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Transcript of Direct-to-Consumer Promotion Public Hearing Panel 8

FDA Public Hearing

Direct-to-Consumer Promotion

Thursday, October 19, 1995

8:40 a.m.

Quality Hotel
3727 Colesville Road
Silver Spring, Maryland






MR. ABDULEZER: Good morning.


MR. ABDULEZER: It is my pleasure to address you. My name is Loren Abdulezer. My address is 60 Remson Street, Brooklyn, New York 11201. I am with Evolving Technologies Corporation. The views that we are presenting here are the views of our corporation. Additionally, we are not engaged in the manufacturing, packing, distribution, advertising, and promotion of prescription drugs or biologics or devices. The views that we want to present this morning are views which we hope will provide some informative information to your committee.

And, as I said, we have no financial interest of any type as stated in Item 4. The topic that we are going to be presenting here--

MS. PEDERSEN: How would you like to split your time?

MR. ABDULEZER: It is going to be a total of 15 minutes altogether.

MS. PEDERSEN: You will just go back and forth?

MR. ABDULEZER: Yes, we will go back and forth.


MR. ABDULEZER: The topic that we are going to be presenting today relates to the implications of using new technologies for providing patient information to achieve effective disease state management. Mr. Irving Schwab is going to be covering some of these topics now.

MR. SCHWAB: Good morning.



MR. SCHWAB : When we first took a look at this subject area or talked about a topic, we wanted to take something that was relatively simple to understand, simple to develop, and put together something which would take us two or three years out in terms of providing patient information. Our initial objective was to take a look and see what's out there now, and primarily for the consumer, what is out there is product information which is largely dispensed with a prescription.

The other item which is out there in the realm of patient information is probably a handout or something such as that which could be provided to the patient about the basic disease, and this is on a sometimes hit or miss basis, depending upon what the doctor or the dispensing physician or the prescribing physician or other organization has available.

The current status of consumer-type products are, again, one being to the product itself, which is provided with a prescription. A second may be a third-party position or statement from an organization. The last may be, again, the drug company patient information sheets which are handed out.

We think that there is, at this point, a need for continuity of information, a continuing flow of information. We see gaps where the information is sometimes provided and sometimes is not. On the basis of that, we saw an application for a new technology for the transition into electronic media from published media, and this can be accomplished via the Internet. Our thoughts behind this were that if we could provide a continuum of information to patients, that we would see improved health care and improved disease statement management, for we worked off the basic premise that with an information stream, individuals will take it upon themselves to follow directions, if they are available. The Internet has the ability to reach both the physician and consumer.

In terms of sourcing the data to be presented, there are two or three basic sources. Number one, we can go back to the basic people themselves who compile this information and put that onto the Internet, or specific information can be developed for it.

The bottom line of this, from a cost consideration point of view, that it is very, very economical. The costs are relatively very modest and it is possible to put together a data base or a source base for disease state management composed of information coming from the three sources.


MR. ABDULEZER: Part of the issues associated with transferring information onto the Internet is that, right now, it is a rapidly expanding domain.


MR. ABDULEZER: If you take a look at the next slide, it shows and identifies--I just pulled this off as of October 17, and if we look at it, roughly 4,000 new Web sites, Worldwide Web sites, are being added to the Internet every week. In the last couple of days, like 800 and 900 a day. The next slide?


MR. ABDULEZER: Here is a sampling of many of the medical sites that just have been added in on Tuesday, October 17. It doesn't matter that you can't read it. The point is that there's a lot of new information out there and coping with that information could be a rather tedious task.

What we want to do and what we would like to see happening is that to establish a number of Web sites whereby information can be centralized, presented in some digestible manner, some manner which allows people to browse through information.


MR. ABDULEZER: Here is a possible kind of format that could be applied in a Web page, in this case, a patient's guide to hypertension. There are various items in it with hypertext links, like what is hypertension, what causes it, why treat it, and so on--information that a patient has available and can look up.

There are several issues that are important that we have identified in terms of setting up these kinds of Web sites. First of all, there have got to be multiple modes of access to information. In one case, you may just want to browse through it, which is, in effect, what Worldwide Web had been pretty well known for. There are other capabilities.

Let's go on to the next slide now.


MR. ABDULEZER: Aside from the ability to browse, there are automatic links to multiple sites. The most important aspect about these automatic links is that information does not have to be in redundant form. You could have information residing on one site, and, in fact, the Web can point to it through multiple sources of information, and that makes updating information much easier and much more accurate.

There is also the possibility of two-way interaction, both in terms of doing things like being able to send e-mail to appropriate organizations and also to be able to conduct surveys, if that might be needed. The Worldwide Web environment also supports multimedia, graphics, sound, movies. So the point is that if information has to be presented which is specifically relevant and there's a lot to present, it becomes rather easy to do so.

We can also attach database facilities to the Worldwide Web. In that way, it becomes possible to search for information, find out information, generate new information pretty much on the fly.

Perhaps another aspect with the Worldwide Web facilities, and I'm not trying to promote the Web as the only vehicle but I think it is a valid one, is that information can also be transmitted in terms of stand-alone documents. Imagine, for instance, a package insert which has information that has to be presented in a very specific way. This can be transmitted directly to a patient and they can view it and it can be accurately presented.

The Worldwide Web, as you saw with a couple of the sample screens, in terms of presentation, while textually correct, the presentation or format may vary from computer to computer. That can't be tolerated with a package insert. That has to be presented a lot more precisely. In that kind of a case, a stand-alone document might take the form of what's called a PDF file, a portable document file format, which is clearly available and is now being used heavily in the industry.

Another important aspect along these lines is that documents that are transmitted in this form can also make use of RSA digital signatures, so that authorship and authentication of documents can be preserved and the reliability of that information becomes important.

So in closing, really the way we see this is that there are a lot of new elements in this technology that can be put to use. We believe it is in the interest of many organizations to look forward and to examine ways in which this particular technology can be enhanced.

Do you have anything else?

MR. SCHWAB: Yes, just one last point in wrapping up. The beauty of a system such as this is that it is accessible by anyone, be it a patient, a doctor, a clinic, so there is total on-line availability of patient information from any one of a number of sources. Currently, this information is not generally available. A patient does not have the ability to get specific disease state information every time a prescription is written. By going in this direction and creating a repository of patient information, what there will be is a central source that an individual can draw down from.

Now, again, the information can be contributed from any one of a number of sources, created in Web pages, and put up onto the system. It could be the responsibility of the individual supplying it to make sure that it's updated in the same manner as patient package inserts or full disclosure information is updated by the respective companies. That's it. Thank you.

MS. PEDERSEN: Thank you very much.


Our next speakers will be Wendy Borow and Jim Sandino.

MS. BOROW : Thank you. I'm Wendy Borow, and for ten years, I was with the American Medical Association as Vice President of Consumer Affairs and Corporate Relations and founder and President of American Medical Television's programming service. In those roles, many of you on the Panel know, I worked with you to develop guidelines for physician promotion in non-print media, particularly to much of your consternation, looking at the issue of scrolling and cable television; worked on guidelines for package companies' labeling and sponsorship identification of national health consumer campaigns; and worked directly with the agency to develop the AMA's guidelines for direct-to-consumer advertising.

Currently, I am President of Com-Med Interactive, the new media arm of Medicus. The Medicus Group is the health care arm of Darcy, Masius, Benton and Bowles, where I also serve as Senior Vice President of Medicus Group, U.S.A. Medicus has many clients in the areas of advertising, public relations, and medical education that span pharmaceutical manufacturers, other health care manufacturers, and other health care groups, and we clearly have a financial interest in this. My travel here has been paid by Medicus, although not on behalf of any specific client.


MR. SANDINO : My name is Jim Sandino and I am from Manhattan. That is my current address. I am self-employed. I own a consulting agency. I am an independent consultant with clients that are both pharmaceutical manufacturers, agencies, and other health care organizations and I also work very closely with the Medicus Group.

My financial interest, of course, therefore, is based upon those clients who pay me and I am happy to be here.

MS. BOROW: We listened very carefully yesterday to all of the testimony, and while much of it was insightful and we agree with most of it, we feel that there were three issues that were largely missed or touched on only briefly.

First, the issue of integration, the integration of any direct-to-consumer communication effort across all constituencies or stakeholders involved, and this includes the government, consumers, professionals, managed care, et cetera.

Second, the recognition that DTC is not just print and TV advertising alone but the entire stream of communications directed to consumers interested in the brand or disease state, including new technologies and new media.

And third, a true understanding of what benefits the consumer really expects, wants, and needs from direct-to-consumer advertising.

The changes in health care and the perceived disenfranchisement of medicine that comes along with the increase of managed care calls for the use of communications technology and messages to create new bridges between the physician and learned intermediary and the patient. But looking back to 1984, while the FDA began to allow direct-to-consumer advertising, the American Medical Association created policy which opposed the advertising of prescription drugs in media intended for the public. But in 1992, the AMA had to reverse itself, and I had the burden and honor, I guess, of the responsibility of making that happen. If the audience thinks the FDA is difficult to move, try moving the AMA.

The health care and the communications technology world had changed. The growing influence of managed care, the public's increased hunger for health information, the new medical education focus on the shared decision making role of patient and physician, the proliferation of non-print media, no longer adjunctive and "alternative" media, forced the American Medical Association to amend its longstanding blanket opposition to DTC advertising, creating new policy stating, and I quote, "that this method of conveying health care information can serve as an excellent communication vehicle for alerting consumers to new therapeutic treatment modalities, especially for those patients who may not be in routine contact with their physician, encouraging people to seek medical advise for conditions that might otherwise go untreated, and enhancing the patient-physician relationship by increasing patient responsibility for healthy lifestyle and thus fostering increased dialogue between physician and patient."

Let me make it clear that the specific guidelines were developed for use in AMA consumer vehicles, including print and electronic. A key component of the guidelines included simultaneous physician education materials to be provided by the manufacturer in recognition of the need to have a two-tiered approach to prepare the physician for the consumer.

Today, outside of the AMA, many of us in the communications world advocate simultaneous physician education with DTC and an advanced message to physicians about any DTC campaign which increases the potential dialogue between physician and patient, strengthens the role of the learned intermediary, and, quite frankly, from the manufacturers' perspective, makes economic sense.

But both the AMA and FDA guidelines have been reactive. The time has come to be proactive. The entire world of advertising is changing, as the communication landscape now includes the Internet, CD-ROM, place space kiosks, on-line services, direct broadcast satellite television, interactive television, interactive phone services, as well as customized print with one thing in common: Interactivity that allows the consumer to select and pull the information they want rather than having promotion pushed at them.

The FDA needs to recognize the implications of this new interactive information-driven world and allow the health care industry to more freely utilize all these media to foster consumer action at all levels of care--symptom recognition, diagnosis, treatment compliance, and necessary behavior modification.

MR. SANDINO: And it's action that is really truly the goal of any marketing effort, action that is driven by information. Prior to my work in health care, I was a direct marketer of consumer products. I marketed things through the mail, over the TV, over the phone. These efforts sought to identify the best candidates for marketing, those people who would become customers, not just buyers, people for whom the advertising would have to satisfy, not just sell or promote.

But I found that there were often hurdles or barriers to satisfaction, and the best way to overcome any hurdle or barrier is with information. This kind of delivery of information in direct marketing is a three-step process, basically.

First, you allow prospects to identify themselves by letting them respond to an offer for more information, something that they want to know about.

Second, you supply them with the information that they need or want to decide if they want to continue and take the next action and buy the product, or in the case of health care, go to the physician. This information also begins to manage expectations, and it is only through management of expectations that you can develop the satisfaction.

The chain continues in the third step, where you begin to develop a relationship that builds from the satisfaction you have developed based on information and that you can then develop over time.

Now, with the consumer efforts, success was easy to measure. Consumers voted with their dollars. They told you if the ad was right, if they liked the color, if they liked the layout, what kind of language they liked to see and hear, and you were able to learn how much information and what information to give at each step in the process.

This type of marketing effort also allowed you to target the information directly to those people who needed it. You were able to listen to people as they talked back to you and determine what their information needs were, allowing you to segment your audience and deliver the most effective information clearly to them.

Now, in health care, direct response-driven direct-to-consumer efforts of today attempt to do the same thing. What they want to do is get the right information to the right people, which will also help drive the cost of the marketing effort down. Now, to get consumers to respond with action is still the ultimate goal. To use the analogy of yesterday's testimony, it wants to get consumers into the game. But too often, the rules and, in fact, the referees have complicated that process, making the delivery of the information and the true message and the whole process a bit unruly, costly, and, quite frankly to the consumer, very confusing.

Advertising is necessary here because third-party education efforts and all the best public relations efforts simply cannot reach everyone, and advertising in this process is necessary to complete the dissemination of information to the entire public.

Current FDA oversight and micromanagement often prevents the most effective delivery of much of the information that is most relevant to consumers, especially the real emotional and psychological benefits that go along with product explanation. These are the things that consumers want and need in order to manage their expectations about diagnosis and treatment with any drug and in order to take the appropriate action.

While there is a science to marketing and direct response communications, the non-communication scientific background of the agency puts it at somewhat of a disadvantage, especially as new technology creates more information outlets which can allow the consumer to seek information wherever they want and quite possibly outside the management of the FDA or any truly legitimate provider.

MS. BOROW: We just heard a little earlier about the Internet, right now on the Internet, consumers are actually creating their own consumer-to-consumer health information networks that cover anything and everything--brand names, off-label use, alternative therapies, regardless of truth or validity, and they have access to all levels of clinical information from around the world through Medline.

In the future, while not every household may have a personal computer, and, in fact, the Internet may not be the panacea, I want to remind you that most U.S. households have more televisions than phones in them. When you take the use of the television and some of the technology that is making a television screen interactive, we will see consumers in their homes with the equipment to self-diagnose, have non-invasive clinical assessments and treatment plans developed for them right in front of some kind of touch screen.

Clearly, consumers themselves should not and cannot be regulated, but the agency should encourage responsible parties to guide consumers through this maze of information. It is for these reasons that we would like to suggest the following five actions for the agency.

First, yesterday, a colleague called for an impartial or unbiased panel. We would actually like to suggest one that is completely biased. What we mean is biased towards making DTC better, more effective, and more responsive to the real needs of today's and tomorrow's consumers. Direct-to-consumer advertising and communication is not going to go away. This panel would include representatives from the FDA, health care professionals, pharmaceutical manufacturers, markets, and consumer to review current DTC efforts for their good and their bad points and how they can adapt to the new more interactive media.

MR. SANDINO: Second, it was also yesterday proposed that there be a large survey of some sort or study to look at the effects of direct-to-consumer advertising on the consumer. Well, that may be somewhat moot. There already exists a great deal of very real quantifiable information. Rogaine, Proscar, Relafen, Cardizem, and several other efforts have generated millions of real consumer responses and real results. I think the FDA can and should ask the manufacturers and go out and visit and discuss with them to highlight their learnings, both good and bad, and then survey their respondents, with complete proprietary protection, of course.

MS. BOROW: To ensure the continued role and the strong role of the learned intermediary, the FDA should call on manufacturers to adopt a two-tiered or integrated approach for all DTC efforts, including physician pre-notice and education, as appropriate.

MR. SANDINO: The FDA can work with an advisory panel or with a research firm experienced in consumer benefit testing to clearly determine what benefits consumers really want, what benefits are truly important to them, and how they want those benefits expressed.

MS. BOROW: And finally, if the FDA would really like to be proactive and also have an opportunity to impact on its own image, we would encourage that serious thought be given to a one-year moratorium on all agency-specific DTC advertising guidelines relating to pre-clearance and brief summary requirements; that the agency put a comprehensive monitoring program in place and invoke the FTC-FCC standards for balance and truth in advertising, beginning three months from the completion of the public comment period. Thank you.


MS. PEDERSEN: Our next speaker will be Alicia Martinez from Giant Food Pharmacy Support Service.

MS. MARTINEZ : Good morning. My name is Alicia Martinez and I am a pharmacist. I am here representing Giant Food, Incorporated. My title is Manager of Pharmacy Support Services. Our organization does have a financial interest in direct-to-consumer advertising and we do receive financial support from outside organizations, but not a specific group.

First, I would like to address the issue of our relationship with the FDA. I am very grateful for our open and honest interchanges that we have had in the past. After all, the FDA panel probably shops at our Giant Pharmacies. We have had lengthy conversations, interchanging ideas and new concepts. This morning, I am going to share these issues with the rest of the group. My views are that of Giant Pharmacy. We have 400 pharmacists and we fill 14 million prescriptions a year.

Approximately five years ago, Giant began a program to include patient counseling information with every prescription filled. This information was limited and printed off of a dot matrix printer. We updated our technologies and we moved to laser printers, and now we currently give an expanded patient counseling information with new and refilled prescriptions.

Our patient counseling sheets include the brand name, the generic name, the pronunciations, the common uses, and here we only speak of approved indications, how to use this medication, cautions and possible side effects, and we receive this information from an outside vendor.

Many patients appreciate this valuable information. Some mail-order customers even come into our Giant Pharmacies and ask us for print-outs on our medications, but that is another topic.

At first, we had several complaints from physicians stating that the patients were asking too many questions because of these information sheets, but now the medical community has accepted the more knowledgeable patient.

We hope that in the near future, to enhance our patient counseling sheets, and we would like to include Spanish monographics, gender- and age-specific monographs, different levels of information, and also incorporating icons.

The reason that I am explaining these patient counseling sheets in such detail is that at the bottom of these brochures that go in every bag, we have blank spaces, and these blank spaces are considered prime real estate. We can print messages on the bottom of these brochures targeted to a specific NDC number. We have gotten approached by a multitude of manufacturers asking for advertisements on that.

Here are some of the proposals that we have heard. We have heard coupons for a refill on the same product, coupons for an adjunctive product. For example, if the prescription is for an antibiotic, then the coupon would be for a cough syrup to go along with it. An 800 number which would enroll patients with a certain disease state; an example is like all diabetics. Information targeted to a certain age or gender, like BPH message for men over 60 years old. We can even take this scheme a step further and incorporate food, so if it's a high-cholesterol medication, we can have a coupon for a low-fat cheese.

We have also gotten approached with the idea of doing doctor mailings, messages to change the dosage form from one form to another, mailings directly to consumers based on their profile information, price comparison with a competitor's product, and newspaper ads, and particularly disease awareness was the major focus there.

For a few of these, we have participated, but we have some very, very strict requirements at Giant and it has made it very difficult for us to go forward with any of these. With our list, for patient mailings, we have required a statement of sponsorship on the letter, a package insert if a drug is mentioned. The information has to have merit and offers benefit to the patient. Compliance to the medication and good will to customers. We only talk about approved indications.

The letter has to be coming from Giant and not from the manufacturer. The letter should be signed by Giant personnel. The letter refers to see your doctor for any questions. The pharmacists in the stores will be notified about the program so they are aware of what we are doing. And we are only mailing these letters out to adults.

So, as you can see, we have not been able to complete a lot of these requirements for these promotions.

In conclusion, I would just like to say that we would like to have our consumers well informed. We would like to have possibly some kind of less-stringent requirements. In today's integrated systems, both vertically and horizontally, working together is the key so that the consumers can make an educated decision. Thank you.

MS. PEDERSEN: Thank you.


Are there questions from the FDA Panel for any of the speakers? Yes?


MS. STIFANO: One question directed to Mr. Abdulezer or Mr. Schwab. This point was touched on in brief by Ms. Borow and Mr. Sandino. I agree, the Internet is a great source of information. The one question that I have, aside from the digitalized signature that would assure that the patient is getting some good, solid information is do you have any ideas on how the consumer would be able to discern that who they have connected up with is a truly viable source of information, if you would, and that they are not trying to promote or sell the latest magic potion?

MR. ABDULEZER: There are some very real issues regarding this matter. Most specifically, one of the, what I'll call dangers or pitfalls, is suppose someone has a legitimate source that's published on the Internet at a Web site. If another person wants to promote an additional product and also include a link to the legitimate site, they can do so, and to the consumer, it may be difficult to discern which entity is the right one and which one is the wrong one.

Say, for instance, a pharmaceutical company like Pfizer, Schering-Plough, or whatever has a Web site already established in their organization or a third-party company publishes it through some sanctioned vehicle. That doesn't stop anyone else from creating a Web site with a link to those pages and having a series of them and then also listing their own product.

There is a real problem here and there is no obvious way of getting around that, other than to have like a few well-known established locations, perhaps maybe there might be some form of certification or something like that that is acknowledged by a few specific designated--maybe the FDA can not so much approve the site but possibly acknowledge the legitimacy of certain locations or certain products or give the consumer the ability to check information from one single source and say, this is a product that is established, is properly licensed, has the appropriate approvals, and so on.

MS. BOROW: I think the FDA has a real opportunity here. One of the issues with the Internet is it really is a maze, and one of the ways to effectively use the Internet is to use other media to inform and educate. If the FDA wants to increase the positive image or build a positive image with consumers, one of the things that we could work on is using print and television to actually set parameters and guidelines for the consumer in terms of what they should be looking for as they cross the Internet.

We can learn a lot from, for example, the Good Housekeeping seal type of action, where people know that products with the Good Housekeeping seal have been reviewed. There is some way that, in fact, if the FDA wanted to, in terms of consumer information, you could use cross-media to advise people to go to certain sites or at least know what they should be looking for as they enter the Internet.

MR. SANDINO: Just to add to that, one of the difficulties that a legitimate manufacturer or provider of information faces is that they are under greater scrutiny than someone who is outside that legitimacy. So we need to relax the guidelines to make it possible for those people who are truly providing the real information to get it out to the right people, because otherwise, unmanaged communication will be delivering and it has the potential to deliver the wrong messages.

MR. ABDULEZER: I do have one more point I would like to mention, and a point which I think is equally important to what I will call the authenticity of the information is how current it is. I think there is going to be tremendous and significant importance of placing emphasis on keeping information current, accurate, and also providing a system of alerting patients who might be on some medication if the status is changed for some reason or there is some adverse event that is a serious one that has been identified and the patient population should be aware of it. There should be a mechanism in place to alert the appropriate people who may be tied in electronically to receiving that kind of information.

MS. BOROW: At this point, also, pre-clearance prevents that process from happening. The other issue I think we also have to keep in mind is the socio-economic levels of Internet users. Anything that is developed for the Internet today needs to be developed in another medium, as well. Otherwise, we are creating a real have and have-not society. I mean, we know that hypertensive juvenile diabetics reside in the inner city and may not have the financial means to be able to have access to the Internet, so that anything that is being developed for that service either needs to be put in public-type kiosks or in other medium.

MR. SCHWAB: Let me just make one last comment in this area, from our perspective, in any case. I think our thinking on the use of the Internet is as a global communications system, not something where an individual has to have a computer or have access to it. Our original thoughts in talking or speaking to the Internet was to create a repository or have somebody create a repository of information wherein there would be total availability by doctors, nurses, health care providers, educational institutions, whoever it might be.

Right now, one of the gaps that we see is there is no repository of patient information to go along with drug information. When an individual goes into a drug store, they get a patient information sheet such as Giant provides, but there is no disease state management information that is provided to the patient or is available to the patient on an ongoing basis, at least, not to our knowledge at this point, and this is the void that we see being filled by the Internet.

MS. BAYLOR-HENRY: If FDA were to delve into this area of Web site approvals, following up on your statement about the Good Housekeeping seal of approval type of thing, do you have any ideas about what standards the FDA would use in deciding which information was providing information that would be considered approvable?

MS. BOROW: I don't think it would be in terms of approvable. Then we're getting back to the old pre-clearance issue. I think it's format that you need to take a look at and that you need to recognize that the Internet is a communications tool and there are good ways and bad ways of using that communications tool. You can set some standards for how manufacturers can deliver their product-specific information in terms of risks and benefits so that there is a consistency in terms of the information that the consumers need, but I wouldn't want to see the FDA getting into the--we're going to get back into the same thing, of the pre-clearance of the specific message.

MR. SANDINO: And then that negates the large power and great flexibility of the Internet and you remove the ability of a manufacturer, for example, to refresh on a current basis the information that resides in the Internet, and that's the whole deal with the Internet. People go back to a site and look at it again and again because the information is new and current and there's always something new there. If it's old and static, which is what pre-clearance would kind of mandate, then people don't go back and visit it, so you reduce the effectiveness of that communication outlet.

MS. BAYLOR-HENRY: Is this somewhat of a quagmire anyhow, because once you get past into the first layer and you go into the linkages to your first layer, what you have there is something that you may not necessarily consider in the format that you had originally agreed upon, so it's almost not a controlled--

MS. BOROW: I think you can go as deep as you want with it. It's just like any other medium. I think the issue, though, is in terms of the consumer use. I mean, we keep talking about it's no different than any other direct marketing tool. You've got to acquire the user, you've got to retain the user. You want the user to come back. If it's so complicated once they go into the various levels, consumers are not going to go back.

We have the same issue with literacy on the Internet as we do in any other medium. What we need to do is help manufacturers get their messages out about the product, about the risks, and about the benefits as clearly as possible for it to maximize consumer usage and to make it as easy for manufacturers to be able to update that information when it's feasible, and right now, that's just too difficult.

I think, from a learning standpoint, the FDA can take an educational role in really helping manufacturers and other health care providers provide a system for the consumer to access information as easy as possible.

MS. BAYLOR-HENRY: I'm just curious. Do you have any information about how many consumers are currently using the Internet web to--

MS. BOROW: No. One of the difficulties for health care is their quote. The magic number is 30 million users. One of our pet peeves is there are 30 million Internet users, but let's look at what that population really means in terms of health care. If we were going to try to look at the whole population out of those 30 million and see who of those people that are on the system that have diabetes, have ulcerative colitis--in health care, we believe that the Internet is an investment that people need to make in terms of their communications vehicles, but it is not going to be right now and for probably the next 15 years the be-all or the end-all of communications, especially when you look at socio-economic criteria of the general population.

MS. PEDERSEN: Dr. Temple?

DR. TEMPLE: It is probably most useful now in treating pediatric diseases.

MS. BOROW: That's right.

DR. TEMPLE: That's who uses it. I can't get my kid off it.


DR. TEMPLE: I want to be clear I understand what you're urging. It seems odd to suggest that FDA's role is to help people figure out the format for communications. There are a lot of people who are already better at that than we are. Maybe you're not really suggesting that, but it sort of sounded like it.

If I understand it, you're saying that pre-clearance gets in the way and that what we should be doing is perhaps setting some kind of general standard but not try to pre-clear.

MS. BOROW: Right.

DR. TEMPLE: But I thought I heard you urging us to help manufacturers communicate the best possible way, and you're not suggesting that?

MS. BOROW: No. We're just saying that--

MR. SANDINO: There are just some standards. I mean, if people had general standards that they could go by and that you would stand by and that people would count on, it would be a lot easier for them to go forward.

And the fact is, take, for example, just telemarketing scripts for people who are calling in. You are listening to the phone call as a good marketer and the manufacturer or the agency, whoever is managing those calls, and you find out that there is a problem with the script, that people don't understand something. The technology is there to allow you to change that and ease the communication pathway immediately.

The problem is that most manufacturers are afraid to make the changes right away because they feel they have to go through pre-clearance. So by the time they get around to having that script changed and pre-cleared, and many times they don't even do it because it takes too much time and too much effort, the communication pathway is lost to the consumer and the confusion continues.

So if we had standards set up for not only the Internet but for many other of the interactive communications mediums, it would make things a lot easier, clarity could be delivered, and there would be much less confusion on the part of the consumer.

DR. TEMPLE: But the standards would be for sort of content balance, that kind of thing--

MR. SANDINO: Content balance.

DR. TEMPLE: --not format.


MR. SANDINO: One of the problems with the Internet that we see all the time is that even the manufacturers and the marketers who want to get onto it continue to overlook the fact that even though it's new technology and everything is great and far-edged and outer space with it, the fact is, it's still just another medium. And like any medium, you have to have clear objectives, crisp strategies, and a long-term perspective to make it work effectively.

MS. PEDERSEN: Dr. Woodcock?

DR. WOODCOCK: Yes. I have a question for Mr. Sandino. You said that, and this is just something I don't understand. I mean, I just don't understand it deeply enough, I think. What is delivered partly with direct-to-consumer advertising or whatever is emotional and psychological benefits that help manage expectations. Can you explain that in more detail?

MR. SANDINO: Surely. At least, I hope I can. What happens is too often people concentrate on product benefits. This medicine, and then they provide a list of statistics that says it's safer. Well, that product benefit may not relate to what the consumer really wants, which may be peace of mind. Peace of mind needs to be supported, of course, with the product benefit, and every claim needs to be supported and it has to be true, but there are emotional and psychological benefits that consumers look for to make them feel satisfied and good about a decision they are going to make.

Information relating to that is very important to helping them understand what action they would take and what action would be best for them. It also helps them understand when the physician speaks to them and indicates a certain medication why they should take it, how long they should take it, and the fact that they should follow their doctor's instructions.

So I feel very strongly that the understanding of those other benefits that go along with any product should be addressed because the consumer needs those.

DR. WOODCOCK: I still don't understand.


DR. WOODCOCK: Are the psychological benefits knowing more about your disease or knowing enough about the product that you understand the medium of exchange with your physician, or what kind of benefit--

MS. BOROW: The benefit varies for the consumer, and that's what we're saying.


MS. BOROW: I mean, somebody can talk about a particular product and talk about the product's benefits. What often happens now, because of the pre-clearance and the fair balance regulations, is that companies spend so much time on that that they don't have time in their message to really meet the consumer, where the consumer is in terms of the consumer's emotional and psychological needs.

If you're going to be able to tell somebody who has BPH that they're going to be able to sleep through the night and not wake up their spouse, that may be--there's no time in the ads right now because people are so focused on the specific product, fair balance, and benefits.

So what we're saying is that most effective advertising does what's called consumer benefit testing, tests with consumers in a qualitative sense. What are the benefits that they are looking for from a particular message? And that we feel that, again, to push people to action, you have to meet them where they are emotionally and psychologically, and if the action that we all want is for consumers to take more responsibility for their health care and to have a more actionable role with their physician, then we have to start to allow manufacturers to get at some of the psychological and emotional benefits. It may be confusing because we're using benefits and risks in both--

DR. WOODCOCK: I don't think it's confusing. I think it's sort of collision of the medical model with the advertising model--

MS. BOROW: Right, exactly.

DR. WOODCOCK: --and that's what I'm trying to get out here.

MS. BOROW: That's what we're saying. We're not talking about the medical benefits. We have to overlay the medical benefits with a communications benefit testing model.


MS. PEDERSEN: Ms. Baylor-Henry?

MS. BAYLOR-HENRY: For Mr. Schwab, your company has a health information home page, is that correct? Is that what you do, you set up these health information--

MR. SCHWAB: Yes, we have a site. We do have a site.

MS. BAYLOR-HENRY: Is that what you're primarily involved in?

MR. SCHWAB: We provide Internet services--no, that's not what our company is primarily involved in. We do other things, for instance, like we prepare computer-assisted new drug applications for some major pharmaceutical companies and we also provide Internet services for companies in general. One of the things that we do as part of the Web site that we have, for instance, at our location within our firm is we also provide some public service announcements, informational announcements, and other kinds of information that is helpful to the general public.

MS. BAYLOR-HENRY: On the Internet?

MR. SCHWAB: On the Internet, that's correct.

MS. BAYLOR-HENRY: Do you provide information on your home page on the Internet about disease state management and that kind of thing?

MR. SCHWAB: Not currently at this time.

MS. BAYLOR-HENRY: Would you care to share the type of information you provide on your home page?

MR. SCHWAB: Okay. We have several things on our home page. For instance, one portion of our home page describes various types of CANDA methodologies, computer-assisted new drug applications. Another one is we have an informational announcement service that we've created so that investigators who are going to be searching for or recruiting patients for clinical trials, information about those clinical trials are there and the information about where to contact the principal investigators at the various test centers.

There are also other services. You can have a Web museum of artwork collection on our Web site. We feel part of the nature of the Web environment is that it is a rich environment. It supports many kinds of information for many purposes. Therefore, it may not have a single focus or a single purpose in mind.

One of the things that makes a Web site effective in its use is the fact that people can find information rather serendipitously. They don't expect to see something, and yet there are other things that are relevant, and that's what keeps people looking. And that is perhaps why Dr. Temple's son is so addicted to his computer, because it's such a rich environment and it's continually growing.

MS. BAYLOR-HENRY: Thank you.

MS. PEDERSEN: Dr. Morris?

DR. MORRIS: I had a question for Ms. Martinez. You suggested that there are a number of promotional activities that you would like to engage in but you were not able to do this because of FDA restrictions. I wonder if you could be a bit more specific in some examples. You listed some activities, but what FDA restrictions would inhibit it in what way?

MS. MARTINEZ: Our number one blockage is the package insert, the printing of the package inserts right now, because we just feel it's just too much space. So like for advertising, we do advertising in the Washington Post and Baltimore Sun. It's just too much space.

Another type of media that we would like to get into eventually would be doing some kind of co-oping with the manufacturers, like even doing for TV, infomercials, whatever you want to call that kind of thing.

DR. MORRIS: So it's the same issues of the package insert and pre-clearance?

MS. MARTINEZ: Yes. It's all the same issue that we've been hearing the last few days.

DR. MORRIS: I also had a question for Ms. Borow and Mr. Sandino regarding the--actually, I do understand this with the benefit issues, but I don't understand the application. The FDA sees it kind of at the back end. We see an advertisement and we say, where's your substantiation? So let's say a company develops through qualitative testing the idea that there should be some patient benefits.

Are you suggesting the company then be free to promote their product on that benefit, or are you saying--because our first question is, okay, does the product actually do this? Is there substantiation for it? Are you suggesting that we not do that or we allow companies to do it more freely with less substantiation? I'm trying to figure that out.

MR. SANDINO: I don't think it's a question of substantiation. What we're saying is that certainly responsible marketing would say that you need to provide a consumer as full information as possible to make an intelligent decision on whether or not to take action. A lot of times, the relation, or the relating, let's say, the communication of the full information is left only to talk about product benefit, which doesn't allow a full explanation. So we're looking at trying to get the emotional and psychological benefits that would accompany any decision. We would like to be able to communicate and address those.

DR. MORRIS: So you are saying because there is limited time and space--

MR. SANDINO: Limited time and space, and there's so much mandated copy that you really can't get to that. You really can't tell the full story.

DR. MORRIS: So it's the elimination of the brief summary requirement and those requirements?

MR. SANDINO: Certainly.

DR. MORRIS: It's not the elimination of balance or truthfulness or some things--

MR. SANDINO: No, no, we're not looking for any of that because that would be irresponsible by the same token. If you go out and you're irresponsible with it and you promote something unfairly and you say it's going to make you the happiest person in the world and this is the best medicine ever to come down the pike and the consumer goes out and tries it and comes away dissatisfied, you have done a disservice both to them and it's also been irresponsible and it just doesn't make marketing sense for the manufacturer to employ that kind of a marketing technique.

MS. PEDERSEN: One quick question, Dr. Temple?

DR. TEMPLE: I thought Lou's summary of your answer wasn't the answer you gave. I understood you to be saying that you did, in fact, want to move into areas that were not necessarily studied and speculate to a degree on the psycho-social benefits that might occur.

You just said, well, of course, we wouldn't exaggerate it too much and say it's the best medicine in the world and will make you happy as a clam, but you might want to say, this will really--if you have BPH and you're kind of frustrated about the age implication and stuff, you'll feel a lot better with drug X, even if that hasn't been specifically studied. I mean, it might be true; it might be true. How far beyond the actual data are you thinking?

MS. BOROW: I think, again, we're getting confused with benefits of the product and benefits to the consumer to take action, and it may not be the benefit of the product specifically but it's being able to talk to the consumer about the emotional and psychological benefits of taking action and going to see their doctor. Right now, there's not space to actually focus on that because we're spending so much time focusing on the risk-benefit ratios of all the issues that have to be in terms of the product.

DR. TEMPLE: So a person with, say, a benign prostatic hypertrophy would be advised that if he went to talk to his physician about this, he'd really feel a lot better, something like that? I mean, I'm trying to figure out what the content is here. I don't know if that--

DR. WOODCOCK: I gather it might be more like you can perhaps have control over your waking up at night. Talk to your doctor. Is that what you're talking about?

MS. BOROW: Right, right.

DR. TEMPLE: Okay, and if that were true, then we would never have any problem with it. It may or may not be known, though.

MR. SANDINO: Well, part of that, though, comes from listening to the consumers and finding out the way they respond to it, and that's, I think, the gist of what we're trying to get to. There's much more that I think people need to appreciate about what a consumer responds to and the way they want to act and what kind of information they need, and I guess what we're trying to suggest here at the core of it is that we want and we would like you to listen with us as we go out and market to consumers and hear what they really respond to and hear what they really want.

DR. TEMPLE: I guess the only other comment I would make, that probably would encourage, if sponsors knew that, it would probably encourage them to do something other than measure urinary output and bladder retention and focus on the things that consumers really want to know, which is how often I have to get up. That has not always been done, although there is clearly a trend toward that, as everybody knows.

MS. BOROW: And I think we can take lessons from general consumer marketing, that if you start talking--I mean, there is that bounds. When car manufacturers, they are getting more information-specific. People are not just looking for the fluff. But we have almost, in the health care industry, we have gone the other direction. We don't really communicate on a person-to-person, individualized basis because we have had to be so focused on the specific product benefit and risk rather than the emotional and psychological benefits to the person of taking some kind of health action.

MS. PEDERSEN: Thank you. I think we have one last question from the floor, which I would encourage the panel to address very briefly, but I think it's important that we get it out here.

DR. OSTROVE: It's especially appropriate for this panel. The question was, will the transcript and associated speakers' materials from this hearing be available over the Internet.


MS. BOROW: Do you want us to help you make it happen?

DR. OSTROVE: Well, the FDA has its own Home Page and we have certainly received this request in the past and we are looking into it. Whether it will actually happen for this particular hearing, I couldn't say, but the question was for the panel, as well.

MR. ABDULEZER: I spoke to Dr. Zwanziger earlier this morning requesting if that transcript could be made available, because we would be happy to publish that on our site.

DR. OSTROVE: That's good to know.

MS. PEDERSEN: The transcript will be available within two weeks.

MR. ABDULEZER: Excellent. Then you will have it in two-and-a-half weeks on the Internet.

DR. OSTROVE: And you'll have your materials out there, also.

MR. ABDULEZER: Well, of course.


MS. PEDERSEN: Thank you very much to all members of the panel.


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