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Transcript of Direct-to-Consumer Promotion Public Hearing - Panel 6

PANEL 6 PARTICIPANTS

 

 

 

PANEL 6 PROCEEDINGS

MS. PEDERSEN: The next panel will be Panel 6: Jeffry Perlman, Matthew Seymour, and Peter Seaver.
Mr. Perlman?
MR. PERLMAN: Good afternoon. I am Jeff Perlman with the American Advertising Federation here in Washington, D.C. I am expressing the views of my association. My association membership includes advertisers, advertising agencies, media, and 40,000 to 50,000 individuals engaged in the advertising industry across the country. We are, if you will, the umbrella organization for the advertising industry, and, of course, many of my members either advertise, have the advertising included in their publications, or would like to have the advertising included in their publication.
MS. PEDERSEN: Thank you.
MR. PERLMAN: Speaking today toward the end of this hearing and as the third advertising association to speak in a row, I am pleased but not surprised to say that I am supporting a great deal of what has already been said and much of what has been said recently. But before speaking specifically about prescription drug advertising, I think it is worthwhile to emphasize the positive effects advertising has for consumers and for the economy.
Commercial speech is important to manufacturers and consumers as well, and to repeat what has just been said a few minutes ago, in fact, the Supreme Court in the landmark Virginia Pharmacy case extended the First Amendment to commercial speech, a case which involved price advertising for prescription drugs. And to repeat the quote, it stated that "A consumer's interest in commercial information may be as keen, if not keener by far, than his interest in the day's most urgent political debate." I suspect that shows you how attuned one advertising association is to the other. We share common goals.
Advertising provides consumers with critical basic information about a product or service. It provides a springboard for new products and encourages innovation. Advertising is the most efficient way, we believe, to inform consumers of new products and product improvements.
Advertising lowers consumer prices. That fact was shown when the Federal Trade Commission compared the price of eyeglasses in states that permit advertising to the price in states that did not. The results were that where there is advertising, the quality of the product remained just as high, but the price went down. We would note that eyeglasses, like pharmaceuticals, are available after medical consultation.
Advertising helps fund minority points of view as expressed in specialized publications in national and local markets. Many of these publications go to hard-to-reach audiences who would particularly benefit from advertising. We believe that prescription drug advertising will provide these benefits to consumers as well.
The FDA, we believe, should exploit the public health advantages advertising offers; however, efforts to force advertising to play roles for which it is not properly suited negate these advantages. Advertising is not labeling. Advertising quickly and succinctly provides consumers with useful information about the availability of products or the drugs to treat illnesses. Pharmaceutical advertising will encourage, we believe, consumers to consult a physician about whether the product is appropriate for his or her condition.
There is a need to emphasize that, unlike most advertising, as others have emphasized before me, consumers cannot simply act on their own, but they require a doctor's prescription. We also agree with Professor Rubin who has enunciated many of the very important and unique advantages pharmaceutical advertising offers consumers. For example, if the patient does not have regular checkups, advertising can be the medium by which he or she learns that the condition is now treatable or treatable in a different fashion.
Or consider, for instance, how the public learned the basic benefits of a high-fiber diet. Despite the best educational efforts of the government and medical establishment, public awareness remained very low. However, when certain companies made the decision to provide truthful, non-deceptive, and limited scientific information in understandable form in product advertising, public awareness skyrocketed. Of particular importance is the fact that the knowledge increase was greatest among the poor and well educated, and, of course, this is documented in the FTC study, Health Claims in Advertising and Labeling, a study of the cereal market.
For example, for women, the greatest increase in consumption of fiber cereals from 5.9 percent to 16.1 percent occurred among those in the lowest educational group. We believe this scenario could be repeated in the pharmaceutical industry as well.
We also believe that advertising is the most efficient way to reach patients in these and similar situations. The FDA has neither the resources nor the expertise to so effectively educate the public about pharmaceutical products. And as with fiber, the information is likely to be particularly beneficial to those most unlikely to regularly visit a doctor.
In addition to educating patients currently afflicted with a condition, the information in the advertising may well raise the level of medical knowledge through society at large. Thus, it promotes awareness of potential health problems, thereby, we think, increasing the likelihood of early recognition of disease.
Well, if there are advantages to advertising, what about the perceived disadvantages? Let me just raise a few of those discussed concerns.
Possible harm to the doctor-patient relationship has been mentioned. To quote Dr. Jay Sewick in a recent Washington Post article, "Providing written information may intimidate or alarm some people, but I think the risks of not providing information are far greater. And if providing the information prompts more discussions between patients and their doctor and their pharmacist, then I would consider that a step in the right direction."
The public benefits from more information recognized by the doctor pertain directly to advertising. Evidence from the eyeglass study demonstrates that advertising lowers price. There is every reason to believe that this benefit would eventually find its way to pharmaceuticals, especially where there is competition.
As for another concern, too much or intimidating information, we believe a reasonable FDA policy would put basic, easily understandable information into the patient's hands. He or she is then more likely to be able to intelligently discuss the condition with the physician and become part of his or her own treatment team.
Now, like earlier speakers, and as part of the advertising industry, we are particularly concerned that FDA policies do not appear to recognize the First Amendment value of constitutionally protected commercial speech. The Founding Fathers recognized the value of information to consumers. The examples of how ads can reach consumers which I cited earlier we believe demonstrate what the Founding Fathers had in mind.
In considering this issue, you cannot disregard the First Amendment. We believe the FDA restrictions on advertising eventually will not pass constitutional muster. And in Central Hudson v. New York, the U.S. Supreme Court established the test the government must pass before regulating commercial speech of a legal product. Simply stated, as others have, the regulation must be narrowly tailored and directly advance a substantial government interest. Again, we believe that FDA policy presently cannot pass that test.
Current FDA policy holds an ad to be misleading or false if it does not contain an extensive brief summary. Obviously, these brief summaries are anything but. We would refer you to the FTC. The FTC, in developing the national standards for advertising law, only requires disclosed information in an ad that is needed to qualify actual claims made. Consumers under this policy would obtain further information from the label package inserts or from their physicians. This distinction between advertising and labeling, we believe, is recognized by the First Amendment protection of commercial speech.
A true and positive statement about a product, such as you find in a conventional advertisement, is not misleading because all negative attributes are not mentioned as well. This attempt to rewrite the dictionary with the FDA's unique definition of false and misleading again, we believe, cannot pass constitutional muster. No substantial government interest is served by requiring the existing brief summary as it is defined in advertising.
The information is available from the physician who must prescribe the drug, the pharmacist who provides the drug, and the packaging and labeling of the drug. Nothing, we believe, is gained by requiring it in advertising as well. In fact, all the information inhibits the advertisement from effectively playing its role of attracting the consumer's attention to the presence of a new or improved drug.
Finally, the regulations are not narrowly tailored. The brief summaries are so extensive as to effectively ban advertising on radio and television, and print advertising becomes substantially more expensive when more space must be purchased to provide the summary. Many are so long as to make the print advertising prohibitively expensive as well.
We urge the FDA to reconsider its advertising practices in light of the constitutional protection offered commercial speech.
The bottom line is direct-to-consumer advertising is here to stay. The FDA should work to make it as effective as possible so that consumers have access to truthful and valuable information. People are increasingly demanding full information about the goods and services they purchase. These demands apply equally to their health care. People recognize that treatments have different results, side effects, prognoses, and that treatments and drugs are changing regularly.
This information becomes more important as the health-care system changes and patients assume more responsibility for their health. The information becomes more useful as individuals are picking up more and more of their health-care costs. And information, good or bad, is becoming more and more available through consumer-to-consumer communications, as, for example, through the Internet.
We endorse a number of proposals already offered which we believe will alleviate some of the problems. The fact that the FDA controls introduction and distribution of drugs could have a chilling effect on a manufacturer's willingness to speak and challenge policy. Even where control over drug introduction and advertising is completely separated within the FDA, the appearance of intimidation and impropriety might well remain. This result serves no purpose. Control over advertising and marketing we believe should rest with the FTC. The FTC has decades of experience evaluating advertising and how consumers understand it.
In conclusion, the FDA has a noble purpose in protecting health, but in our opinion, its views on advertising of prescription drugs fails to recognize that ads work to empower people to promote their own health.
Thank you.
MS. PEDERSEN: Thank you very much, Mr. Perlman.

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Mr. Seymour?
MR. SEYMOUR : Good afternoon. I am Matthew Seymour. I am the president and chief executive officer of a company called Common Health Direct. I am appearing on behalf of not only Common Health Direct, but our parent company, Common Health USA. Common Health USA paid for my travel expenses for participating today.
Additionally, we are engaged in activities that contribute to the promotion of prescription drugs, biologics, and devices. Specifically, Common Health USA is an alliance of ten health-care companies, marketing and communication companies that comprise the largest resource of its kind in the world.
Now, as a point of reference that might be a little more close to our situation today, one of our companies created the advertising that caused Dr. Zito so much consternation. But, thankfully, that was approved by the FDA.
Common Health USA is the partnership of the Ferguson Communications Group which is the largest full-service pharmaceutical agency in the nation, and the HLS Corporation, the nation's most experienced health-care education and managed-care marketing company.
Educating professionals and consumers about health-care options is one of the main focuses of our business, and that is why we are showing such great interest in this proceeding today. At Common Health, we believe the dissemination of accurate information allows our citizens to take a proactive role in the maintenance of their own well-being by enabling them to make educated health-care choices.
We have convincing, though largely anecdotal, evidence to support our conviction that people benefit from exposure to clear, concise, and truthful direct-to-consumer health-care information. In agreement with the FDA's hearing notice, we propose today that definitive research be conducted to quantify the effects of direct-to-consumer advertising, and we think this can be done in a timely manner.
Once an impartial group is formed to oversee the protocol design, it really need not take more than about four months to give us an indication as to the effect that direct advertising has on health care and consumers. Parenthetically, if we could within three to four weeks form an impartial advisory group, I believe that we could, prior to the completion of this hearing record on December 29th, have a protocol written for that study. So our invitation is let's get it done.
In the unlikely event that the research finds that there are areas of concern about direct-to-consumer advertising, then this agency can develop controls and monitor those areas with the agreement and cooperation of the entire advertising industry.
Until now, the health-care communications industry has been virtually silent regarding the effects of direct-to-consumer advertising and its benefits for preventative and remedial care. Yet we are all aware of the increasing amount of health-care advertising on television and radio, newspapers and magazines, even on billboards and on the sides of buses.
The simple fact is that the amount of direct-to-consumer advertising has mushroomed because people crave information about their health-care options. For example, a recent study by Louis Harris and associates found that Americans would prefer to exercise their own judgment in conjunction with advice from professionals when making health-care decisions, and they want to be more knowledgeable in order to make intelligent choices. It is hard to make wise choices without access to the facts.
For instance, a study conducted by Gallup organization and sponsored by AmGen, Inc. found that almost half of all cancer patients undergoing chemotherapy aren't even aware that there might be life-threatening side effects to their treatment. In this context, people have an overwhelmingly favorable response to direct-to-consumer advertising when it provides information that is available, clear, and concise.
Let me quote from a few letters we received following a direct mail campaign that Common Health ran for an infant formula. I quote:
"We appreciate your interest and your desire to continue to provide an excellent product. Our child has been extremely healthy, and that can be directly linked to the quality of your product."
Another parent wrote, "Thank you for the helpful information that I have received over the past months. I find it interesting, concise, and informative."
Finally, this one wrote, "It is rare to run into a company that displays such a genuine interest and understanding in their customers' needs." She added, "You know, it has to be really outstanding if a new mother would take time out to write a letter."
We have dozens of letters like these from people thanking us for the information we have provided to them. Almost all say that knowledge has empowered them to make more informed choices, because in addition to wanting more information, consumers tell us they want greater involvement in their treatments and more of a voice in the decisions that physicians and hospitals are now making on their behalf.
In the campaigns we have undertaken, Common Health USA is responding to the desire of the American people by providing them with useful and accurate information. We take this responsibility to our fellow citizens very seriously. We believe the requirements of direct-to-consumer health-care advertising are that it be clear, factual, and balanced.
Now, health-care choices are rarely black and white. Many decisions cannot properly be made by consumers without the advice and support of the physicians, just as physicians should not make health-care decisions for people without their informed input. Direct-to-consumer health-care advertising plays a critical role in building bridges between consumers, health-care providers, and the health-care system.
At Common Health USA, we create communications to facilitate dialogue among nurses, doctors, dentists, managed-care providers, and their consumers. We are familiar with the arguments both for and against direct-to-consumer advertising. It troubles us, however, that most of what parades as research is simply opinion--yes, well-reasoned opinion, but subjective nonetheless.
Now, in the interest of moving this issue forward, we believe it would be better to put opinions aside and try to quantify the effects of direct-to-consumer advertising. All of us, the ad agencies, pharmaceutical manufacturers, the medical profession, regulatory agencies, need to stop attacking the issue from our own subjective point of view. We need to start looking at it from the patient's perspective.
The critical question is: Do these communications help people take more responsibility for their own health care? This hypothesis needs to be tested with the people whose opinions and behaviors matter the most--the American health-care consumers.
Let an independent research firm chosen by this Federal agency create a study to investigate how direct-to-consumer health-care advertising actually affects a nationally projectable test group, a test group of consumers and their health-care advisers. Let's compare their attitudes and behaviors against a group that wasn't exposed to direct-to-consumer advertising. Then we will know for certain whether the impact of direct-to-consumer advertising is positive.
Please don't misunderstand our position concerning the value of opinions. All of the discussions to date have been valuable in isolating the germane issues this study would investigate. We also have a much better idea, as Deputy Commissioner Schultz said this morning, we would have a better idea after that research what elements of the current policy make sense and which don't.
What is exciting to us is that these issues appear to be very measurable. For example, compared to Americans who are not exposed to direct-to-consumer advertising, are those who are exposed to it more or less, A, abusive with their prescription drugs; B, compliant with their prescription therapy; C, actively engaged in healthy behaviors; D, satisfied with the information provided by their doctors; E, able to diagnose their conditions earlier; F, knowledgeable about the strengths and limitations of their prescription drugs?
Now, certainly there are other issues that need to be explored, and the studies should be developed with input from all the interested parties.
There are a number of leading companies and non-profit organizations that would be willing to cosponsor it, and Common Health USA will contribute to this solution in any manner you wish.
In closing, we propose measuring the effects of direct-to-consumer advertising objectively before further changes are made to either regulate it or streamline it. Any other action would be based largely on unsubstantiated opinions. Common Health USA is willing to assist in designing the study in cooperation with you and to serve as its coordinator, fund-raiser, or whatever would be most helpful towards reaching our common goal of providing better health-care information for all Americans. It need not take more than four months once a research group is chosen and the parameters of the study are defined.
Thank you for your time and interest in this important matter.
MS. PEDERSEN: Thank you, Mr. Seymour.

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Mr. Seaver?
MR. SEAVER : Thank you, Madam Chairman. My name is Peter Seaver. I am here from Kalamazoo, Michigan. I am a full-time employee of The Upjohn Company. I am here on company business today, and we have a great deal at stake in terms of the regulations about direct-to-consumer advertising. We have had some opportunities in my company over the last several years to learn, along with our colleagues in the FDA, about how to approach this, we think in a responsible manner, and it is a privilege for me to be here today.
My remarks today will focus on creating a proper context for direct-to-consumer promotion of prescription pharmaceuticals rather than commenting on the nuances of regulation in this area. As we have seen this morning, we have many experts in the field of the nuances, but I would like to share some of Upjohn's thinking about major themes and possibly focus more on just the advertising component of that a little bit later.
I would like to discuss what has changed since the early 1980s when this issue first came up, because I think a lot of things have changed, and I would like to take a look at, over the last 11 years since we last addressed this officially, what hasn't changed.
The biggest changes are in the health-care system itself and growth of information technology all around us. It is, indeed, a whole new ball game. If we think back to 1984, we see that capitation was relatively new, and the managed-care concept was just really getting off the ground. Today the concept is growing to the point where we anticipate 75 percent of all Americans will be in some form of managed care by 2000. I think that is a conservative estimate.
Our health-care system is no longer centered on fee-for-service physicians. This does not mean, however, that physicians are out of the loop. It means that patients are more in the mix. Responsible consumerism in managed care and integrated health-care systems requires patients to take a more informed and active role in their own health care. We believe direct-to-consumer promotion holds the promise of helping people make better informed decisions when they visit their doctors.
Another big change in health care is the number of significant prescription medications that are now going over the counter. Pepcid and Tagamet just went on the OTC market, and Nicorette is likely to follow, and I am sure there will be others. These medications and others in their classes were the subject of a lot of direct-to-consumer promotion when they were prescription only. Consumers are more familiar with them now because of the range of information that they received. Direct-to-consumer advertising and other forms of promotion have been part of the range of patient information, just some of the many tools used to communicate product information.
Clearly, the prescription medications of the 1980s are becoming the OTC medications of the 1990s, and that trend will only intensify. I say that because there are a number of other medications out there that have favorable side-effect profiles and treat common conditions, such as pain, allergy, minor infections, indigestion, hair loss, heartburn and so on.
As I said, the direct-to-consumer promotion for these medications in their prescription forms will and have created a solid base of understanding of them when they reach their OTC forms.
Now, what about information technology? Who in this room can truthfully say that they had heard about the Internet in 1984? But today there are numerous web sites with health-related information, and the profusion of electronic mail allows this information to rapidly move from person to person. Just about anyone can download information about medications, surgical procedures, and even the latest in biomedical research.
In addition, there is the profusion of 800 numbers that pharmaceutical manufacturers use to establish a dialogue with interested and motivated customers. In this sea of information, solid information and credibility stand out, and they are exactly what pharmaceutical companies are obligated to provide.
All this change means that the typical patient in 1995 is much better informed and more motivated to take part in his or her health care. Given that knowledge, let me discuss what has not changed about direct-to-consumer promotion.
The primary constant is the industry's commitment to the most effective and appropriate use of its products. If people are not using our products because they are not aware of them or they are not aware of what they can treat, that is not maximum efficiency. If people are not complying with proper dosage regimens, that also is not maximum efficiency.
To underscore this comment, let me back up to June of 1992 when I had the privilege of addressing a Food and Drug officials workshop in Buffalo, New York--in the middle of the summer, may I say--on the subject of advertising and promotion. I would like to quote from those remarks.
"I can assure you of this: Anyone in the pharmaceutical industry who purposely engages in misleading or deceptive advertising in order to gain some short-term advantage is either greedy or a fool, or both. And that person will eventually be a loser in a highly competitive industry."
I remain committed to that statement, and I remain convinced that direct-to-consumer promotion should be judged on its merits in an appropriate context. And the merits of direct-to-consumer promotion are more compelling today than ever.
Promoting products directly to the consumer results in better educated and informed users of pharmaceutical therapies. This is highly important in today's complicated and rapidly changing health-care systems. Consumers need to know not only about disease states but also about new or alternative treatments and the best ways to use them.
Of course, pharmaceutical companies communicate significant information about dosages, contraindications, drug-drug interaction, and so forth, to physicians and especially pharmacists, and formulary managers now and others through a number of well-established channels. But direct-to-consumer promotion enhances awareness, and it also arms patients with information similar to and consistent with the information given to these other health-care providers. This helps patients better understand efficacy, safety, and compliance issues. As a result, office visits are faster, smoother, and, I believe, more productive. Also, compliance is likely to be better.
Direct-to-consumer promotion also increases office visits. At first glance, that can look like a cost contributor, but in reality, it is a cost reducer. A patient who has an illness or a problem that affects his or her self-esteem needs and deserves treatment if he or she chooses. The longer that patient goes without it, the more expensive the condition is to treat. And if a patient needs pharmaceutical therapy, which is far and away the most cost-effective and human treatment than any other alternative such as surgery, the sooner he or she gets that therapy, the lower the overall cost of treating the condition is going to be. And once patients are in physicians' offices, direct-to-consumer promotion can also heighten awareness of treatments for conditions that physicians might think of as potentially embarrassing, such as impotence, incontinence, or hair loss--yes, self-serving--or they might think of as obvious, such as the need to quit smoking.
Until there were approved products for such conditions, consumers either thought there was nothing they could do, or they spent a lot of money chasing after unproven therapies. Direct-to-consumer promotion has helped consumers know that there are valid treatments out there. These treatments have passed FDA review. They must be prescribed by a doctor, and they must be dispensed by a pharmacist. We hope we can put the word "caring" in front of each one of those.
In no way does direct-to-consumer promotion circumvent the safety aspects of our system. In other cases, patients have tried one form of therapy or another with little or no success. They may think that improved or alternative therapies are not available. Frankly, some people give up hope of ever getting better. And if there is a medication that can help them, they should know about it. Some might say they have a right to know about it.
Awareness on the part of the consumer is obviously what prompts them to engage into the system for help. Awareness is the main reason for our long-standing direct-to-consumer program with Provera for contraception, Rogaine for hair loss, and our new program coming out this week on treatments for impotence.
The DepoProvera program creates awareness of an alternative to birth control pills and barrier methods to contraception. The Rogaine program stresses that there is an alternative to unproven therapies and expensive therapy. We are very proud of our impotence awareness program that informs consumers that treatment options are available and successful for most men. No specific treatment is mentioned; however, there doesn't have to be. People are more comfortable talking about such things than they used to be, but men need all the encouragement they can to discuss problems like impotence with their caregivers, even their caring caregivers.
I would like to conclude by making three points.
First, questions about the extent of FDA jurisdiction are raised by many serious students on the subject under discussion today. I deliberately did not address this question today because the large question of the social value of direct-to-consumer promotion is far more important. But I can say, however, that if we had a choice, we would prefer that the FDA concentrate on the drug and device approval process, which they have been doing an outstanding job in later on, may I say.
Second, direct-to-consumer promotion enhances the roles of health-care professionals in advancing responsible health care. Consistent messages to all providers and patients about innovative therapies is best done by the companies that developed them. Direct-to-consumer promotion enhances information provided by health-care professionals, and this increases rather than circumvents the traditional safeguards in our system.
Lastly, I recognize the need for checks and balances in disseminating patient information. Flagrant abuses are self-evident. Trade associations develop codes of conduct. Competitors are quick to challenge potentially misleading statements. And, of course, the FDA's role in labeling creates another safeguard.
We believe very strongly that a well-informed patient will be a better compliant and motivated patient. This will lead to better outcomes. Direct-to-consumer is one avenue for better information. It may be the beginning of a process, a search for the optimum choice, the best system of care. It should be encouraged.
Thank you very much.

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QUESTIONS FOR THE PANEL
MS. PEDERSEN: Thank you, Mr. Seaver.
Are there questions from the FDA panel for Mr. Perlman, Mr. Seymour, and Mr. Seaver? Dr. Temple?
DR. TEMPLE: Yes, for Mr. Seaver. Just one of your last statements, you pointed out that labeling remains a safeguard. That is only true if in some way promotion is linked to labeling or limited by labeling. If they have nothing to do with one another, which is certainly a proposal that has been thrown out, that won't be true anymore. Do you have a view about that?
MR. SEAVER: I have a slightly different view than what was presented this morning, Dr. Temple. I guess it goes along these lines: We would welcome the input from the FDA experts who have presided over the review and approval of a particular product on what can or cannot be said about that product as expressed in the agreed-upon labeling.
The specter that I feel is held out when advertising goes on about that product is the continued involvement in the approval process of other products from our company as we are going about the marketing of the first product that we just described.
I think we would welcome the creative, yes, and the studied input of all people who have come to become expert on our medication, and it is our responsibility to see that our advertising, direct-to-consumer or any other form of advertising, is in compliance with that labeling, and we would look for a system that would allow for that.
DR. TEMPLE: You were expressing the--well, not to necessarily use the R word, but the retaliation possibility, or at least that people might let that influence their other decisions, that concern.
MR. SEAVER: Yes, I would be remiss if I didn't point out that it doesn't have to be a very active and aggressive and time-consuming activity. It is really a matter of what is in what sequence and what is the review process, going from the top of the pile to the bottom of the pile kind of thing.
With all due respect, I am surprised, frankly, that there aren't more companies. I suspect this is one of the reasons why there aren't more. But I think we'd work through that. I am not going to be specific in any particular case, but the separation of church and state, as has been proposed, I think is a wise movement. And yet you wouldn't want to leave behind the cadre of people who have become expert in a particular area.
DR. TEMPLE: I just want to assert for the record that if any one of us thought that anybody took an action like that--I admit it is hard to know because these things happen sub rosa, I suppose--we would be appalled and would do violence on such a person.
[Laughter.]
MR. SEAVER: That is very reassuring. Thank you.
MR. PERLMAN: May I just say to that, I am sure that is absolutely a correct statement. But the other part of that problem is that there is a need to convince those out there who deal with the FDA. It is not enough that it is simply the truth from your side, because if their behavior is changed by the fact that they believe that, even falsely, there is any of that kind of appearance of impropriety, the damage is done regardless of how honorable the FDA is.
DR. TEMPLE: We understand that. You would be amazed at how little discretion there is to do that under user-fee goals. I mean, putting something on the back burner is highly visible and virtually impossible.
MR. PERLMAN: Well, maybe it is just another lap around the track, or whatever.
DR. TEMPLE: Well, I am not naive. I understand the anxiety. I have been there a long time. I have not seen that sort of behavior. And there is a cultural attitude toward not tolerating it. We think that is violating the law, violating our oaths, and a bunch of other things.
Can I ask one other question? If I understood Mr. Perlman right, the FTC, instead of calling for something that everybody considers horrible like the brief summary, the FTC requires only the amount of information needed to qualify the information that is being transmitted, that is, to some extent what you have to say in addition to your claim depends on the size and scope of the claim. Did I understand that correctly?
MR. PERLMAN: Well, it, of course, depends on the claim. But, you know, of course, that you have to be careful what you say to the FTC because they will come back and ask you for substantiation of that claim. So certainly there is that requirement, if that is the question you are asking. You just can't make a naked claim and not be able to back it up.
DR. TEMPLE: No, I was asking that question to see if I understood it so I could ask my question. My actual question is: Are you suggesting that the current version of the brief summary is somewhat stultifying because it says you have to put the whole nine yards in even if you've hardly said anything at all, and it is more qualification than there was assertion, and it is all kind of unbalanced?
MR. PERLMAN: Yes.
DR. TEMPLE: Another possibility is that how much you had to say could depend on how much you said in the first place. In other words, if you said if you have hypertension, we make an antihypertensive, check us out, we are good, you might not have to balance much because you haven't said very much. You have just asserted your existence. Or if you said there is now a treatment for benign prostatic hypertrophy, you haven't said very much, so there wouldn't be much to qualify. On the other hand, if you engage in an elaborate comparison with someone else's drug for benign prostatic hypertrophy or a hair-loss restorer--well, no danger of that one--or something like that, you might have more to do in providing balance or providing qualification. There might be a graded scale of what had to be summarized, depending on what you said.
MR. PERLMAN: Your question is extensive, but I think the answer is short, and that is, yes, To the second part of it, the amount of the claim almost defines the amount of--or the extent of the claim or the degree of the claim will define the qualifications.
DR. TEMPLE: I am not sure every speaker's words would have implied that. It seems like that is another range of possibilities, that there be a scale of what you had to say depending on what you were saying in the first place.
MR. PERLMAN: I don't mean to suggest there is an A, B, C, D scale or ladders. It is the claim requires substantiation. Obviously, depending on the extent of that claim, more or less or a different type of substantiation is required to back it up. But I am not suggesting that there is some sort of stairway that you take to substantiate a claim.
DR. TEMPLE: No, I didn't mean that, and I am also not talking about the evidence that backs up the claim. We think we have a standard for that, although I see that not everyone agrees with there being any standard. But I was talking about what you actually had to put into the ad; that is, an ad that was fairly terse, just sort of directed you mostly to a physician, mostly, really wouldn't have to provide any balancing information at all because there wouldn't be anything to balance.
MR. PERLMAN: I think that is correct.
DR. TEMPLE: And it wouldn't have to provide the summary because there would be nothing to summarize about.
MR. PERLMAN: I agree with that.
DR. TEMPLE: Whereas, something that was more extensive and told you a lot about the drug might have to say a little more to provide--
MR. PERLMAN: Yes, I agree with that.
MS. PEDERSEN: Dr. Woodcock?
DR. WOODCOCK: I'm not sure I agree with that. I am not sure that--that almost implies that the body of the ad is trying to put something over on you and you have to have a certain amount of other information in it because it is bound to be somewhat misleading.
You know, I am not really sure that is the conception that many of the panelists that have testified here today have about advertising, although that might be somewhat accurate, if you follow me.
I have a question--
DR. TEMPLE: I wasn't assuming that it would all be rebuttal. It would just be that if you told a little more, you would have to provide a little more context. You would have to tell people more about what disease you are talking about or something, just because there would be a little more to explain.
DR. WOODCOCK: Okay. So that is a contextual argument.
DR. TEMPLE: Yes, that's right.
DR. WOODCOCK: I have a question for Mr. Seymour. I share your view. I have been really impressed today by the amount of unsubstantiated but passionately held assertions about either the benefits or the risks of direct-to-consumer advertising. It is really impressive. We have been told that it is either going to really improve the health-care system or it is going to leave a lot of baffled and ill-informed consumers wandering around.
But I don't totally--I like the proposal for a study because I think with some many poles of information, the only conclusions we could truly make may be data-driven conclusions. But what parameters would your study answer? It would mainly involve--some of it could be about the attitudes of consumers toward direct-to-consumer advertising, how they felt about it, which is the examples you cited. There might be some correlations which you describe between degree of exposure to this kind of information and certain behaviors or level of satisfaction.
Is that the kind of information that you are assuming one could gain from such a study?
MR. SEYMOUR: I think most of the interesting part of conducting this would be devising the protocol, because my issue is not your issue and my question is not your question. So I think it would take somewhat less time than the Paris Peace Accords to arrange the table.
But the thought that I am trying to leave here is that we should come together to identify those issues that we feel will move this issue ahead. If we can't agree on the issues, how can we as, you know, cooperative entities really agree on the solutions?
My emphasis, though, we saw some excellent research today, behavioral research about, in particular, the way people perceive, read, digest, are able to understand brief summary information, for example. I would be more concerned or interested in the macro issues that will predict not only if what we are doing now is right but if the policies of the FDA are making it more or less helpful to the consumer.
DR. WOODCOCK: As far as their behaviors or--I mean, we are not going to be able to measure health outcomes in such a study.
MR. SEYMOUR: No, you won't. A lot of that, in my mind--of course, it is just my opinion, and I am telling you my opinion is worth probably what everybody else's opinion is. In my opinion, it would be important to understand if people are taking more responsibility for and more aggressive involvement in their own health care. I think that would be in my mind the best thing that we could discover.
MS. PEDERSEN: Dr. Temple?
DR. TEMPLE: I actually think there isn't complete agreement on what the questions are, and there won't be. There are many people who spoke to such a thing as regulation of promotion here by saying that it really is constitutionally not allowed, and that is really quite independent of whether it is a good thing or a bad thing. It is just an assertion that we just don't have that kind of jurisdiction. So there is a lot of debate about what the questions would be.
But I wanted to pursue Janet's question a little further. There are some kinds of outcomes or surrogates for outcomes that one could actually pursue this way. There is--this is probably more ambitious than what you had in mind. There is an NIH study just finishing up on the effectiveness of active smoking prevention campaigns, and it was done by randomizing cities to either active intervention or no particular intervention. Well, that was a multi-year, probably many millions of dollars study, but there are sorts of things that one could probably think about.
For example, you could see if after a period of heightened awareness attempts more people referred themselves for treatment of high blood pressure or more people that had had a heart attack referred themselves for lowering their cholesterol or things like that. There are some actual sort of outcomes that would not be uninteresting and might help to make the case that at least in some cases there are significant patient benefits.
MR. SEYMOUR: I agree, and I guess an additional point that I want to re-emphasize is that it is not our purpose to delay any further movement on this issue, so we wouldn't suggest an NIH study. But I think there is enough active interest and maybe anxiety in my industry so that people may becoming out of the woodwork to fund this study if we could find the right advisory group to lead it.
MS. PEDERSEN: Ms. Baylor-Henry?
MS. BAYLOR-HENRY: This is for Mr. Seaver. Mr. Seaver, there are those who have argued that the traditional form of direct-to-consumer advertising is somewhat passe, and if your figure of 75 percent of the insured patients will be in some form of managed care, then the question would be: Would it be a better use of resources to concentrate on, say, patient information pieces rather than traditional forms of DTC?
MR. SEAVER: Well, I don't know that there is such a thing as traditional forms of--
MS. BAYLOR-HENRY: Well, traditional in the sense of television advertising.
MR. SEAVER: Television, radio and that sort of thing.
MS. BAYLOR-HENRY: Correct.
MR. SEAVER: Well, the advent of managed care in our system now to me requires another seat at the table, another partner, so to speak, to have that tailored to the interest of managed care. And our premise is based on the motivated patient, and that is going to help the managed-care company do better and do more cost-effective things.
There are certain diseases where more treatment and more costly treatment is cost-effective, and so it doesn't always go in that direction.
I don't see the 75 percent figure as saying that, no, we should no longer be doing this. It is just we need to be doing it in a more targeted fashion, and the technology is there at our side to do that now. With confidentiality parameters built in, we can know among certain plans and certain ZIP codes where the messages can be most creatively and profoundly put out to create the best result, which is better health care in that area for everyone, whether it is hypertension or high cholesterol, the big ones; diabetes is certainly another one.
So a long-winded discussion, but I think it is a partnership with more people at the table, more informed, everybody, including the patient.
MS. PEDERSEN: Ms. Bernstein?
MS. BERNSTEIN: We have heard again over and over how the brief summary isn't brief or a summary. Mr. Seaver, I was wondering if you could comment as a representative here from industry on your views of the brief summary and if you can give us any insight on the rest of the industry's views.
MR. SEAVER: Well, I wouldn't presume to speak for the rest of the industry. I guess my own personal view on it is I don't think it is particularly helpful. It is there because it is required to be there.
When Dr. Temple a minute ago was talking about balancing what you say in the ad with the need for the content and the brief summary, I absolutely loved that. If you are just saying, hey, there is something out there for hair loss, go see your dermatologist, and then you've got to run all the studies that were done since 1810--unfortunately this was a long time coming through the chute--it isn't particularly helpful. And what you are suggesting is it isn't needed.
I would much rather go with something that would be helpful to people, to patients, and I would fall on that side in a minute. And I don't particularly believe that--not because of the fear or the threat or that you can't read the tiny print or all those big words or that kind of thing. I just don't think--it doesn't fit in Time Magazine. You know, what is all this business on this page? Sometimes you come on it--I read magazines from the back so I get to the brief summary first lots of times, and I wonder, well, what is this for? And so I turn it over and I see the color, the smiling face, I say, oh, yes, well, this is what this is for.
I don't care for the brief summary, and I applaud efforts to get better communication. We have an industry of communication experts, people who really know how to communicate. I am not suggesting me as a person or my company as a company. But all the people who coach and help us on this and do the refined research on what are we really saying, what is the customer really hearing, all that kind of thing. That is a very well defined--I am going to even say the science word today. And why we are not utilizing that better in this regard, I don't know. But it is a credit to everybody sitting here to say, hey, we would like to try to do something different.
MS. PEDERSEN: There are no further questions for this panel. Thank you to Mr. Perlman, Mr. Seymour, and Mr. Seaver.
We will now take a 15-minute break. We will reconvene at 3:30.
[Recess.]

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