Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

About FDA

Transcript of Direct-to-Consumer Promotion Public Hearing - Panel 5




[1:20 p.m.]
MS. PEDERSEN: The next panel will be: John Kamp, Thomas Lom, and Dan Jaffe for Panel No. 5, and we will begin with Mr. Kamp.
MR. KAMP: Thank you very much. I am John Kamp. I am senior vice president of the American Association of Advertising Agencies, the national trade association of the advertising business. I will try to speak directly to your disclosures. If I haven't got them all, we will try and make sure.
Over 50 agencies that are members of the 4-As specialize in health-care communication, assisting companies with the complete array of specialized communications in these areas, including medical education, marketing research, public relations, medical journals, and, of course, direct-to-consumer.
I am paid from the dues of these agencies, and my activities here today are on their behalf. I am proud to represent them today. Like all doctors and patients, as well as all drug companies, 4-As agencies do have a direct health interest in DTC advertising and a fundamental financial interest as well.
The FDA enjoys a deserved reputation as one of the premier consumer protection agencies in the world. No one wishes to lose or diminish this unique asset. We share the FDA's desire to constantly improve the quality of health care available to American citizens, and we appreciate the role of the health-care watchdog played by the agency.
We are delighted that the FDA convened these hearings and appreciate the opportunity to make some observations. At the outset, please understand that the 4­As testimony today addresses broader reforms that the association hopes to pursue in the coming months both here and in some cases on Capitol Hill.
We have written Commissioner Kessler and William Schultz asking for an opportunity to address these reforms in their offices, but so far we have received a reply only from Dr. Kessler suggesting that we offer our reform suggestions at this hearing. So we will.
We are very interested in direct-to-consumer advertising of pharmaceuticals. We support the testimony of Tom Lom, the president of the William Douglas McAdams agency, who is speaking also today on our behalf as part of the Coalition for Healthcare Communications.
But DTC advertising is only one part of the drug and device marketing jurisdiction of the FDA that we believe needs some changes. As does the coalition, we believe we begin with a common ground with you at the FDA; that is, all marketing regulations should serve to increase the ability of doctors to treat patients and patients to participate in the health care. And to that extent, and to the extent possible, FDA regulations should enable the broadest possible dissemination of truthful information to doctors and patients.
Unfortunately, some FDA regulations, perhaps including the ones we are talking about most directly today, appear to decrease the availability of state-of-the-art medical information to doctors and patients. The end result, we fear, has been to delay the delivery of some effective and economically efficient health care.
The uniquely powerful authority of the FDA derives from two sources: first, the agency's control over the access to the marketplace through the drug and device approval processes; and, second, the broad authority to regulate communication from the industries. Thus, the 4-As has proposed two sets of recommendations.
I am summarizing my comments, so if you are trying to follow them, I don't think you will be able to. I am sorry. I have a much shorter version than the one before you.
Thus, the 4-As has proposed two sets of recommendations. The first calls for major procedural reform and the second for serious substantive reform; and although some of these would require some changes in the Food, Drug, and Cosmetic Act, most of these could be accomplished here at the FDA. First, allow me talk about the procedural changes.
We think that Congress should separate the product approvals and the marketing regulations. The FDA should create a fire wall between product approvals and all marketing regulations, if possible. There are two compelling reasons for this change. First is the chilling effect of regulation and enforcement on any company that relies on product approvals from the FDA that seriously undermines the integrity, we think, of the rulemaking and enforcement processes at the agencies. Faced with a rule or enforcement action, a company must comply or face serious specter of retaliation from agency personnel.
Now, I am a former rulemaking attorney with ten years' experience at the Federal Communications Commission, and I believe that employee retribution seldom occurs, here or anywhere else in this city or throughout the government. However, fear is rampant. In fact, the first thing I learned when coming to Washington about 15 years ago was that in Washington perception often is reality. Thus, even the unwarranted fear of retaliation can force a company to comply, even when the savvy company personnel know better.
For example, if a company's financial backers or its stockholders even suspect that resistance to other FDA enforcement policy might delay a pending drug approval, it could undermine that company's market value and financial stability in the marketplace. Regulated industries simply cannot take such risks.
Second, we believe that marketing decisions are often driven at the FDA by the dynamics and policy concerns at the agency of the drug approval jurisdiction, more than by the need to foster drug innovation in a clinical setting. As you know, once a drug is approved by the agency for any indication, doctors are free to use it for any therapeutic purpose. Thus, this undoubtedly enables significant health-care advances in this country. That is why the agency operates on that level. And to the point where in many areas, including cancer treatment, for example, state-of-the-art treatment operates well beyond the technical efficacy boundaries set by the FDA.
Thus, there also is a drug marketing leg in the U.S. that can delay good medical practice, we fear. Separating the drug approval process from drug marketing oversight could eliminate much of that leg and significantly advance the delivery of medical care in this country.
One way to accomplish this reform would be by considering marketing regulation in a unit of the FDA that has no authority for communication with FDA divisions that review drug approvals. This new unit could concentrate on maximizing consumer information, stimulating competition, and protecting consumers from fraudulent or dangerous drugs or practices. The FDA's primary mission is to assure safety and efficacy, of course. The new marketing division would focus on other critical issues: more rapid diffusion, more price competition, more vigorous marketplace for both goods and services.
This more appropriate focus would facilitate a vigorous competition in the medical marketplace that would increase knowledge and option choices for both consumers and doctors, and I think ensure much faster diffusion of ideas and products for the cost-effective delivery of health care.
Now just a moment on some substantive reforms. We think that all substantive FDA regulations should be refocused. The regulatory standard for drug and device marketing could be changed to emulate the basic consumer protection principles of Section 5 of the Federal Trade Commission Act, as discussed by others this morning. As interpreted by the FTC, Section 5 generally allows all providers of goods and services freely to market their products, so long as marketing claims are not false, not misleading, and do not otherwise materially misrepresent the product.
This Section 5 standard for marketing practices prevents fraud on consumers and effectively protects both consumers and sellers. The FDA must give greater weight in its regulations to the realities of the economic marketplace and consumer behavior. Vigorous marketing by drug companies has substantial consumer information, price optimization, and diffusion of innovation benefits. Of course, the FDA should not ignore patient and public health risks, but it should consider them in the context of other major public policy goals such as these.
Current Food and Drug Administration restrictions in marketing are often overly complex, expensive, detailed. In effect, the existing rules seem to avoid all risk of misinterpretation at the cost of suppressing and delaying much important communication. I note also that some witnesses this morning indicated that, for example, in the brief summary requirements when they had read them, they had a very great difficulty understanding them in the DTC context. I as a consumer have that same problem.
Because others are going to discuss this DTC in much more detail in some of those questions, I am going to leave aside my DTC part that is in the record, and I will then defer to Tom Lom. My other second reform, though, in this area is that the FDA should always adhere to fundamental due process. It should recommit itself, I think, to both the spirit and the letter of requirements of fundamental due process, Administrative Procedures Act, and the commercial speech test talked about by others today that impose on the government the Supreme Court under the First Amendment.
Currently, the agency often creates new substantive law through so-called voluntary consent decrees that cannot be appealed by other affected parties and by announcing such policy changes at industry meetings. Whenever possible, the agency, I think, should use full notice and comment rulemaking under the APA.
Third, FDA should reform its regulation of direct-to-consumer communications of drugs. As I said before, I am going to defer all of this to Tom Lom's testimony for the Coalition for Healthcare Communications.
The reform suggestions we have offered are intended to enhance the position we know we share with the FDA; that is, that regulations should only be placed on marketing to increase the abilities of doctors to treat patients and patients to make educated health-care decisions. By adopting our recommendations to separate marketing regulation from the review and the approval of drugs, the FDA would develop more expertise in marketing and consumer protection while at the same time fostering innovation.
The AAAA also agrees with the ideas expressed by Tom Lom. We appreciate the opportunity to comment today. We know that the FDA wants to create more effective and efficient systems for advertising regulations, and we look forward to participating with you in those as the rulemakings and other rules come to bear.
Thank you very much.
MS. PEDERSEN: Thank you, Mr. Kamp.


Mr. Lom?
MR. LOM: Thank you. My name is Thomas Lom, and I am president and chief operating officer at William Douglas McAdams, an advertising agency specializing in pharmaceuticals and medical products. I am here this afternoon to present the views of the Coalition for Healthcare Communications on direct-to-consumer advertising of prescription drugs. The coalition represents a broad base of health-care communications and communication organizations representing individuals, public relations firms, continuing medical education providers, advertising agencies, medical journals and textbook publishers, and other companies involved in medical communication. There are nine organizations in the coalition, and their names are listed in the record.
My agency helped pioneer the use of DTC and is currently conducting DTC campaigns for three pharmaceutical companies. Prior to my joining McAdams, I was personally involved in one of the most effective demonstrations of the power of direct communications of drug information to consumers. I was part of the team working with Johnson & Johnson which dealt with both Tylenol tampering crises, a communications success story which benefited the public.
Let me state at the outset that the coalition's goals are your goals. We share with the FDA and all parties in the health-care delivery system a desire to improve the quality of health care in America while at the same time improving the cost-effectiveness of health care in America. Our role in the system is to maximize the power of communications to achieve these goals.
Let me say that I think that during the course of the morning, we tended to focus on a lot of the glass-half-empty part of this debate, and I think what I would like to focus on is the glass-half-full part of the debate. What we have really got is an opportunity to bring 200 million Americans together with roughly 300,000 physicians and bring them together in a way that fosters the goals that I mentioned.
What I would like to do now is cover what we feel the positive value of DTC advertising can be, the regulatory constraints that we feel impede the optimization of DTC, and finally offer an alternative for your consideration in this regard.
Now, it has been well documented that pharmacotherapy is an extremely cost-effective means for improving the health and well-being of the American public. This has never been truer than today as new drugs are being approved by FDA or existing drugs are being improved for expanded indications, in many cases for illnesses never before treatable with medication.
In order for these breakthroughs in drug development to pay maximum dividends for our health-care system, we must accelerate the process of making both physicians and patients aware of this innovation; otherwise, the benefits of new drug therapies are minimized. Patients might miss out on new therapeutic options if they are uninformed, or there could be a lag in the practice of the latest therapy. As a result, untreated or under-treated conditions could progress to more serious and more costly states, for example, hypertension, diabetes, hypercholesterolemia, prostate BPH, and osteoporosis, for which a new drug has just been approved.
Other chronic problems, while not life-threatening, can cause pain and discomfort which unnecessarily affect the quality of life and productivity of millions of Americans, for example, reflux disease, allergic rhinitis, and arthritis. Rapid and clear communication on therapeutic innovation will improve the nation's health and productivity and, as importantly, at a time of concern over costs, save money through the use of more effective treatment modalities.
The use of DTC advertising is an important vehicle for accelerating the spread of knowledge and for heightening the urgency of taking advantage of all of this innovation. So, in a sense, the goal of DTC is to get the patients off the sidelines and into the game and interface with their physician.
I might add, you know, consider how many DTC messages include very prominently the message "Ask your doctor if..."
Now, with regard to DTC regulations, the current system does not seem to advance these goals. Current regulations of DTC advertising of prescription drugs put limitations on the distribution of health-care information to the public, waste advertising funds which could be better spent on further information, and are unduly complicated in their provisions. Without rules designed specifically for consumer media, regulations on advertising to health-care professionals are in place to regulate DTC, and these rules are totally inappropriate to advertising and consumer media.
The sticking point is the requirement that advertisements which mention the product name and disease state for which the drug is used must carry a brief summary. This text is essentially the basic labeling on the product and often requires a full page or more of small type. It is impossible to place this information in a TV or radio advertisement because the cost involved and the impracticality of paragraph after paragraph of verbiage in an ad makes it impractical.
In print media, brief summary has meant that the advertiser has had to purchase additional space to run what is essentially a medical-legal document which is meaningless to the average consumer. Funds which could be better spent on further public awareness and education messages are wasted. The information is inappropriate for consumers who, even if they could understand its content--and we know the vast majority do not--cannot act on it in any event.
To the contrary, it has been shown that consumers are often intimidated or frightened away by this highly technical language and information and choose to remain on the sidelines rather than enter the game and interface with their physician.
To illustrate the problems and inconsistencies with the current system, brief summary need not appear in advertisements in which the product name is shown but the disease is not mentioned. Conversely, if the disease is mentioned, brief summary is not required if no trade name appears. This arrangement has evolved from regulations on medical journal advertising and applying them to DTC in consumer media. The result has been to foreclose TV and radio, two of the nation's most effective mass media in providing information and education to the public, and to limit advertisers to newspapers and magazines where the cost of running extra space for brief summary is less expensive, but still quite burdensome, and with little proven value.
Consumer research has found that the public favors DTC. Physicians, after initial opposition, are increasingly recognizing its public health value. At a time when the public's ability to understand health problems and to act on them can bring down the cost of health care, we need DTC regulations which allow this effective informational technique to become more productive within the health-care delivery system.
Another aspect of FDA regulation of DTC needs comment, and that is the pre-clearance of DTC advertisements. The Kefauver-Harris amendments, the basis for FDA's current policies and operations, did not instruct the agency to review and approve advertising and, in fact, expressly forbids pre-clearance of advertising. Congress provided for promotional oversight, but only after the message had appeared, reflecting a traditional American principle that pre-clearance is censorship. From an informal request for review, we have moved to a de facto pre-clearance of DTC ads. A revision of FDA regulations of DTC advertising must prohibit this practice and comply with Congress' intent.
Let me move now to a proposed alternative suggestion. The coalition suggests that the FDA abandon the brief summary requirement and consider alternatives more suitable for DTC. One such alternative would be that all DTC ads carry the following statement in lieu of brief summary: Prescription drugs can be harmful if not used correctly. All patients are different, and [product name] may not be right for you or your condition. Only a physician can advise you about using [product name]. Never take prescription drugs without instructions from a physician or other appropriate health-care professional.
Such a reminder in all DTC advertising would serve worthwhile public health purposes. It would impress upon the public mind facts currently under-appreciated or unappreciated by many that prescription drugs are potent medicines not to be used casually and that patient and disease variability complicates treatment. It would also emphasize the key role of the prescriber in the use of prescription drugs and, accordingly, reinforce the doctor-patient relationship.
In conclusion, the current FDA regulations impede the potential that DTC represents for improved patient knowledge and action resulting from health-care communications. We should plan today for DTC in the context of an evolving health-care delivery system and increasing longevity of our population.
Thank you very much.
MS. PEDERSEN: Thank you, Mr. Lom.


Mr. Jaffe?
MR. JAFFE : Good afternoon. I am Dan Jaffe, executive vice president of the Association of National Advertisers. I want to strongly commend the FDA for holding these important hearings. They provide a historic opportunity to improve the way advertisers are allowed to provide prescription drug information to consumers.
MS. PEDERSEN: Would you please complete the disclosure statement?
MR. JAFFE: I am about to--or I can do it right now and just say let me tell you a little bit about ANA, which I represent, and that will tell that. I don't want to get ahead of the game, but I represent the Association of National Advertisers. Our 5,300 companies do most of the national advertising in this country, and among our members are many of the major pharmaceutical companies, who obviously have a financial interest in this issue. Though we do not represent any particular product category, we are here to represent the right to truthfully advertise in general. But there clearly is a financial interest of a number of our members.
Now we can go to the time clock.
Gone are the days when consumers were mostly unsophisticated, passive players in the health-care delivery system. Health concerns and the ability to get information about treatment options are among the most important issues facing consumers today. The FDA's current policies for direct-to-consumer advertising were developed over two decades ago to govern print advertising directed to physicians. Given the tremendous changes in the marketplace and society, it is very important for the FDA to adopt policies which are more appropriate to today's environment and which are truly protective of consumers and patients.
We believe that the FDA's current policies are overly restrictive and choke off much valuable information from reaching consumers. We hope that these hearings will result in new policies, policies which will provide more flexibility for drug manufacturers while still protecting the interests of consumers. These two goals are not mutually exclusive; rather, they reinforce each other.
We believe that the FDA's current policies are counterproductive to the needs of consumers and violate First Amendment protections for commercial speech. I think we have to put this whole discussion into a First Amendment context because, clearly, commercial speech has broad protection under the Constitution.
Because of the importance of these issues, we commissioned a detailed analysis by Professor Burt Newborne, a noted First Amendment expert, on the constitutional requirements in the prescription drug advertising and promotion area. I have attached Professor Newborne's paper to our statement, and I would ask that it be included in the official record of this hearing as part of our testimony.
Prescription drugs are subject to massive advertising restrictions that go far beyond those of any other product in our society. After evaluating the FDA's current policies in this area, Professor Newborne concluded that they violate the First Amendment in several respects. He stated, "The current FDA regulatory regime constitutes regulatory overkill, dramatically limiting the amount and quality of information available to consumers."
Professor Newborne described several ways in which the FDA's current policies violate the First Amendment. For example, the policy of urging so-called voluntary--quote, voluntary--pre-clearance of direct-to-consumer promotion functions, in reality has a de facto prior restraint. Given the ongoing regulatory relationship that exists between the FDA and pharmaceutical companies, very few companies can dare ignore the FTC's "request" that all promotions be cleared in advance.
In view of this prior restraint, the pre-clearance requirement is inherently chilling and almost certainly unconstitutional, and we cite cases to point out some of the cases that have dealt with that type of issue.
Second, the policy requiring a brief summary containing a long litany of complex medical information in all product claim advertisements is regulatory overkill. Unfortunately, the brief summary required by the rules is neither brief nor a summary. The length and complexity of many brief summaries makes it virtually impossible to advertise effectively on broadcast media.
Even in print media, the brief summary adds greatly to the cost of each advertisement. The company must print one or two pages of technical information. Also, the information required in the brief summary is far too complex and technical to be useful to the average consumer, which is probably the most important factor, which is that not only do you have to tell too much, but what you tell doesn't help the people who need the help the most.
The brief summary requirement fails to recognize the appropriate role of advertising. Advertising is not intended to be an encyclopedia of all information about a product. Particularly in this setting where a physician must make the ultimate decision to prescribe a product, it makes no sense to saddle all advertisements with a flood of technical information which is of primary use to physicians, not the consumer.
Also, in our view, the current rule that help-seeking materials may not be used, the only available treatment for a condition is the specific prescription drug product is misguided. As stated in the FDA's Federal Register notice, "In such a case, materials focusing on the condition would, by implication, promote the product," as if promoting the product was a clear evil.
Such a policy makes no sense for a consumer with a specific condition who is blocked from receiving truthful, valuable information about a known treatment option. We believe that the FDA's current policies are based on an outdated, paternalistic view of the role of the consumer in health-care delivery, and we are hopeful that these hearings show a sign that those views are now going to be put into the dust bin of history.
While we would agree that in the prescription drug setting doctors know best, consumers must never be left in the dark or overwhelmed by information. Both are of equal danger. As Professor Newborne noted, "Conceptions of the doctor-patient relationship stress the importance of an informed exchange between the doctor and patient, designed to permit the patient to play a role in the selection of treatment. When the FDA overregulates the flow of information to consumers about prescription drugs, it inhibits one of the most effective means of educating patient consumers so that they can play a constructive role in the doctor-patient dialogue."
Now, some have argued that direct-to-consumer prescription drug advertising should be treated as inherently misleading because it contains complex information that must be interpreted by a professional. This notion was explicitly rejected by the Supreme Court in the Bates case. There the State of Arizona sought to ban attorney advertising on the theory that legal representation issues are so complex that any advertisements would be inherently misleading. The Court rejected the argument, ruling that consumers could be trusted to deal with partial information, especially when consultation with a professional is available.
Of course, that is precisely the position of a patient consumer who must discuss information about a prescription drug with a treating physician before he can get a prescription drug.
Others have argued that FDA's restrictions are needed because it is important that consumers get "all necessary information about a drug" and that anything less is inherently misleading. The Supreme Court rejected this theory as well. In the Central Hudson case in 1980, the Court stated, "Even when advertising communicates only an incomplete version of the relevant facts, the First Amendment presumes that some accurate information is better than no information at all." Unfortunately, under the FDA's present rules, the consumer must get either an avalanche of what has been pointed out as marginally useful or useless information, technical information that they can't really absorb, or get no information at all. That is a very bad choice.
We urge the FDA to seek ways to open the channels of communication rather than closing them. Even if the current policies were to survive a constitutional challenge, we believe they nonetheless represent bad public policy. We believe that the FDA can safely adopt--and I emphasize can safely adopt--rules which would be much more First Amendment-friendly.
First, the FDA is a very powerful agency. There is hardly any agency of government that is more powerful and has more tools at its hand to regulate. With broad jurisdiction over every aspect of the pharmaceutical industry, the threat of FDA action is enormous. Therefore a more flexible promotion regulation policy would still have a major adequate deterrent effect on any drug company which considered making a deceptive advertising claim.
Second, since no prescription drug can be purchased without the active cooperation of a physician, the presence of such a reliable gatekeeper makes it unnecessary to have overly restrictive promotion regulations. And if there is some weakness in that area, then the focus should be on strengthening the doctor in his gatekeeper role, not on blocking all information.
Finally, the intensely competitive nature of the pharmaceutical industry assures that advertisements will be closely monitored by competitors. They will alert the FDA, even if the FDA were to miss it, of any area in which their competitors might be falsely or deceptively advertising in some way. So it is very unlikely in this area that somebody is going to be able to slip one by the consumer. These are companies that are going to be in business for a long time. Certainly our members are. Therefore, it is less likely for false or deceptive advertising in this area than others.
In conclusion, let me thank you again for the opportunity to take part in this important hearing. One of the landmark commercial speech cases, the Virginia Pharmacy case in 1976, states best why these issues are so important. In that case, the Supreme Court struck down a Virginia law which banned, interestingly enough, price advertising for prescription drugs. In fact, that is where commercial speech got started, right in the prescription drug area. Justice Blackmun put the issue this way: "As to the particular consumer interest in the free flow of commercial information, that interest may be as keen, if not keener by far, than his interest in the day's most urgent political debate."
For a consumer who faces serious health issues, the ability to obtain useful information about possible drug options is some of the most critical if not the most valuable information he can ever receive. I believe that the witnesses before me have shown that there are more narrowly tailored ways to go at this issue, as the Supreme Court requires. I very much urge you to consider these. If you don't think theirs is the perfect solution, I think we can certainly craft a solution that is far more able to reach consumers effectively than what we have today, which, in fact, cuts off the lines of communication rather than opens those lines of communication.
Thank you very much.


MS. PEDERSEN: Thank you, Mr. Jaffe.
Are there questions from the panel, from the FDA panel? Dr. Morris?
DR. MORRIS: This is to the whole panel, but perhaps more specifically to Mr. Jaffe. There is some testimony regarding prior restraint, and the suggestion is that FDA's request is really interpreted as compelling marketers to submit DTC ads for prior review.
If FDA was to take back that request and a company came to us and said, regardless, we really would like you to look at it, at this promotion we are intending to use, should our policy be to simply say no, that our policy is not to do that? Or should we be more flexible? What would be your suggestion in that regard?
MR. JAFFE: I think that the Federal Trade Commission certainly has been giving advice to companies. I don't see any harm in allowing companies to ask for some sort of advice in regard to particular advertising. But when it moves from that to a request from an agency that has control over the life and death of a company, I think that changes the situation.
DR. MORRIS: How would we know if this person really wants it or feels compelled? Is there something that would permit us to say we really are doing this in a way that is serving your needs? Is there any policy we should follow? Or is it simply enough for us to simply remove that request?
MR. JAFFE: I think if you remove that request and make a clear statement that you don't believe that it is necessary and that all that you are going to require is truthful advertising from drug advertisers, I think that would be certainly enough to have that sort of Damocles, as much as it can ever be removed, taken away. But that if, you know, an advertiser says here's a close question, we'd like to get some input from you, I don't think that would raise the same kind of constitutional issues.
I would be glad to talk to others to get other constitutional scholars' input into this, but that is, at least, my immediate reaction. I will be glad to supply more if you would like.
MR. KAMP: I think you raise a good question, too. I know that companies clearly would like in many instances to make sure that the FDA, you as regulators, see the ads in the same way they do and read them in the same way. And I wouldn't want to say that there should be a system in that you would systematically exclude them. Although I know that the FTC in most cases does that, and in my own experience at the FCC, we refused to see things before.
I think that a way to also sort of solve the specter of voluntary becoming compulsory or appearing compulsory, there is another reason to create this separation, the sort of fire wall separation I was talking about, between the drug approval process and the advertising process. I think the elimination of that sort of specter of their being connected might help in that context also.
MS. PEDERSEN: Thank you. I think Dr. Temple has a question.
DR. TEMPLE: There certainly would be a tremendous--we will get to the separation matter in a second, but assuming the separation isn't entirely plausible or that we still are perceived as one agency, it surely would continue to be very tempting to try to get an assurance that we are not going to object to an ad. That would be a very valuable thing to have. So I guess even if we said, well, you really don't have to, I still wonder whether anybody would believe it wasn't prudent to do it anyway.
Let me just pursue the separation question. Are you saying--you could be saying that you want a different set of people with appropriate clinical advice that they get from people who work for them to carry out essentially the same functions, to make sure it is truthful and to make sure that promotion doesn't go beyond the confines of the package insert. Or you could be saying that advertising shouldn't have to bear any relationship to what is approved or not. And I couldn't tell which you were saying.
One of them really probably--the latter probably requires some revision of the Food, Drug, and Cosmetic Act to suggest that people can promote whatever they want. That is quite a different matter.
MR. KAMP: Yes, and that is why at the onset I said that some of the things can be done here and some of the things can't be done here. I was actually asking for both things. I do think that the substantive law should be changed to use Section V of the FTC Act kind of analysis for advertising that would be separate from the labeling. Just as now the FTC and the FDA look at food labeling and food advertising issues differently because of the different purposes of advertising and labeling.
That is an issue that I do concede, to a certain extent, is beyond the purview of the agency under the scope of the statute as it is now written. But the separation issue even inside the agency is something that I think could be done and would be plausible.
I operated under a similar system at the Federal Communications Commission where the trial staff in many areas did not--the trial staff in specific adjudicatory cases were not allowed to talk to their colleagues about the trial matters that they were in trial, particularly the policy people who were working on similar policies. It worked very well. Inside the agency we were comfortable with it, although it seemed very strange to me at first. Inside the agency people were very comfortable, and outside the agency people were not only comfortable with it, but if they thought that we breached it in any way, they came right in and told us about it.
DR. TEMPLE: And the particular reason for doing that is the intimidating quality of the fact that the same people who approve the drug are giving advice to advertising people on what constitutes a misleading claim.
MR. KAMP: No. It was being done there for a different purpose.
DR. TEMPLE: No. I mean the reason you propose it for us.
MR. KAMP: Yes, to avoid the sort of specter--I mean, we are hearing now more and more about the possibility of retaliation, which I have some doubts about, being in a very similar situation. I think that you and I as attorneys working for the government have too much to do to go out and retaliate against industry. It is just sort of the nature of the job does not lead to retaliation. But the specter and the belief of it out there is clearly rampant in this industry, and I think that the agency has to do something to create a situation where the perception is very different than what we have right now.
MS. PEDERSEN: Dr. Woodcock?
DR. WOODCOCK: It seemed to me when you were discussing this that you really foresaw this separated unit within FDA as really an advertising promotional or improvement unit. Are you conceiving that it would be better for the direct-to-consumer advertising issues of fairness and truthfulness and so on to be adjudicated in the courts?
MR. KAMP: No. No, I mean, I still believe in an FTC kind of situation where truth and falsity and misleading and material omissions and all of that sort of thing can be done inside the agencies. Sometimes they have to go to court. The nature of the Administrative Procedures Act is that aggrieved parties have an opportunity to go to court. But I am not suggesting that all advertising regulation be done in the courts. I don't think that would be a good idea either.
DR. WOODCOCK: Well, I meant between competitors rather than by FDA.
MR. KAMP: That raises a whole other question sort of for a different day. I think that one of the things that could very much advance the ball in most of the arguments between competitors would be the development in this area of a national advertising review board, a self-regulatory system much like we have in the consumer area that is done with the Better Business Bureau. I think that would uncomplicate this area considerably, both for the industry and for the FDA. But that is a whole additional discussion.
MS. PEDERSEN: Ms. Bernstein?
MS. BERNSTEIN: Just following up on this, assuming that we could separate these functions under our statutory program right now--we are a public health agency, and our policies are based on science, and that is pretty much how we run things here at the FDA--how would you propose, if the functions were separated, for the marketing and advertising people to see where things are false or misleading or take some regulatory action if the science is separated from that marketing function?
MR. KAMP: I think the science of the drug approval process is very different from the science of the communication process, and I don't think they have to--they overlap in some cases, but they don't have to or necessarily need to be done in the same unit. I think that is part of the problem of what is going on here. Friday we will be talking about this some more in another context, but the sciences of consumer behavior are very different than the medical sciences in many cases.
MS. PEDERSEN: Dr. Temple?
DR. TEMPLE: That does seem at the heart of it. The job you want to give this new separated unit is maximizing consumer information, stimulating competition, protecting consumers from fraudulent practices, and assuring more rapid diffusion of innovation, more price competition, and more vigorous marketplace. Well, we have essentially no jurisdiction over most of those things, so they would get to sit around a lot because they wouldn't spend time doing what Ilisa wants to talk about, which is seeing whether the contents are accurate and whether they bear some relationship to what has been approved. But as I understand it, you don't want FDA to have any involvement in that if you could manage it.
MR. KAMP: Well, accuracy, truth, and the sort of falsity and misleading, that is all part of what the Federal Trade Commission does every day, for example, in the food area where you have dual jurisdictions. I think that these are manageable. I understand your difficulty, but I do think that these kinds of issues are manageable.
MS. PEDERSEN: Dr. Morris?
DR. MORRIS: I have a question for Mr. Lom, a clarification. You suggested very specific disclosure instead of the brief summary. Would that disclosure apply to both print ads and broadcast ads as well? And how would that work in a broadcast environment, your disclosure?
MR. LOM: What we tried to propose was a suggested alternative that dealt in principle with the kinds of information that we felt should be communicated in the context of brand DTC advertising. So while there is specific language there to help articulate those pieces of content that we feel should be in there, I think we would want to engage in the process of finalizing that specific language. But I think what you can see in there are, you know, various components of what we would view to be fundamental to the inclusion of an appropriate message that any DTC advertisement would carry in order to do things like foster the primacy of the physician and the prescribing process and so on.
DR. MORRIS: So we should interpret this just kind of in principle, not necessary as a specific proposal?
MR. LOM: I think so, yes.
MR. JAFFE: But what he is talking about goes directly to the constitutional requirement that when you regulate advertising you have to have a substantial interest that is directly advanced and narrowly tailored. His proposal would be one way to narrowly tailor the restriction while trying to provide the consumer with adequate information.
Unfortunately, in the past what has been considered to be truthful is that if you don't drop the whole load on the consumer, the consumer is, therefore, deceived; if he doesn't really have basically what the doctor would have, that he is deceived. And we are saying, no, there are ways to narrowly tailor the information and in conjunction with the fact that the consumer will have to go to the doctor who will be--you have in this case not a--we usually make advertising labeling distinctions. But here when you go to the doctor, you have a live person who is a talking label, who can not only provide the information but can assess it. It is a very rare situation where, therefore, we would argue, it would create less need for the whole load, as I have described it.
DR. MORRIS: The brief summary requirement is part of the act, and I am assuming--
MR. JAFFE: As it's defined by regulations.
DR. MORRIS: Right, so we may have--so you are saying we would redefine the brief summary.
MR. JAFFE: And you certainly have that authority under the FDA Act, and the question is doing it in a way that doesn't have a tendency to restrict communication.
MR. KAMP: If I may just for a moment, also this example is one example that FDA, as you may well know, or FTC, as you may well know, might do under it without this kind of a disclosure. There may be a material omission, particularly in an RX drug which does require the learned intermediary. To ignore that whole requirement in an ad might very well be a material omission that would require this kind of disclosure.
MS. PEDERSEN: Ms. Baylor-Henry?
MS. BAYLOR-HENRY: Many managed-care organizations are providing incentives for physicians to spend less time, not more time, with a patient. So in light of that, this learned intermediary's role in providing this additional information may be compromised. Will you comment on that?
MR. LOM: I would be happy to comment on it. I think that in terms of the global objective of trying to provide the highest quality care and making that care as cost-effective as possible, I think that we have seen that pharmacotherapy is a very valuable tool in achieving both of those objectives. And I think that there are a number of health conditions where, if we were to broaden the number of patients who are aware of and ultimately interface with their physician and inquire about the potential use of a prescription drug for a condition, we would be serving the health-care system far better than to have millions of untreated or undertreated patients walking around not interfacing with the health-care professional.
So, on balance, I would suggest that, to the extent that DTC advertising can be a tool to encourage patient-physician interface, irrespective of managed care's particular bias against doing that, I think that we would have an improved global situation as a result. So it is clear that, you know, a lot of managed care is not a big supporter of DTC for the exact reason that you offer, when, in fact, I think viewed globally you could come up with a pretty compelling economic rationale why over the long run they would be far better off to embrace DTC and embrace having people becoming more familiar with pharmacotherapeutic options that could be cost-effective.
MS. BAYLOR-HENRY: But does that argue for more information being included in the direct-to-consumer advertisement since the needed additional information may not be offered by the learned intermediary in the managed-care setting?
MR. LOM: I think that once the patient interfaces with the physician, I would imagine that most, virtually all physicians would behave appropriately in terms of providing the kind of information and counseling that we would expect from the system, whether it is within or without a managed-care setting.
MR. JAFFE: Could I just say one thing to that? Just because you give the patient supposedly more information in an ad doesn't necessarily mean that they are more likely to take in that information. It is not necessarily in this area or any area of advertising more is better. Advertisers, when they really want to get a message across, try to limit the number of messages that you are trying to get to the consumer because they know that they will tune out if it gets to be an overload. And so I think you have got to decide what are the most important messages and see those are there, realizing that there will be more information from the doctor.
Also, managed care, by the way, is somewhat of a backup for doctors. Some people say, oh, well, the doctors will have patients come in and ask for a drug and they will just give it to them. Managed care, I think, is a backup in the other direction to say that there are other checks in the system, not only the doctor but managed care, the pharmacist. There is a multiple checking system here that gives more protection than in virtually any other area of advertising. Obviously the dangers are higher, but the checks are higher also.
MS. PEDERSEN: Dr. Temple, and then Mr. Drezin.
DR. TEMPLE: I thought the last couple of remarks were quite straightforward on this. It isn't so much that in the absence of information in the direct-to-consumer promotion the physician is going to fill in with long lectures on how to use drugs properly. But the physician is the prescriber and, therefore, you can't have responsible prescribing unless the physician does it. The patient alone can't cause that. And, further, you are also arguing, I guess, that nothing much is communicated by the present brief summary anyway, so that you are not losing anything you had.
Of course, that does leave room for trying to make something that is better than that, but that still would be some information as opposed to just a statement that we are not telling you anything, which is what you proposed.
MR. LOM: Well, you may, in fact, be losing something because I think there is certain evidence--it may not be quantitative, but it is at least qualitative--that there are a large number of people who are exposed to the brief summary who end up being intimidated by all of that information and, in fact, rather than take away the positive potential that the message is ultimately designed to communicate, really walk away with the negative impression. Again, my language, they tend to stay on the sidelines instead of get into the game. And I think that our health-care system would prefer to have those people getting into the game.
And, remember, the definition of getting into the game is having a conversation with a physician. It is not going to the drug store and getting the product over the counter and taking it on one's own. So I think that there is some potential downside, and the upside is certainly no greater and is not likely to be as good as what the patient-physician interface would provide in any case.
DR. TEMPLE: I understood that. I thought that was very well expressed. There is still one question, though, that I would like you to address specifically, if you would, which is: Let's say we all agree for the sake of argument that the current brief summary, which is neither brief nor a summary--like the Holy Roman Empire was neither holy nor an empire--isn't very helpful. I think you won't find a great deal of disagreement about that among FDA staff either.
One could still aspire to something that was useful, albeit short--you know, maybe 20 words isn't enough, but 40 or 50 or 60 might be--or one could then go on and say this isn't worth it. It isn't worth trying to summarize all this at all. We will just put a statement that says see your doctor before you take a drug, because it is important and drugs can have risks.
Those are two somewhat different choices.
MR. KAMP: There have been some proposals that I think have considerable merit of doing exactly that, sort of doing it differently in a way that actually provides a lot more information. One of them is the proposal that I heard presented to the FDA a couple of years ago, which would be the development of a series of symbols that would be designed to tell the patients about specific problem areas. In effect, it is sort of picking up on the skull-and-crossbones poison idea and the no-parking sign and developing a bunch of those kinds of symbols. Those kinds of things I think could be done as a substitute or as something that could be done with the brief summary requirement in the statute that might very well enhance communication here.
MS. PEDERSEN: Mr. Drezin?
MR. DREZIN: Bob touched on most of what I wanted to say, but we addressed the brief summary a lot and the proposal for some type of language relating to the harmful effects of prescription drugs. Are you suggesting that that take the place of any balancing information in the ad whatsoever?
MR. LOM: I think what we are proposing is that one alternative is to come up with language that could appear in virtually every DTC ad that provided for appropriate cautionary language that was, in a sense, universal as opposed to having specifically tailored cautionary language for every individual therapeutic category, every individual class of drugs and so forth; and that over time, both in the short run and the long run, you may have more impact, positive impact, with the patient population by having them becoming, if you will, globally conscious in the broadest sense and allowing the interface with the health-care professional be the opportunity for providing the specific cautionary discussion as opposed to having that take place in the context of an ad.
MR. DREZIN: Now, relying on your advertising expertise, we will again be looking at advertisements that are very creative in regard to the benefit information, and then they are going to have a boilerplate-type standard statement, almost a cigarette pack warning, that says, you know, see your doctor, there may be some problems with this product, or however the language comes out. And as advertisers, do you think that is going to be an effective message in regard to, compared to the benefit information that is being promoted?
MR. LOM: I think so. I think that the purpose of DTC is to provide information that can help people get treatment for things that are currently being untreated or undertreated. And I think that we ought to be looking at how to optimize the positive potential to the system of using DTC in the positive sense, and provide appropriate cautions that consumers can deal with and provide a foundation for them to interface with their physician about some of those things.
Again, that gets back to my comment about whether we are looking at this as a glass half-empty or a glass half-full, and I prefer to look at it as half-full. And how do we take advantage of the innovation that is taking place in terms of drug development and the areas that it could be applied to, and getting that innovation diffused as broadly as possible in terms of encouraging people who are appropriate candidates for that therapy to interface with their physician.
MS. PEDERSEN: Thank you. If I might, Mr. Lom, just before we close I wanted to ask this. You mentioned in your statement that consumer research has found that the public favors DTC, and I wondered whether you wanted either to identify some of that research or submit it to the record so we can have the benefit of taking a look at it.
MR. LOM: Yes, I think we could--
MR. KAMP: I think what we are both sort of worried about is that it might be a proprietary study. If it is not, we would be more than happy to submit it for the record. Let us go back and check.
MS. PEDERSEN: To whatever he was referring to there, then. Thank you very much.
MR. KAMP: Thank you very much.
MR. LOM: Thank you.


Page Last Updated: 02/24/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English