you are a U.S. resident.

The software then, through a means that I don't understand, does a verification of some sort. It doesn't just take your word for it. It performs a verification and if it finds that you are, indeed, located in the U.S., it will let you download the software. It does it based on information that Netscape has on its website. It does it based on the domain name that you are coming in from.

I don't know any more of the technical details, but I do know that according to our technical people at the FTC, any domain names that are located outside the U.S. almost invariably have a two-letter suffix indicating the country in which the domain is located so that if it is located in Canada, the domain name will end in "ca" and so forth for other countries.

That is done by convention. There is no rule that requires it but I am told it is done almost invariably. That is consistent with what I can see that Netscape is doing, that that would provide them a way of verifying the country of location from the domain name.

MR. KLEPINSKI: I don't understand this entirely but I was told that if you went through a service such as Compuserve, there would not be such a country-domain designator on it. Does anybody know that?

MR. VAN DER BERG: Actually, that is correct. From Europe, you can, for example, have ".com" behind your name so that would not identify you as a Dutch company.

MR. McCORMICK: I think that the issue has been pretty well covered except for two areas. One of them is that there are a number of private domains that span national borders. If someone is coming out through that connection, it will be very difficult to tell where they are coming from.

If it is an international domain registered as a U.S. domain, then they will show as U.S. If it is an international domain registered elsewhere, they will show as coming from whatever country they are registered in.

An experience I had a little while ago was sitting in my office in Philadelphia and being turned for a subscription by The New York Times because they couldn't verify that I was coming from the United States.

The other issue that adds onto the agent issue and it is a class of restriction to at least portions of one's own website through profiling internally, getting an idea of what a user's interests are and using database publishing methods which our experience has been that they are unreliable right now to present information in an order that best mirrors the user's interest.

Now, this easily grows into limited restriction guiding physicians into physician-appropriate materials, lay people into more lay-level materials. But that is, to my mind, anyway, technology that we are eagerly awaiting.

DR. HEIKKILA: Does anyone else in the group want to have the floor? Can I turn to the FDA panel and ask if you would like to know something more from the group. If not, then I think we can leave this topic.

MR. MILLER: Just one comment. I know that we talked about this, and the question is directed towards state of technology as far as identification of people. It is interesting, the softer side of that or the actual functional side--a colleague of mine in the U.K. let me know about, if you will, a seal-of-approval site that a vendor is talking about, and they have principles that they want health-related sites to adhere to.

One of those principles is around confidentiality of data including their identity and noting that that would be respected by this website.

So while I think we do have to think about what we technically can do. Especially when we start talking about medical and health information, we have to think about what we can and should do as far as identity of the individual as well as the geographical origin.

Again, as people have noted, there is a very reasonable chance that a person can hide or anonymize their actual geographic origin.

DR. HEIKKILA: Thank you for this comment.

MR. EVERS: I am not sure what would prevent a foreign interest from taking out a U.S. account, downloading the Netscape software and then transmitting it out of the country.

MR. ROTHSCHILD: For that matter, you could walk into any store, and Comp U.S.A in the United States, and buy a copy of Netscape with a strong encryption. That really goes to the State Department policy on exports which a lot of people don't think make sense.

MR. GROSSMAN: Let me first just start out by saying that the ease on the Internet is just going to grow. As we all have our televisions and the ability to cruise through the Web that way, it is going to be very popular.

What also is happening internationally, I think the traffic is going to increase because it is cheaper than long-distance phone calls and you can get in touch with a company when they are closed.

The question I have is that the SEC has certain disclosure requirements that they recognize and certain things that public companies can do to meet disclosure requirements. Will the FDA have international websites or domestic websites that they will recognize as a place where they can put information and have available for pharmaceutical company?

DR. HEIKKILA: Could we have someone to respond from FDA?

DR. BERNSTEIN: I guess I really don't have an answer to that right now but what we are here today for is to address some of these issues and hear what your thoughts are on some of these issues. Sorry; can't respond right now.

DR. HEIKKILA: Can we now move on? I think it is time for that. We will now start discussing more regulatory type issues. I will read the background for the two topics.

"ADF is a multinational company that has a clinical research and development program and currently markets human and animal drugs, biologics and medical devices. ADF realizes that currently promotion materials posted in other countries are just as accessible by Internet users in the U.S. as promotional materials posted inside of the U.S. and that the location of a fileserver does not affect which user has access to the information or how the user accesses it.

"They also know that U.S. federal law and regulation prohibit the promotion of human and animal drugs, biologics and medical devices for unapproved uses or investigational uses. Given the above, the ADF Internet team is trying to decide whether to have one central server and, if so, what country to place it in or whether to have individual servers placed in each country with information specific to residents of that country."

Then we move to the very first question on this area and that is, "ADF is still deciding whether to have one central server or several individual servers. Join ADF in their discussion on how they can promote their products on the Internet without violating the Food, Drug and Cosmetic Act.

"As a start, here are some factors that they are discussing; indicators of intended audience--disclaimers, language, passwords; regulations in other countries; location of the fileserver, how the information is presented--e.g., subdivisions within the website for each country.

"Discuss these and add any other factors that would be appropriate."

So this is the first problem to deal with. Ladies first.

MS. GUARINO: Thank you. This is Toni Guarino. In my introductory remarks, I actually failed to tell you that I am a Vice Chairman of a committee of the International Bar Association that covers product liability, advertising, consumer affairs and unfair competition. There is going to be a meeting on consumer issues and cyberspace next week of the IBA in Berlin, and I promise to bring back information.

But on these issues, I think my take on issues like where the server is located, my learning, actually, from the last two days, is that that is less significant, perhaps, then the disclosures that one makes and the content of the information.

However, it just occurred to me, really, that the international issues here should probably be analogized to however various jurisdictions, the U.S. and outside the U.S., are analyzing the programming and advertising that comes in via televisions, via satellite.

Clearly, there are television programs and advertising that are accessible throughout the world that originate in the U.S. and are subject to U.S. laws and the same for other countries. So I would cite that in the way we have been trying to look for analogous situations in other media.

But, again, my take is that the location of the server is less important than, perhaps, the disclosures and other sorts of information about intended audience.

MR. BLANDER: I would like to confirm the location of the server certainly is not an issue. It is more of a business issue in terms of are we willing to support more than one type of machinery for an international effort to promote certain types of products.

The argument, or I would say the recommendation here, would be to have one central server but, most likely, have at least one backup. But, again, those are really business issues. The heart of the business issue here is the information.

Again, some of my colleagues brought up some excellent and salient points of delivery and disclosure of information. Those are really the more salient points here of is the information that is available on the webpages confirmed and is it validated through scientific rigor.

I think that, based upon any sort of references and any sort of seal of approval which was mentioned, I think these are really the issues that can be looked at in terms of what is available in terms of information on the server, not the technologies that are available in terms of how many hardware types of pieces that you may have or the other types of things that come out, cookies and other things such as that.

MR. KLEPINSKI: I also don't believe we should get hung up on the location of the server. But I do think we have to think about two different classes of information. You talked about fair balance and truth in the information that is delivered to the viewer, the reader, on the Internet. That class of information, whether government restrictions in the U.S. or any other country requiring a specific disclosure, requiring specific things in the labeling, requiring truth, requiring fair balance; all those can be managed on the Internet no matter where the server is.

We can find a way to make sure that we are complying with the laws of each country. There is another class of information that is going to be a little more difficult and that is what I refer to as sort of band information; that is, the information on the specification, for example, on a new medical device that is under clinical investigation.

This is precisely the type of information some consumer patients would like to know. If they are going to get an implant that is going to last five to ten years, they might want to know if they should get it this week or next week when the new version is out.

If they say, "What is out next week?" and you say, "I'm sorry; I can't tell you," it is a frustration for consumers today. That information that is banned that we decided that is not fit for American consumers to see yet is a much more difficult situation.

We have been sort of dancing around trying to squeeze that information out to keep it from--and little bits of it pop out. The Internet is going to explode that because there are going to be reference to clinical papers that are easier to find. People are going to learn more about the things that we previously tried to hide from the American public.

Dr. Temple asked this morning--he said, "We aren't going to review laws." But he said, "Do any of these changes affect our policies?" In that second class of information, the things we don't want people to see at all, that may be getting so small compared to the whole bulk of information on the Internet that banning that from U.S. view may be possible for us and we can comply with those rules and you can keep the present rules, but pretty soon we are going to look pretty foolish because it is going to be such a minuscule amount compared to what is on the Net.

So we need a way for now, at a minimum, to make that accessible to all the rest of our customers in countries around the world where the devices are released, countries where it is clinical but they don't keep the information from the citizens while at least labeling in some way that is not supposed to be accessible here.

So I urge you to find a way that doesn't prohibit free interchange in the rest of the world on that type of information that you don't want American consumer to see.

MR. McCORMICK: I would like to get in a plea for clarity on defining the audience explicitly on the page, the geographical audience U.S. only or U.K. only or some other geographic area, the demographic area for healthcare professionals only, for financial analysts only, for general consumers and the intended purpose to be very explicit, to disclose those.

I think a number of pharmaceutical companies, and I would be happy to be told I'm wrong, have opted, when they have been specific about healthcare information, have almost uniformly chosen first to go to a disclaimer that this is intended only for audiences in the United States and thereby, in their eyes, to limit their liability throughout the rest of the world.

On my own part, I am a little concerned by the unclarity, since you might have to consider anything available on the World Wide Web as direct-to-consumer, and direct-to-consumer is not legal outside the U.S.

In some cases, you may find that complying with rules in one country may put you possibly, or theoretically, in violation of the rules of another country and that is a very difficult situation to find yourself in.

MR. GANSLAW: I would like to echo the comment that I think that audience directors, if you will, things that tell an audience if you are this type of person, you can go here and you cannot go here, are a good way to at least give people an initial indication of where they should go.

But, of course, just as the 15-year-old kid who is trying to see pornography, all you have to do is click through. It is not necessarily going to stop anybody from going anywhere they really want to go.

However, I think there is a huge concern and danger with certain proliferation of password systems. Exactly what that password system would be or exactly what that question would be as that initial hurdle to get, let's say, only doctors into a particular area, only U.S. citizens into a particular area--

MR. McCORMICK: I'm working on that.

MR. GANSLAW: Already you see that people don't like filling out forms. I think that was the heyday of about two years ago on the Internet that every page had a form you had to fill out so that they could collect marketing information about you and then, hopefully, you would give them that password you originally gave them six months ago the next time you got in or maybe the next day.

But I think that if every page requires just a variety of password system, that is an infeasible situation. I think that people get so frustrated they won't use the medium.

MR. KLEPINSKI: I fully agree on passwords. We had intended to use passwords in a certain number of limited situations where you have a very tight, small audience such as the investigators within one particular investigation. There may be ways where the Internet could be confidential enough to have them share information in a password system on a particular site. But, beyond that, it would be just too frustrating to use.

MR. ROTHSCHILD: I would like to suggest another analogy which may be useful for analyzing this situation and it was one that was referred to before. JAMA is available in every public library in the United States and around the world. It contains information that if directed specifically to consumers would violate both U.S. law and, apparently, the law of every other country which doesn't allow any sort of direct promotion to consumers.

Yet we don't ban that journal or any other from the libraries. Neither do we nor do other countries around the world because we make a decision that although it is available to consumers anywhere, it is not targeted to them. Some rule of reason is applied to what types of presentation of information run afoul of those rules.

I think the same sort of analysis should be applied to something appearing on a website rather than just leading to the conclusion that it can't be there because it can be viewed by consumers and that is not allowed.

There ought to be some combination of disclosures and safeguards that satisfy regulators in various countries around the world without preventing the material from being made available.

DR. HEIKKILA: As John Rothschild mentioned, JAMA is freely available for all Europeans, even for European ordinary citizens, not only health professionals. It certainly contains information which is not valid in most of the European countries. Still it is available there.

My understanding also is that in this country, the British Medical Journal is freely available. I think it contains information which is off-label, investigational drugs and product information and labeling which is against the principles in this country for that very same product.

I feel that the group is having the view that Internet is only one additional media. We already have some other media where this all is available. Does it make so much difference if we use Internet?

MR. ROTHSCHILD: It is an FDA question.


DR. NIGHTINGALE: Thank you. It is not so much a question as a comment. I really shouldn't be the one to speak for JAMA, but they certainly publish all over the world for specific markets. I know that the editorial content varies by whatever market they are in.

I would assume the advertisements also are geared to those particular markets as well. So it is something to keep in mind and we probably should have somebody comment from JAMA. I know there is great concern as well in this company about the ads in journals that come in.

The Lancet, for example, is published--there is a U.S. edition. I don't want to go any further except to say that it is a complicated issue with many other things happening.

MS. SIMMONDS: The British Medical Journal in the U.K. contains advertising aimed at the U.K. audience complying with the U.K. rules. But they have exactly the same, another version that is the international version which goes around the world and isn't seen by the U.K. market. So the advertisements in the international edition of the British Medical Journal are not subject to the U.K. rules at all.

Similarly, The Lancet, as you say, has versions, numerous types of publications suited for particular markets with particular changing for advertising. I don't know whether they change the editorial, but I know they definitely change the advertising.

MR. GANSLAW: I would say that, in general, surveying medical publishing for five years now that it is not uniform at all, exactly, that a given journal will actually develop a separate version for an overseas audience. Many journals are small. They don't have the kind of revenue to be producing different versions and the original ads do go overseas.

This is especially true for small cardiology journals from countries all over the world are, when they then become shipped to the U.S., are exactly as they were published. In even some larger journals, they will have local comment from the countries.

Maybe if you are collaborating with the local society and publishing in that country, you will have local comment. But the original material won't be altered in the least.

MR. MILLER: I guess I do agree that information will be accessed by other than the intended audience on a website and it will be accessed by other than the intended audience with traditional media as is done today.

The real difference is the speed and ease with the Internet. As I guess Todd mentioned in an earlier answer, it is going to get speedier and easier. We just need to recognize that we do need to have a reasonably logical framework and it is going to be easier for people to get information that they used to not be able to get so easily.

We feel as though as long as the information is clearly noted for the intended audience, whether it is geographical as we are talking about now, or even for the healthcare professional versus the lay public, as long as it is logically accessed primarily by that audience, meaning the correct domain-name extensions, and, of course, meets the regulatory requirements of the country for which it is intended, that that should be enough.

MR. McCORMICK: Just one brief comment. We have been considering people accessing information not intended for them in isolation, so we are conceiving of someone as a lay person coming in, accessing information that they, for the sake of argument, don't have the tools to understand.

But then that product of doing that frequently is education increasing sophistication and the ability to discriminate independently. So we are not dealing with a static process here either.

MR. GROSSMAN: Just to add to what David was saying about the ease of use, first of all, let me say I think passwords could be a disservice to everyone trying to go into--and it could be a nightmare trying to set this up and for people calling a company and asking for the password or just the logistics to do that.

But we didn't discuss the issue with language. If a pharmaceutical company makes an attempt to put the information in the language where these regulations are set up, that, in itself, could be a little bit of a hindrance for someone trying to get that information.

MR. GANSLAW: One comment on that and that is, in general, the language of medicine is English. Many journals in countries are still published in English and many, many foreign physicians read English and that is the language of the literature.

The European Society of Cardiology Meeting is all in English.

DR. HEIKKILA: This is true but I must bring the global view which is we all speak English in the Western world but there is a huge majority of people out there who don't speak English, who don't understand English.

So I guess this will be in the interest of anyone who is using the Internet to try to translate, at least to some measure, into the local languages; say, Japanese, or Chinese, maybe Swahili. I don't know how often you now try to translate your information into local languages. Is it always in English?

MR. GANSLAW: The College does work with companies all around the world that translate products and literature into the local language. That is the benefit. It makes it more easily accessible. All I was suggesting is that using the language exclusively doesn't really reduce access in a clean way because many physicians in other countries and in the U.S. have dual language abilities.

So if it is available in English and you are trying to block in from the Spanish world, they can probably pick it up.

MS. GUARINO: I would imagine, though, that FDA is more concerned with the impact on consumers than on medical professionals. In fact, consumers in even the European countries are less likely to be able to utilize information that is in English if they are not in an English-speaking country, although I am not sure that that is necessarily the deciding factor.

The other thought that I had was that I wonder how much attention is being paid or if it has even occurred to those who have the Web, the companies that have websites, who their intended audience is. I am not sure they are thinking globally about that.

This may be a case where more advice by lawyers and regulatory people to the business folks who are working on company websites is in order. I did some checking with my colleagues in Europe and Australia and I got some feedback from them, particularly from folks in the U.K. who said that they believed, at least in the U.K., that there are a lot of legal concerns that are as much product-liability oriented as regulatory in nature on the parts of companies because of the legal requirements where if you were out of compliance with the regulatory requirements, you leave your company open to product liability perhaps more so than just the regulatory sanctions.

DR. HEIKKILA: Anyone else?

MR. EVERS: I think we have to be very careful when we talk about this consumer lack of knowledge or ability to discern what in that scientific information they shouldn't be getting. You have got to remember these laws were written 40 years ago, the laws that the FDA is operating under, 40 and 50 years ago.

Back then, that might have been true that the average consumer was incapable of understanding the scientific papers and so we better shield them from them. But today's Internet user is highly sophisticated and they are searching out this information. They are going to get it one way or another.

I know we are not supposed to look at changes in the law, but we really may need to revisit that and recognize that these were paternalistic laws that were passed for a reason that was good 40 or 50 years ago.

MR. KLEPINSKI: This goes back to what I was saying in my earlier remarks today. What has happened is that I think consumers have passed us all by. Those of us among us here, the FDA or other parties that are interested in teaching consumers through a rote technique, I view it as not education consumers, but training them.

We are interested in informing them and having them march through a set of information with enough balance that they can't possibly go wrong rather than education where you read a little Marx, read a little Adam Smith, make your own compare and contrast and learn from it.

In the areas where we have tried to keep information away from consumers, they have just gone elsewhere on the Net. For instance, the fellow from Public Citizen that was plaintively pleading that we go back to 1979 and do drug advertising exactly the way he wanted it and no other way until we got that done, and when the FDA says we have got to do it just this way, and companies will comply--well, consumers are just ignoring all of us.

They just go elsewhere on the Web. There is so much information that that small amount that we are controlling through this route is just laughable compared to what they find elsewhere.

So the only result is that consumers will find information. The only parties we are cutting out are the device manufacturers and the FDA.

MS. SIMMONDS: I would just like to make a point about changing the law to respond to the point across the table here, that in the European Directive, it was as recent as 1992 when they decided to put a prohibition on advertising prescription-only medicines to the public. So that is quite a new law and that was implemented in the U.K. in 1994 as a result of being a member state of the E.C. So that is quite new.

DR. HEIKKILA: Thank you.

I think at this time we will turn to the FDA panel.

MR. TART: What I would like to do is just take a look a medical devices. Manufacturers have an opportunity to export devices overseas without FDA approval if they meet certain requirements--that is Class I or Class II--and there is reasonable assurance of what we call a 510(k).

Some of the things that we are starting to see on the Net are that manufacturers are promoting, or want to promote, their devices in countries other than the United States. In those countries there are uses that are not cleared in the United States. Some of the devices do not have legal authority to be distributed in the U.S. but they can be sold overseas.

From the Center for Devices, we have concerns both how the devices are promoted to consumers and to physicians and we have certain restrictions on us from the old laws, as you have been speaking about, that devices are not promoted for uses that they are not cleared for and they are not essentially misbranded or adulterated.

But I think manufacturers would like to have an opportunity, and what I thought this session would address somewhat, is whether or not you think there is a mechanism to use the Net to promote products overseas in other markets for other uses that aren't cleared in this country.

One of the things I think you ought to look at is even though we have looked at the Net as another type of medium, there has been a lot of concern that it is not much different from any other form of communication. Disclaimers have presented a problem both from our standpoint and yours.

So I just thought maybe you should look at the Net as an opportunity, maybe a way to present information overseas or in other countries that wouldn't run in conflict to U.S. laws.

DR. HEIKKILA: So my understanding is that medical devices are in a different position in this country than pharmaceuticals.

MR. TART: No; I didn't say they were in a different position.

DR. HEIKKILA: I am just trying to clarify the situation because the understanding is that, concerning pharmaceuticals, even exportation of those to certain countries requires FDA approval.

MR. TART: Certainly Class III medical devices have required FDA approval before they can be exported overseas. But there is an opportunity for manufacturers to export what we call Class I and Class II devices overseas before they are cleared for introduction into commerce in this country.

MR. KLEPINSKI: I am a device-manufacturer representative. Does anybody else do devices here? Unfortunately for the early part of your question, Mr. Tart, we don't do that many Class I devices and the number of Class II is relatively small so we are not fairly representative of the full panoply of device manufacturers.

I would like to broaden your question a little bit. It just isn't us wanting to export from this country. We manufacturer in at least five countries outside the U.S. now for different devices. Some of them, the same devices that may be manufactured inside the U.S., outside the U.S. And we are selling them in a whole different set of countries.

So we look at the Net, while we probably wouldn't use the word "promote" that you use--I understand you are bound by the statute, that you use "promote" and it is a term of art--but inside the company, we probably use the Net more for information dissemination.

We don't view it as, perhaps, an advertising medium but a way to send information. Some of that falls in your class of "promote." So it is not simply going out of this country but into the rest of the world, but an interchange between all of these various countries.

So, as I see the Net, there is not way to nationalize it and to talk about it as information flowing out of one country. I think we have to look as the net as information coming on from any of these trans-national parts of Medtronic or any other company, and who are the people that are going to have access to it and how are you going to make sure that they aren't misled by it.

This is why my earlier comments said the pure banning of information, saying you can't get a certain type of information, is already slipping away from the FDA because there are so many sideways ways to get into things without any fault on the part of device manufacturers.

This is going to make it harder. I think, realistically, we are just going to have to recognize that the Net is an international thing and that we can label and disclaim so that the U.S. information cannot be distributed and viewed as promotional. But I don't see how we can realistically keep it off the net without taking extraterritorial authority and saying that you are going to control what the citizens of every other nation in the world can read.

MR. BLANDER: First, I would like to concur with Michael Evers on my left in terms of the consumers. We are talking about a very savvy group out there in terms of what has happened over the past five years. Now, we have consumers who are enrolling in clinical trials and other types of studies right there off of the Internet.

There was a comment that was brought up earlier this morning from a gentleman representing the Australian government and we looked at it terms of tabloid medicine. I charge over here at this table that yes, I do agree that there is an opportunity here to look at the positive side of things.

If we do have these standards and we do have organizations that rise up the criteria and do evaluations of disease-specific processes that include devices and other types of pharmaceutical products, then the type of information available out there will be good standard and not just the tabloid information, but that that can help educate all consumers out there on a global basis.

DR. HEIKKILA: Thank you.

Any other comments from FDA?

DR. BAYLOR-HENRY: I would like to direct this to the representative from SmithKline and Glaxo. From a regulatory perspective, how do you distinguish between a promotional activity on the Internet versus a promotional activity at an international meeting, particularly when the international meeting is on U.S. soil?

MR. McCORMICK: That isn't my area of expertise so I would like to pass it over to David.

MR. MILLER: It is not really my area of expertise either. I am not in the regulatory shop. I think what you get into are a couple of things. One is the two-way communication which we haven't touched, at least in this session. I apologize; I wasn't in the earlier sessions.

But I think that is where it comes into play more as far as what you do and can't do. Again, I don't know what the difference is between international rules as far as two-way communication exchange versus U.S. rules.

Was there anything specific that you were wondering about?

DR. BAYLOR-HENRY: I guess where I am going with this is that there appears to be, or at least what I am gathering from the discussion, is that there appears to be a need for a different standard on the Internet versus, say, promotional activities at a meeting that is taking place in the U.S., but an international meeting where there is a strong international following.

MR. MILLER: I guess we would think that the same--I hate to come back to logical framework. I am not a lawyer. But I think the same logical framework would apply. I think that what you can and should do in an international meeting would be the same thing that you can and should do within an Internet site, assuming it was meant to be an international site and was designated as an international site.

If it was designated as for U.S. consumers or U.S. healthcare professionals, we would direct it at that. We acknowledge that others could join on.

DR. BAYLOR-HENRY: So, following up with that, if you would not promote your product in the U.S. at an international meeting for a use that is not been approved in the U.S., then, gathering from what you have just said, then that would also be inappropriate on the Internet?

MR. MILLER: Again, as an international site; yes.

MR. KLEPINSKI: I would like to object to your statement that logic and lawyers are mutually exclusive.

MS. SIMMONDS: If you want to move your international meeting to the U.K., we do have some guidance in our Code about promotion of products for indications not licensed in the U.K. but to be displayed at international meetings held in the U.K.

If you are interested, I can continue. If not, I'll stop.

MR. VANCE: As the Glaxo Wellcome regulatory attorney who is here, perhaps I can answer that question. We have so far followed the FDA rules at international meetings. We have not had anything besides the U.S. materials.

Personally, I think that is absolutely wrong. I think what was done by some other companies this year at ASCO, which is the international oncology meeting and was done at ITCAP which is the international antiinfectives meeting, they had booths that were their U.S. booths. They followed FDA guidelines. They had booths that were international and they followed what was appropriate for their international customers.

That is the right way to go.

DR. HEIKKILA: Thank you for that. The audience will have later on, also, a chance to comment.

MS. STIFANO: Bits and pieces of this have been addressed by previous comments, and this sort of tacks onto what Doug McCormick was stating earlier, so I wanted to repose it to the group and see if there were any ideas.

We heard that the language of medicine is English so that is obviously not a way of blocking access, if you would, to information. But in keeping with trying to figure out how can you play by the rules of the country and disseminate information on the Internet, either a U.S. company disseminating information that is off-label in another country, or another country providing information to their physicians that would be off-label here, do you have any suggestions?

MR. McCORMICK: Unfortunately, my most constructive suggestions depend on the basic good faith of the user and that is to get them to profile themselves in a useful way. Perhaps this profile will be discarded at the end of the session--to guide them either to use database methods to guide them into the appropriate information or to lay out the site so that it is clear that this is U.K. information over here, this is U.S. information over here, the Belgian information, the Japanese information.

Nobody has the resources to put all that stuff up at once. And then we can profile by professional status, healthcare professional or not.

These are all more or less easily defeated by bad faith. I hesitate to contradict some of the other people on the panel, but I don't see it as being an insuperable obstacle to institute an easy method of identification and profiling of a particular professional group. It is just time consuming and expensive, but I think it can ultimately be done fairly inexpensively on a per-use basis.

I think that that is one of the objections; the expense.

MR. GANSLAW: I was going to agree with that first part of the statement. I have seen many sites where you simply have the flags of the different countries. In many cases, there are good, new sort of publishing techniques that allow you to have different languages if you want under each of those flags.

There are several sites up that do just that. Essentially, you pick the flag of your country before you go in and look at that information. It asks you where is your country of origin. I won't address the second part because I think we have covered that.

DR. HEIKKILA: Any other comments from the group now?

DR. BERNSTEIN: I have a question. I guess it is more toward Heather. I was hoping that some of my question--I had it when you put it up before but I was hoping that some of the discussion would come out here. What you had put up there, if I recall correctly, is that the Code applies to British companies and it applies to information that they put on within the U.K. and that if it is information that is outside of the U.K., it only applies if it is regarding a product in the U.K.

How do you distinguish that given if it is English language on the Internet and in terms of what the intention is of the person who is putting the information on the Internet?

MS. SIMMONDS: As I said in my presentation, we are all talking very theoretically on the Code of Practice Authority about these issues. The U.K. Code applies to companies in the U.K. not just British companies, companies that operate in the U.K. If they are pushing up information on the Internet, the U.K. Code would apply.

Sometimes, though, you can distinguish because products often have different names in different countries. The international non-proprietary name is the same, but sometimes the brand names are quite different.

Clearly, if a U.S.A. site, say, talking about a product and then went on to say, "In the U.K., the product is called such and such and you should make sure you go ask your doctor to prescribe it for you," that is when we may have jurisdiction.

But it is very difficult to talk globally. We would have to sort of judge each case on its merits and come to some sort of pragmatic agreement and way to process the complaint if we receive one ever. I am sure we will. It is only a matter of time.

DR. NIGHTINGALE: I have a question for Heather, also, and that is has the ABPI considered bringing this issue at all to the IFPMA, for example, as a worldwide issue?

MS. SIMMONDS: The IFPMA, which is International Pharmaceutical Manufacturers Trade Associations, where all the individual country trade associations are members of this international organization, have, as I understand it, made some sort of progress with the Internet.

They had a meeting last week where, I understand, it was discussed. I didn't attend that meeting and I haven't had any feedback from that meeting, but I think they are looking at the issue. I don't think they have sort of gone any further with it. But I think that they would say that their code would apply.

They do have an international code and that would apply as the minimum standards. But, of course, it is so different in each country. Some countries have got much more laws than just the IFPMA Code. Some of the Third-World countries, for example, only just have the IFPMA Code.

I think it is fair to say they are looking at it, but I am not really sure how far they have progressed with it. I sort of left before the person at this meeting came back so I couldn't discuss it with them.

DR. HEIKKILA: Thank you for that.

Can I now turn to the audience and ask people who would like to take the floor to go to the microphones.

MR. SILVERMAN: Hi. My name is Harold Silverman. I am with a firm called Interscience. We are a international global medical-communications firm. Two comments, one on the language of medicine. While the language of medicine and medical professionals may be English and, in fact it is English, it stops pretty much at that point.

We deal with journalists all over the world and find, surprisingly, that journalists in many countries don't have as substantial a command of the English language as you might believe and so, frequently, materials need to be translated into Italian and Spanish, in particular, for the use of those journalists who would then interpret that material for their own readers.

The second comment has to do with the question that was asked by FDA on promotion at international meetings. In our case, when international meetings are held on U.S. soil, we are very careful to separate those activities that are carried out for primarily European and U.S. journalists because of the need to be aware, remain aware, of different regulatory requirements.

When international meetings are held in other parts of the world, typically, as far as the U.S. is concerned, the number of U.S. journalists that are attending is minimal and so they tend to participate in the same, at least from our standpoint, promotional activities that are carried out for European journalists.

MR. MULLER: My name is Mike Miller. I am an attorney with Eli Lilly & Company and its U.S. affiliate. I had two comments. The first addresses the issue of the location of the server. I know we discussed that at great length.

I think it truly is an irrelevant issue. People can access a server that is placed in the U.S. anywhere in the world. The same goes for anybody here in the U.S. locating a server or accessing a server in any other country. I don't think this technology is as advanced as what we have discussed in terms of practical implementation.

Theoretically, I think it may be available but, currently, it is practically not available and very costly. I guess I would point out that the most important thing about the information, and we have talked about it before, is the accuracy and integrity of that information.

The only way for the pharmaceutical companies to control that accuracy and integrity is to have control of the server. If they do that in one place or several places, there shouldn't be a mandate that they are required to have several locations to control information. It is too difficult to do.

The second point I have is about the possibility of, again, parcelling the information that is on your Internet site for different countries. This really goes to a fundamental legal question, and that is what is the jurisdiction of the FDA.

I think the FDA needs to decide what that is, what they can actually impose or regulate, and then I think they need to make a decision as to what constitutes the intent for use in that jurisdiction. I think, perhaps, the easiest solution to this, and I hate to pose a solution because obviously you have to build a consensus and things like that, but what the British have done and the ABPI has done is a wonderful precedent for what we could do here.

If the FDA followed that lead, then I think a number of countries would follow that lead around the world and I think we would have a very workable and practical way to deal with the Internet with respect to pharmaceutical communication.

Thank you.

MR. EVERS: I am not sure how they are doing it but I know that the country of China announced that it was going to be blocking a lot of information coming into the country. They must be doing that with some technology. I think they control Internet service providers.

MR. McCORMICK: I have been waiting all afternoon to use this. It is the "Great Fire Wall of China." They are using existing, establish fire-wall technology and they are just blocking out everything that is not Chinese unless it goes through their gateways.

DR. HEIKKILA: I can also say that there is a normal language barrier there based on my almost weekly dealing with the Chinese. For instance, in China, very few speak English. Very few understand English. We should remember that this is about 20 percent of the population in the world.

But there is one remaining comment from the audience.

DR. GREBENAU: Mark Grebenau, Sandoz Pharmaceuticals. I just want to raise what is the converse of an issue which has been raised here. To a great extent, we are talking about sites maintained by U.S. pharmaceutical companies which could be accessed by people in other parts of the world.

The converse to that would be a large international pharmaceutical company in another company which puts up a webpage. That webpage can be accessed by people in the United States. Quite clearly, unless I am completely wrong, the FDA would probably not have any jurisdiction over that large company which is in a foreign country.

However, they would have jurisdiction over the wholly owed affiliate subsidiary of that company which is in the United States. Would there be any interaction going on there in terms of making suggestions or somehow saying, "This is being done by an international firm. You are an affiliate of that firm and the information on this site is not appropriate for a U.S. audience because it is outside of labeling," or whatever.

DR. HEIKKILA: Thank you. I can see that the audience is extremely excited about this point and I would like to turn to FDA.

Did you have any of these kinds of cases already or how should you, perhaps, react to this situation? I know you haven't formulated your policy yet, but--

DR. BERNSTEIN: I was just going to answer that by saying that is why we are having this meeting.

DR. HEIKKILA: Thank you. But we are still excited.

MR. ARMSTRONG: Neil Armstrong, Teleflex Medical. I represent an international company. We manufacture in about ten countries throughout the world. We have distributors in probably four or five times that number of countries.

My nightmare scenario is, by acquisition, I have inherited a distributor in a third country, maybe a Third-World country. They have legal rights to all my advertising copy and they have a 20-year distribution agreement. I inherited this when I took over a company. I cannot change it.

They decide, unbeknownst to me, to put up a webpage and to make it look not they are a distributor but to use my name, to use my logo, and only put any reference to themselves in very small print somewhere on a back page.

They also are with a large service provider and so they get a ".com" address. So, apparently, there is something that looks to nearly everybody like a U.S. site with my name smothered all over it. It may be perfectly legal in the third country where it is on a server, but it doesn't meet FDA regulations.

The first thing I know about this site is that I get a letter from Mr. Tart's office saying, "What's this??"

DR. HEIKKILA: I should remind you that they haven't formulated their policy.

MR. GRACE: My name is Frank Grace from Synermed. Following up on the Sandoz question there, if you want to complicate it further, and we all know this, you have companies that market products in the United States that are completely different from the rest of the world.

So the rest-of-the-world company can put up whatever they want and the U.S. company can either be victimized or not victimized or challenged or not challenged. So the potential for international invasion into the U.S. goes beyond the very tightly controlled SmithKline, Glaxo, the few other companies in this country that will further complicate it.

So I think the way you establish guidelines and responsibility is going to be critical. Going back to the server thing, as much as I have heard here today about having one server site not making a difference, what I have found is that most people want to have it on separate grounds so that you don't think that they are actually controlling everything that goes in there, because having it on U.S. ground would imply, therefore, they have complete control over it where, in fact, the autonomy of the various national operations may be such that it is simply an economical reason for housing it in one location as opposed to a control reason.

DR. HEIKKILA: Thank you. One more brief comment and then we will move on.

MS. TODD: Leslie Todd, Vivus. A quick question. The company may be in the U.S. or not in the U.S. The site may be hosted in the U.S. or not in the U.S. What about promotion? If it is a U.K. company with its site hosted in the U.K. but they are promoting in the U.S., say a sales rep walks into a doc's office and says, "Hey; you can get some great information on this on this site."

What about promoting a site?

MR. ROTHSCHILD: I just wanted to give the FTC's perspective on this question about jurisdiction over entities located outside the United States. We have clear jurisdiction over commerce with foreign nations, and we have exercised it as a matter of discretion.

We have seen a lot of companies that are moving offshore now and targeting U.S. consumers just as a means of avoiding law enforcement. So we have concentrated on that as a growing problem. We have recently brought law suits against several Canadian companies and Canadian individuals located in Canada.

Their businesses are Canadian but they are sending in direct-mail solicitations or doing telemarketing to U.S. consumers. It doesn't make any difference to us as a matter of jurisdiction. There are simply practical issues, of course, in enforcing an order that we obtain against a country located outside the U.S.

But we certainly hold them to the same standard that we hold U.S. companies to.

DR. HEIKKILA: Thank you. I think we have to move on now. We will take Question No. 3. "For purposes of this question only, ADF has its world headquarters in the United States but has a strong presence in markets throughout the world. ADF chooses to have one central fileserver located in the United States.

"ADF is aware that many countries throughout the world do not permit direct-to-consumer promotion of prescription medical products. However, the U.S. does permit this practice. ADF chooses to post promotional material under Internet directly to consumers following the current U.S. regulations.

"Join ADF in their discussion of how to address current regulatory authorities in countries where direct-to-consumer promotional is not permitted."

This is a very interesting question and, of course, we have experts from outside the U.S. here. Maybe we will start from this in the group. Who wants to volunteer?

MS. SIMMONDS: I'm sorry; I seem to be monopolizing this. If I were ADF and I had to defend this, I would say that the information on the Internet is designed for the U.S. audience. It relates to U.S. products. It is totally in accordance with the FDA regulations. And that would be the end of my defense.

We in the U.K. would accept that providing it didn't have a little p.s. on the end; "Have you tried such and such in the U.K.?" or something like that. Providing it was purely for the U.S. audience in accordance with the U.S. law, I think ADF could defend it.

DR. HEIKKILA: I think we will go to France now. We have a colleague from France here.

MR. ALLENOU: I think I have really nothing to add to Mrs. Simmonds from the United Kingdom. It is exactly the same problem in France. If you advertise, you will be under the French rules so you have to come under the French rule with the French regulatory agencies and the French health policy on drugs.

If you don't follow those rules, you will get a penalty for whatever your site is in France. But the fact is, if your site, your website, is not in France, you are not under French law. That is a problem right now of the French regulation on Internet issues globally and on health Internet issues.

Right now, you are under health advertising regulation, so you have to follow those rules on drugs and pharmaceuticals and biologicals.

DR. HEIKKILA: Can I clarify. Did you say that if your information in Internet is not in French--

MR. ALLENOU: Not in France.

DR. HEIKKILA: If it is not in France, it is not covered by French laws. If it is in English--

MR. ALLENOU: You can be sued from France if you are not in France. I can sue you--for example, the last case that happened early this month was about a mail-order service that was created in a European country. You can get drugs by mail from that country from a provider.

But France cannot sue the provider because he is not in France. That is the issue. But, actually, they are thinking about suing maybe the drug manufacturer if he is not aware of it. So it is a very complicated issue because there are lots of actors. If you are not in France, you are not under French law.

MR. BLANDER: I believe there were two comments from people on this panel that gave some very good solutions. First, John had mentioned that based upon any medium, really, if it is an illegal activity, then it should be deemed illegal. If it is being promoted outside the boundaries that a product is approved for already, then I would see some action should be taken.

Also, Doug had mentioned there are certain types, and we all agreed here, that technology and the semantics of that shouldn't be the focus of this, but there are certain types of browsers and other types of tools there that you can, from an intelligent perspective, really hone in on the user in terms of where they should go and how they should perceive and view that type of information.

MR. VAN DER BERG: Just before I left, I contacted our National Ministry of Health and asked them what they would do in a case like this. They answered me that they had more than enough on their hands, actually, as it was so they would probably do nothing about even, even according to EC rules, that would be very hard to detect.

DR. HEIKKILA: I think this is one fact that we remember in this room. We did, some two years ago, surveillance on some 185 countries where they are in terms of drug regulation, drug regulatory authority. To summarize it, one-third of the countries had drug regulatory authority in place and legislation and regulations.

They were, apparently, able to implement the law. One third had something in place, a law which was something they could never implement because they had borrowed it from somewhere or it was a traditional law they happened to have, or they did not have enough resources to do anything in terms of drug regulation--or something, but not all.

And then there was about one-third of the countries which had nothing at all. So we are really in a world where there are a number of countries where this kind of discussion is kind of cream to them, what we are having here today.

But I would like to have more comments on this.

MR. VAN DER BERG: I would almost paraphrase Jurassic Park; "Internet will find its way."

MR. KLEPINSKI: There are some things other than regulatory agencies that could be a problem in foreign countries. I don't want anybody to ignore other issues. There are country-specific laws; like I am told in Germany that one cannot do comparative advertising.

It will be an open question as to what happens when you are selling into a country and have Internet things that may compare your products with others. So you can't just concentrate on what the regulatory--there can be a whole wealth of local laws to consider.

DR. HEIKKILA: Yes; and one should also add that consumer organizations are getting more and more active everywhere in the world and that may be the starting point for regulations.

MS. GUARINO: I would add that, as I said before, it is product-liability concerns that I think are very high on the list of concerns that many companies have. As I read Question 3, the only difference between this and the other questions we were discussing is that ADF is now a company that has world headquarters in the U.S. as opposed to being a "multinational company."

I think as far as product liability concerns go, that difference may not be all that significant if there are consumers in other parts of the world that are potentially injured particularly where we are told, in Question 3, the company has a "strong presence" in markets throughout the world.

That, as a lawyer, concerns me. What does that mean? I think the jurisdictional issue may be, perhaps, more complicated particularly for other legal issues like product liability.

DR. HEIKKILA: Any other comments?

MR. VAN DER BERG: Maybe one more and that is not so much to ADF as to FDA. I think that if you look at what the European community is doing right now, it is not very much. I think they are, more or less, looking towards America to see what is coming out of there because that is where Internet started, more or less.

So there is an extra big responsibility here.

MR. ROTHSCHILD: I just wanted to note that the European Commission has published a Green Paper on commercial communications. Some of you may be familiar with it. Just in response to the points raised about there being other restrictions on marketing, transporter marketing, this Green Paper addresses possible ways of dealing with those inconsistencies within the European Union in order to make the single market more of a reality.

So there may be some useful discussion in there for the FDA's purposes.

MR. EVERS: It seems to me that what we are talking about here is protecting the walls that have been erected around these nation states over the years. If anything, the Internet is leveling and helping those walls collapse. And I wouldn't want to be in the FDA's shoes as they try to protect the United States from all of this information that is flowing around in the world nor would I want the world deprived of the information that is being generated here in the United States.

Those walls are coming down and the Internet is having a tremendous impact on all of these nation states.

DR. HEIKKILA: I think the main issue here is that pharmaceuticals are a specific group of products and they have, in most of the countries which regulate them, approved product information or approved labeling. And that should be always respected. Whoever is putting anything in Internet should clearly indicate that this product information has been approved by that and that country and is valid in that country only.

Once that has been done, I think we don't have so many additional reservations, at least outside of the United States.

Can I now turn to the FDA panel and ask if you would like to raise some points.

DR. NIGHTINGALE: Just a specific question for the FTC representative. This Green Paper you discussed, does that have a special Internet component to it at all?

MR. ROTHSCHILD: As I recall, it does not. I haven't looked at it recently, but I don't believe it does.

DR. NIGHTINGALE: Is it something that cuts across the various Director Generals at the Commission?

MR. ROTHSCHILD: It is issued by DG15, I think, internal single-market directorate.

MR. VAN DER BERG: I don't know whether we are talking about the same paper, but I have a copy of this EC Rule about specific medicines, and they don't talk about Internet yet.

DR. NIGHTINGALE: It think we would like to get copies of both of those.

DR. HEIKKILA: Any other points from FDA? I see that people are moving towards microphones in the audience. If you don't have any additional points, I will let the audience react now.

MR. HEIDENREICH: Vince Heidenreich, Bayer Corporation. Just by way of a friendly reminder, these last recommendations would necessitate that the FDA change the rule that proscribes the use of characterizations that the drug is approved for any given use in the United States as a part of its advertising.

MR. KUROMIYA: Kiyoshi Kuromiya, Critical Path Aids Project. I just wanted to bring up two points as a consumer. We realize, at least in the HIV community, that 90 percent of the people affected by HIV are not in North America.

Because of that, we have made some of our own efforts. For example, we are a small organization but we are providing treatment and prevention information in ten Asian languages. We are doing this using currently available technology simply by taking existing documents and scanning them and loading them up as graphics files on our webpage.

We also, in collaboration with John James of AIDS Treatment News, have just started a new communications medium using the lowest common denominator of this medium, E-mail, to communicate with individuals and organizations in developing countries, E-mail at critpath.org.

Our efforts are dealing with the entire community of consumers around the world who have needs for the best possible information on treatment and prevention.

DR. HEIKKILA: Any other comments from the audience? The group?

MR. BLANDER: I would like to augment to that comment that was just made. There is a term that I have heard that is FCD, the freest common denominator. There was some work being done going into a Third-World country. Essentially, the questions that were being asked were how would this influence the actual decision makers.

I guess there were several constitutes here that are looking immunosuppressive therapy, and that is a fine example of there may be some information out there on the Internet where the consumers could be educated, but really is this going to influence the patterns of prescription because we are looking--it was mentioned, also, before, who is the target audience.

Just because now the consumer is more educated doesn't necessarily mean that they can gain access to that type of therapy.

DR. HEIKKILA: Other comments? We seem to have time. I wonder if we could go around the table and if each one of you could summarize, say, in one minute, what you would wish FDA to do and what you would not wish FDA to do.

Is that too polite for you? Okay; you can say whatever you want, but in terms of these two topics.

MR. ALLENOU: Go ahead. Let me think about that. I pass my turn.

MR. CALFEE: I hope the FDA is able to resist the impulse to treat the Internet as a sort of enemy of their regulatory philosophy because I think the tendency of the Internet is a market-perfecting device. It is improving the marketplace. It is not just giving more information.

It is arousing spontaneous solutions to problems, and we are going to see a lot more that we haven't seen yet. We are going to see things in the way of certification of sites, certification of sources of information. A lot of what the FDA has been dealing with in the past relates to problems that, to a large extent, may well be eclipsed by the Internet.

That is what I suggest as a regulatory philosophy.

MR. BLANDER: I would have to concur with that that whatever policy that is taken in the future, that it is one of leniency and that one looks at the Internet as an opportunity of free expression, and that any type of action or type of legislation that is promoted to restrict that type of information would be a great disservice to the consumers who are really able to learn more about the products and services the industry can offer to them.

MR. EVERS: I would just remind the FDA that it is a U.S. agency and, as such, it is governed by the United States Constitution and pronouncements by the U.S. Supreme Court. Earlier this year, the Supreme Court rendered a decision in which it struck down some advertising laws dealing with liquor prices.

One of the statements by Justice John Paul Steven said, "The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good."

I think that as we move into this new era of consumerism, of empowerment and of this crossing of international borders, that we just need to be very careful. I know that you will be seeking other input from other countries and just recognize that we have to--one speaker, I think yesterday, said, "Let's not stifle this infant with too much regulation."

MR. GANSLAW: As I have been thinking about this whole issue of direct-to-consumer, I am not so sure that the Internet is direct-to-consumer. It is sort of direct-to-consumer in the reverse, if you will. People are seeking out this information. This is not a broadcast medium. I think that that needs to be kept in mind in terms of how it is regulated.

The paradigm of a doctor asking for a reprint of an article on a use that is not approved is very applicable and you can analogize it to the Internet. Somebody is requesting. Every click of the mouse is ask, ask, ask.

At the maximum, at least with regard to the international situation, allowing sort of a banner of different flags, allowing that to be the way that people can get information that is responding to their particular country's regulatory guidelines, I think that is probably as far as regulation needs to go.

MR. GROSSMAN: It was mentioned yesterday that there is going to be video and other types of technology that are going to be growing here on the Internet. As I stated before, I think we are going to have a lot more international as well as domestic surfers out there.

It seemed that we all agreed that it was okay to have one central server to have your information available, but to categorize it in such a way that it would make it easy, such as flags or something, for individual countries.

Lastly, I just want to say that I think you should continue what you are doing with putting your heads together with other international regulatory agencies and see what they are doing.

MS. GUARINO: I would repeat kind of the theme that we heard yesterday which is to say that FDA should, to the extent possible, look at analogous situations under the current regulatory scheme involving other media as it decides how to regulate the Internet, and will probably find that, in most cases, the current regulatory system is quite adequate.

In this international arena, I absolutely would agree with those who have said that for FDA to work with its sister regulatory agencies around the world is critical. I would also urge FDA, as it has done in the past, to play a leadership role and demonstrate to other countries that there are ways to communicate to consumers in areas where the rest of the world is still even less inclined than we are to permit those communications.

But I think that working with, basically, the rest of the world, just like within the country, working with the FTC and the states, is very important.

MR. KLEPINSKI: I agree with everybody else. I urge the FDA to concentrate on its strong suit of looking for truth and fair balance and accuracy rather than ways to ban particular types of information.

I think that the audience of physicians and, now, of consumers has changed. I really enjoyed the comments of the ACC, the American College of Cardiology, representative yesterday who said he couldn't understand the fine distinctions that the FDA was making.

I think that is shared by a lot of physicians. We have become a little insular. Industry and the FDA work together on complex sets of instructions with complex details on typefaces, and we are sort of losing track of what the physicians are looking for.

This is a the time when we are going to go back and apply all those regulations. Which will work on the Internet? Just to look at what we are trying to accomplish and whether we are, as people said here, trying to protect people from things they don't want to be protected from.

The Internet is just busting forth with information and it is a time to check to see if we are giving people what they need.

MR. McCORMICK: I have to emphasize I am speaking for myself, now. First, a quibble with a statement that has been made several times during the meeting that people find only what they ask for. In fact, when a hyperlink is presented that is an offer, the offer precedes the request.

So we have to balance those. You are picking from a restricted menu. I say that against, perhaps, my self interest.

The other is that clearly FDA doesn't need to be reminded of its mandate for public protection. But in something that is evolving the way the Internet and the World Wide Web is, I would urge you, again, in common with some of the speakers yesterday to adopt the reasonable person's standard, to judge companies on whether they are making a good-faith effort to get appropriate information to appropriate audiences given the vagaries of the technology today and understanding.

Finally, I would say that that technology is evolving and we have to maintain a certain openmindedness of flexibility to allow the industry and the regulators to embrace new solutions that will better help us reach the right audiences with the right information, and that that process should be allowed to go ahead as long as it is carried out in good faith.

MR. MILLER: I want to thank the FDA for assembling this panel and for allowing me to be on it. I guess to follow on to something that Jack said, I think that the FDA has done a wonderful job thus far of resisting the temptation to regulate too early. I want to applaud you guys for that.

I think that I am aware, at least, that for the better part of this entire year, there has been a good deal of interaction, dialogue, with a lot of different facets of industry as you guys try to understand this and see it moving ahead.

I think Internet years are like dog years; there are probably about six or seven with a calendar year. I expect that you guys are a lot smarter now as far as what you really need to do in this area and what you really can do in this area. I think that your restraint should be applauded. I think you have done a great job there.

As far as specific issues, again, just to highlight them as far as information, I think if it is presented for an intended audience, whether it is geographic or whether it is healthcare professional versus consumer, as long as it is clearly noted as such, as long as you have the appropriate trappings around that such as you can with today's technology, recognizing that today's technology is going to be different from tomorrow's technology, and you follow through with that.

There was one question from the audience as far as what do you do if you have a U.K. site and then some people in the U.S. start promoting it to U.S. doctors. We can't do that. We should recognize that that would be totally inappropriate from our point of view.

If we are going to hang our hats on the intention, we need to follow through with that and I would expect that we from industry would do that.


MR. ROTHSCHILD: I won't presume to offer advice to the FDA as to what to do because we at the FTC are struggling with these same issues of how to apply our regulatory program to the Internet. We know that there are no clear answers.

But I will say that in our philosophy in approaching these issues is that, as a general rule, advertising is good, information is good. It helps consumers make better choices in the marketplace.

We avoid getting involved in regulating speech unless it becomes deceptive or unfair. That is the approach that we are trying to apply as we look at the Internet.

MS. SIMMONDS: I would just like to make a point about if a medical representative in the U.K. went to see a U.K. doctor and said, "Look at this U.S. site about this product," it would be covered by our U.K. Code because it is a personal thing and the rep would be using that for a promotional purpose.

I think you have to find a pragmatic solution. Bear in mind, that healthcare professionals in other countries are entitled to information that might not be acceptable to the FDA given the regulations in the U.S.A. and, of course, vice-versa.

Given my limited experience with our guidance, I wish you well.

MR. VAN DER BERG: I would like to wish the FDA a lot of luck with the process they are going through and maybe urge them to be ask quick about it as possible because Internet is moving with the speed of light and that is hard targeting.

DR. HEIKKILA: Thank you. We are not at the end of this meeting yet but I would like to finish with this part of the meeting by saying that as I functioned almost for 20 years as a drug regulator somewhere there in Europe, I very rarely had rewarding days.

But I must say that my colleagues at FDA today have had a rewarding day. You have heard from the audience that there are loyal citizens there who fully trust in your expertise and in your way of planning your future concerning Internet.

I would like to thank the FDA panel as well as the group as such. I will turn the floor over to Dr. Nightingale.

DR. NIGHTINGALE: Dr. Heikkila, thank you very much for a great job and thanks to the discussion group and the FDA panel.

This, indeed, was, I think, one of the highlights. After all, it is the World Wide Web and the international issues are extremely challenging and you have all given us a great deal to think about and to work on. I think there are many, many good ideas here and throughout the two days. In fact, it has been two rewarding days, not just one, for us. Extremely valuable.

We have a few minutes. What I might do is offer to take some comments or questions from the audience, no more than a minute each, if there is an interest in doing that before I make a very brief concluding comment.

Are there any people who feel that they would like to make a one-minute statement at this point?

MR. ARMSTRONG: Neil Armstrong, Teleflex Medical, again. Sorry for that. Very interesting two days. I am sure we would all like to thank you for it. Yesterday, there was the mention, the rubbish is always going to be out there. The bad sites, whether they are international or just from irresponsible people within the U.S., are always going to be there.

The mention was made yesterday of some way of giving, possibly, a badge or an accreditation to show the viewer that you had now found a recognized, in some way, approved or monitored site. Maybe this isn't an issue for the FDA to regulate, it is for industry to come up with its own code of practice, its own code of ethics for our Internet site.

Perhaps, that is something we in industry should think about as much as the FDA.

Thank you.

DR. NIGHTINGALE: Thank you for that comment. Is there anyone else at this point? In that case, this has been an excellent meeting. It has met and surpassed our expectations. As I said this morning about the first day, this was amply carried through today.

We did get a tremendous amount of factual information and a very wide variety of views on all subjects which is going to be extremely important to us in our transcript. The presenters, the people in the discussion groups, the FDA panels and the audience all participated in this and we are very grateful for that.

There was, indeed, a wealth of information. I want to thank you on behalf of the FDA for all your input into these deliberations.

The transcript, as I said this morning, is going to be available in about two weeks. You get it through the Freedom of Information Office at FDA. We will also try to get it onto our website as quickly as possible after it is available.

However, what we would like you to do as part of this is, if you need to, to consult that as well as any thoughts or comments you have on the questions that were asked formally prior to the meeting or any of the issues that actually came out during the discussion today. If you would please comment to us by December 16--the docket is open until December 16.

What we are going to do, of course, is to take the transcript and discuss what happened here but also look at your letters, the comments that come in to us to the docket. So I would very much ask you to do that, and we have to have it by the 16th.

Our commitment is to look at the transcript and to look at the comments that come in and, as quickly as possible, to develop the appropriate position to take in this area. Obviously, we have heard your message that it needs to be done as quickly as possible and we commit to doing this.

So, again, it has been extremely valuable. I am pleased to have been able to play some role in this. I want to particularly thank Dr. Bernstein for all the work that she and her staff and the committee did in arranging for this, and Faye Fink as well and the many others who have assisted in the preparations.

So thank you all very much. We appreciate it and we promise to make good use of what happened here.

Thank you.

[Whereupon, at 2:50 p.m., the proceedings were adjourned.]


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