• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

Transcript of Direct-to-Consumer Promotion Public Hearing: Public Comments


FDA Public Hearing

Direct-to-Consumer Promotion

Thursday, October 19, 1995

8:40 a.m.

Quality Hotel
3727 Colesville Road
Silver Spring, Maryland





DR. PEDERSEN:  We have now reached the public comment portion of our hearing and two people have requested time to speak, Dr. Arthur Hayes and Joe Davis. I would ask them to come up, because I think it's easier for everybody if the speakers come to the table.

I would also ask professor Jean-Pierre Bader, who is here from France, if he would join the speakers at the table so that he could answer a few questions for us with respect to how France approaches the issues that we have been discussing.

I would ask each of the speakers, first Dr. Hayes, then Mr. Davis, and then we will have a few questions for Mr. Bader, I would ask each to identify themselves and I would hope that five minutes would be enough.


DR. HAYES : Thank you very much. My name is Arthur Hill Hayes and I am the President and sole employee of Mediscience Associates, which is a consulting group. I do work with regulated industry. Today, I am here representing myself and paying my expenses.

I don't come with any long statement. Indeed, I think 60 seconds will more than suffice.

But after hearing yesterday's comments and reinforced by a focus of one of the earlier panels, it relates to the Internet. Contrary to what we heard, I am persuaded from things I have seen that Internet in producing promotional materials for drugs and biologics is using graphics and sound very liberally, and I must say to my very inexperienced marketing eye, very effectively. This is in the works. I mean, I've seen such programs.

It seems to me that there are a couple of issues before the agency, and I raise it and perhaps Dr. Temple or others would like to comment on it.

Number one, there's a lot that goes on in Internet that relates to otherwise FDA-regulated products and companies that is not, at least in my judgment, part of FDA's purview. That which otherwise would be the same as a conversation between two individuals on the Metro platform in the morning about a drug or an ad or a scientific dialogue or discussion that is divorced from any regulated industry sponsorship, although those are areas that have at least a large gray perimeter.

But in the areas about straight marketing, promotion, advertising, it seems to me that the agency has to address, and I believe ought to do it in an active or even proactive way, about what indeed is part of FDA's responsibility and how can they get about regulating it with a small "r"--I'm not suggesting immediately going to the CFR--and working with outside groups where there is an expertise that I think could be helpful to FDA.

That relates to the second part of my comment. You heard me quoted during a speech I gave whilst I was Commissioner saying that one of the essential hallmarks of any regulation of DTC involves enforceability. It seems to me that the agency must, and I'm sure already is, addressing, one, how do we find out what's going on out there so that we have some idea of the definition of the universe and what part of it is our responsibility?

And secondly, how do we enforce that which we do? How do we monitor compliance? How do we know, short of whistleblowers, which I think as a sole means of triggering enforcement is inadequate, how do we know what's going on out there that we believe violates a regulation, a policy, common sense, good science, appropriate medicine, patients' rights, and all the other things we've heard about?

I would be interested in any comments that those from the agency might have about looking at what we heard today is a complex and rapidly-growing Internet world. Thank you.

MS. PEDERSEN: Thank you, Dr. Hayes.


Mr. Davis?

MR. DAVIS: Thank you very much. My name is Joe Davis. I am with the Newspaper Association of America and its subsidiary, the Newspaper National Network. My trip was paid for by the Newspaper Association.

Previous to being on the media side, I was in the agency direct-to-consumer development since the early 1980s and was very involved on the agency side, as some people know, with the Seldane campaign and Nicorette and, more recently, Proscar, so I have that agency background.

But I am now looking at things from a media standpoint and I would like to bring a couple of studies to your attention, some data that may be helpful as you consider a small part of this total issue, which is the media question of broadcast versus print. These are the traditional media. We have heard a lot about the new media, and that is certainly an exciting perspective, but we do have major current media and those are what is going on today.

The first study was reported in the Wall Street Journal. I bring it to your attention and would like to enter it into the record. It was published on June 6, 1995, in the Wall Street Journal and it says, the headline is, "Consumers Prefer Print Ads, Study Says". The study was conducted among 2,000 consumers by the Video Story Board Test Company, which measures the popularity of various advertisements and is followed by the industry rather carefully. It's been going on for some years.

A major change seems to have taken place, in that consumers prefer print ads. We all know about the popularity of television, so this was a bit of a remarkable finding. The reasons they prefer it are quite logical and common-sensical. Print ads are more informative, less intrusive, less jarring. In a sense, they're interactive because one can pick up or put down a print ad. It doesn't force itself on your attention.

Quite surprisingly, consumers in this 2,000-person study also found print ads to be more entertaining. That was sort of surprising and more enjoyable. I will leave this full article with you. it is, I am sure, a change.

My hunch is, for whatever that's worth, is that this is a reflection of the aging of the boomer population. Seventy-six million post-war children and now growing into their middle ages are getting more interested in health care, financial future, savings, annuities, and all those kinds of information-driven subjects. As they become more interested in these areas, they are going to print more and more because print and news and the newspaper, I might add, is an informational medium.

The second piece of research is also syndicated large-scale research on the subject--we sometimes are left with the impression that broadcast is the only way to reach mass America, and I know you have that on your minds, I believe. That's true, but here, obviously, I'm speaking from a personal perspective and biased perspective, I guess now, working for the Association, but the facts are there.

Sixty-two percent of the American adult public read a newspaper every day. That's over 150 million Americans. That is equal to a Super Bowl every day. There are over 1,000 daily newspapers and hundreds and hundreds of weekly community newspapers that produce this. So any advertiser who wants to reach 62 percent of the American public in 48 hours can do it. We can get them there.

Over four insertions, four times, this will reach over 80 percent of the adult American public. Basically everybody who reads is involved with the print medium and the newspaper medium, and with that, I'll conclude.

MS. PEDERSEN: Thank you. Are there questions from the panel? Ms. Bernstein?



DR. BERNSTEIN: This question is for Dr. Hayes. You posed a question to the panel what FDA is doing. Actually, I would like to turn it around back to you. The Internet is something that we're looking at and struggling with and cyberspace is huge. With what we've heard, you can link everywhere and jump and move around.

You asked us what we're going to do about it and I was just wondering if you think that, given this broad universe, are there truly ways that FDA can find and see exactly what's going on out there without having our entire Office of Compliance sitting at computers surfing the Net all day?

DR. HAYES: I think you get right to the heart of the question, if you want. It seems to me, and I have to be honest, I am, A, no expert in Internet or Web pages and the like and I haven't thought this through, if that's possible.

But it seems to me that there is an opportunity in the near term, but in an ongoing manner, for the agency to seek out, look for volunteers, a little bit of both, perhaps, groups that are expert in this and to sit down and talk dialogue about ways, A, ways to approach this, so that both the agency knows what's going on out there firsthand, if you want, what are the capabilities, so you can begin to put, if not a fence, at least a boundary around it from FDA's perspective, and secondly, to see if there is an appropriate way for those outside the agency to provide the brains and the eyes and the fingers to surf through the network, if you want, to help to monitor what's going on.

I'm not suggesting just hiring a firm to do monitoring, and I probably don't know enough about it to even know what the possibilities are, but it just seems to me some dialogue between the agency and those that, at least in my brief experience, seem to know an awful lot about this and be able to create incredible pieces of promotion with sound and music and lights and graphics, and what we heard earlier, that graphics get a lot of attention. Believe me, the things I saw will get a lot of attention.

I think FDA ought to know what those capabilities are and then see what is the best way, without chewing up all of the agency's resources, to monitor what's going on.

MS. PEDERSEN: I think Dr. Morris has a question for Professor Bader from France.

DR. MORRIS: I'd ask Dr. Bader to speak to the Panel and simply to talk to the issue of what is the status of direct-to-consumer promotion in France or in Europe and to make some comments on how it might be perceived in those countries.


DR. BADER: Thank you very much for the opportunity to talk. My name is Jean-Pierre Bader, B-a-d-e-r. I am a faculty member in Paris, a gastroenterologist. For four years, I am the Chairman of the Advertising Control Committee in the Drug Agency in Paris.

Our regulation in France, and it is the same in Europe in the European unit, are very different of yours, as you know, because, for example, advertising about the prescription drugs, the direct-to-consumers that is the title of your hearing, is strictly forbidden in Europe from the French law and the French Directive of Brussels. The only way for the firms to communicate with the consumers is the package inserts, which is strictly controlled by the agency, and conform with indication of authorization to market.

It is a difficult position, because it is, for example, difficult for us to control the curiosity of the journalist. As you have, for example, new innovative, very innovative drugs, as Prozac, as Tacrin, all the newspapers, all the journalists of TV and the broadcasting system are talking about these drugs and we are hunting with firms, are you responsible of this talk, of this TV appearance, of this paper in the journals and what. It is very difficult. You are controlling and talking with the firms and they told us, no, we are not responsible.

For example, about the Prozac with many, many books edited in France and I am in charge of talk with the firm. Are you responsible of the edition of this paper or of this book, and they told me, no, no responsibilities. It is not marketing. It is not advertising. It is only the curiosity of the people. It is a difficult gray area.

Another problem is, for example, I heard this morning about all the definition, what is education, what is information, what is advertising and was a confused system about all these concepts. For example, we now have a problem to educate people about--I talked to the Chairman this morning about the education of people about, for example, the treatment, post-menopausal hormonal treatment. We estimate that in France, we guess, for example, that in France, too few women are treated by this way. It is under-treatment, not over-treatment, under-treatment, and with some public interest to investigate and to push and to make pressure on the people to accept this, to be volunteering for this treatment.

Recently, for the first time, we authorized a firm to make a campaign, television campaign, about this problem and to say to a woman, it is a useful treatment and it is in your interest to have this treatment and ask to a doctor. No drug, no hormone indication and only the name of the firm that was paying for this television campaign. I think it is a new initiative. It is like a break in the system of strict and definitely forbidden of don't talk to the patients.

In another way, advertising is authorized for OTC drugs, but we have in this way an a priori control of all the messages delivered in newspapers, in TV, and in broadcasting. WE deliver an a priori control of all the messages.

Our problem, and it is our understanding and it is also yours, is how to control the message diffused by worldwide systems such as Internet and as satellite television. It is crossing the frontier, and we have not the same regulation in the United States and in Europe, for example. By CNN, it is possible to receive advertising for drugs which is forbidden in France. What would be our policy this way, because it is a real problem. Thank you very much.

MS. PEDERSEN: Thank you, Professor Bader.

Are there other questions for the panel? Dr. Temple?

DR. TEMPLE: I wanted to partly respond to the question Art Hayes asked. Coping with the wide range of places that data can show up is obviously very hard. We're not going to trace--we're not going to spend all our time surfing and tracing and things like that. I'm not sure what the answer is to that except that we are capable of asking companies to report on what they're doing and let us know.

But I guess I would say--I hope this isn't just because I'm not the under-18 generation--I think the content aspects of it are more traditional than one might imagine. We regularly see, for example, in looking at an ad campaign, a whole series of things that make a few points but in different ways. One you slip into your wallet. Another one is the basis for print ad. Another might be another thing.

But the crucial bar charts and the crucial themes are really very much the same and it seems to me that whether you create an interactive program in which you answer certain questions in certain ways, you're still displaying the same kinds of data that we're familiar with. You're just using different ways to display it.

I don't think it's unusually difficult necessarily to set standards, or pre-review or whatever we end up with, those things in much the same way we did before. Their distribution is going to be unimaginably different in all probability, but the guts of the content--somebody has to sit down and write it just like they always did, I think. So I'm not sure how totally different the ballgame is, because in the end, there's a message and someone's written it.

MR. HAYES: If I could just say a word, the materials that I've seen so far are exactly as you say. In fact, they are, in terms of content, incredibly conservative. I mean, it may have volcanoes going off and whatnot but the message is conservative. I think at least part of that is that the ones I've seen have been underwritten by firms that, at least in my experience, are reputable, credible, intelligent, and certainly don't want to get in trouble with the agency over something like this, besides which they are still experimenting mostly at the medium and the graphics and sound and distribution and the like.

I guess my question, and I can't really say it's a concern because I don't know enough about it or haven't been involved in this long enough with clients or friends or what not, is what might happen because of the complexity of the system, what, in fact, might happen besides what is traditional.

For example, I know for a fact, as I'm sure most in this room do, that one can on the Internet find out about the availability, even down to a street address or a phone number, of a lot of AIDS drugs and anti-cancer drugs, most of which do not have approved NDAs or PLAs. But I have seen a couple of things that, while I cannot prove that they were sponsored by someone over which FDA does have responsibility, I was very suspicious. I am not trying to make a mountain out of a molehill and I think you know me well enough that I am not just looking to, let's write some regulations, have a new policy, and send compliance officers out.

It just seems to me that it's a great opportunity for the agency to be ahead of this, to use the jargon, even if it is, as you just did say, a good bit of this in terms of the source of information as against the mode, is traditional and we know how to keep track of that.

But at least for companies that have come to me and said, what are the rules--one gave me, just for my interest, in the mail--I haven't even talked to them--32 questions that maybe I would bring up today, and I thought that Ms. Pedersen might not want to go through the afternoon and into the night. But they are very detailed questions. I don't even understand some of them, quite honestly, but I think that the agency is going to have to address them.;

DR. TEMPLE: The compliance aspects are formidable and challenging. I wasn't trying to address those. I don't have a clue. But, I mean, some of the content things are at least moderately familiar to us, I would have thought.

MS. PEDERSEN: Ms. Stifano, and then a final question from Dr. Morris.

MS. STIFANO: This is Dr. Bader. Aside from the recent broadcast to reach women who are post-menopausal and needing hormonal treatment, what other means do patients have of getting information aside from the package insert from their physician? What other means are available to them?

DR. BADER: Your question is about what I was telling about post-menopausal treatment, yes, but it is possible to--this campaign will be we have now the possibility to improve your status and your health in the post-menopausal condition. We have new possibility to do that. Ask to a doctor and the doctor will discuss with the patient and give some drug, the drug of your choice, of his choice, and the patient will have in the package the insert giving information, completing the information of the doctor, the information of the pharmacist.

I did tell about that, that it is also possible to buy a dictionary. We are promoting now in France the system to sell a medicine dictionary, a medicine dictionary as a PDR for the consumer. It is a good success. It is a possibility for the patient on a very objective basis, because these dictionaries are reviewed by the agency to have main information, most information about the drugs.

MS. STIFANO: Thank you.

DR. BADER: But it is a problem of objectivity of the information. I was a little bit disturbed. I heard this morning people in the panel comparing the advertising of a drug with advertising information about new cars, about other things. It is fundamentally different, because if you buy a car, you will be aware very quickly if information was exact, was correct or not. If you buy a medicine, you have no possibility to judge except for some side effects if it is true, if it is not true.

But about the efficiency of the drugs, all the things here, all the people here are very knowing very well that the efficiency of a drug is very difficult to make a judgment about. It is not possible to compare the advertising of the cars and the advertising of the drugs, it is my opinion.

MS. STIFANO: Thank you.

MS. PEDERSEN: Dr. Morris?

DR. MORRIS: I have a question for Dr. Hayes. Dr. Hayes, it was under your tenure as Commissioner that we first started to see direct-to-consumer advertising and you instituted a moratorium to learn more about it. I would be very interested in getting your perspective on what have we learned in the years since then. There were a lot of concerns, a lot of promises back then. What have we learned? What have been the surprises? What did you think might have occurred that did and didn't occur?

DR. HAYES: Oh my. Well, I can tell you that I think I expected to see more. I really think I thought from the interest that was brought to the 14th floor in Rockville by various firms that while some, as you know, were adamantly against it, wanted it to go away and would only engage in it if put into a competitive mode with the medium, but I think I thought there would be more of it.

And I must confess, and perhaps you have found this, in talking with various drug firms and advertising agencies and marketers and what not and asking them, why isn't there more, one of the questions is that they or their pharmaceutical firm clients are concerned and they're afraid of the 500-pound gorilla.

So as I said earlier, they are being conservative and careful. There have been certainly some instances where that's not the case, but I think that they are walking gingerly, or have. I think we will continue to see more.

The other thing, quite frankly, is, and I've been told this, that a number of companies and others aren't really quite sure what the rules are. You say, well, all they have to do is call or what not, but I mean in terms of any application or even alteration of the general rules that traditionally have applied to physicians and then expanded to other health care providers and prescribers, how they would apply in some of the things we heard yesterday and today, so that what you're doing is not a sham, that you are not following the spirit of the rule or the policy--I mean, the letter and not the spirit of it.

So I think that that's at least part of the explanation, and I'm also interested, as I have said, in whether computers are going to, through Internet and other formats, are going to step in where sponsors felt that television was too expensive to do the whole job, the very things we talked about 12 or 14 years ago.

I think the professor's comment about going across borders is very interesting. At least, my cable in New Rochelle doesn't have French, Belgian, Taiwanese, or Australian television, but I suspect that day is not too far away, and if there is a country that has rules different from ours, as ours from France's, or the other way around, then what's going to happen if I tune in, let's just say, an Australian broadcast or even an offshore English language broadcast and they are saying things that send the agency into orbit, as it should?

MS. PEDERSEN: Thank you, Dr. Hayes. I would like to say, you are correct that we probably would not have been able to manage your 32 questions this morning but we would be very interested in seeing them if you would be willing to submit them to the record.

DR. HAYES: I will submit them to the record.

MS. PEDERSEN: Thank you very much.

Let me thank Dr. Hayes and Mr. Davis and Professor Bader for their contribution.