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Transcript of Direct-to-Consumer Promotion Public Hearing - Panel 1

PANEL 1 PARTICIPANTS

PANEL 1 PROCEEDINGS

DR. PEDERSEN:  So at this point I would like to call the first panel up to the table. That is Andrew Krulwich, Richard Samp, Nancy Buc, and Valerie Robertson. We would start with Mr. Krulwich.
MR. KRULWICH: Thank you, Ms. Pedersen. My name is Andrew Krulwich. I am a member of the law firm of Wiley, Rein and Fielding, and speaking on behalf of the law firm today.
In terms of the disclosures, we represent a variety of pharmaceutical manufacturers, mostly brand name research-based pharmaceutical manufacturers. We have also represented various media interests in connection with advertising and promotional issues as well.
In addition, our presentation today is supported particularly by a research-based brand name manufacturer, and the interest here basically can be summarized in terms of the presentation that we would make today. In summary, our major points are that we--
MS. PEDERSEN: Can I just interrupt for a second?
MR. KRULWICH: Sure.
MS. PEDERSEN: I didn't say--and it sounds like you have finished your disclosure. I am not going to start the timer on anybody until we have finished the required disclosure. So I just wanted to make that clear.
MR. KRULWICH: Fine. Thank you. I appreciate that.
You should know there is a green light here which is telling me to talk, so I will talk.
To summarize, I guess, our presentation and what we would urge on the agency is this: We support and feel that it is important for the agency to have a continued oversight role in direct-to-consumer advertising. The agency has an important role to play in this area. And we do not want to see anything happen that is going to prejudice or hurt the approval process for drugs.
We do suggest, however, that in light of the changes in the health-care system as well as the types of changes we have seen that Bill Schultz referred to in media opportunities, there needs to be more flexibility than the agency has shown in the past towards direct-to-consumer advertising. Once a product is approved, perhaps a different standard for advertising might be applicable rather than the traditional too-well-controlled clinical studies.
Our suggestion is that there needs to be in a sense a change of philosophy. The agency has always looked on direct-to-consumer advertising as something which is probably bad, that consumers are going to be deluged with all sorts of information that they are not going to be able to understand, that more harm than good will come from it.
Our suggestion is that with the changes in the health-care system, there is an important role to be played for an educated consumer to be able to converse with intelligence with the physician, a physician that is no longer in the type of long-standing relationship that he has previously had with the patients, and that direct-to-consumer advertising can provide substantial benefits to quality health care.
In short, if we are talking philosophy--and perhaps as the first speaker it may be appropriate for me to talk a bit more about philosophy--we would urge the agency to rethink its general approach and look on direct-to-consumer advertising as something that it should be supportive of rather than wary of.
With that, let me go to some more specifics. According to a very recent article in the Wall Street Journal, the advertising spending on direct-to-consumer advertising campaigns jumped by nearly 50 percent to $240 million last year. At the same time, it has been over 25 years since FDA promulgated regulations on advertising, and as Bill pointed out, I think it is fair to say that the FDA's regulations at this point are really premised more on the advertising that is going to go to physicians than the advertising that is going to go to consumers.
The print media is no longer the dominant form of communication. There is television, there is 800 numbers, the Internet, the infomercial, computer kiosks in retail stores, and things that we haven't dreamed of yet that are going to come along as ways of distributing both pharmaceuticals and ways of distributing information.
At the same time, we have a radically different health-care market. The doctor-patient relationship has changed dramatically and greatly. Twenty-five years ago, and until very recently, patients had long-standing relationships with their physicians. Physicians knew the patient's history; they knew what the patient had gone through; they knew the medications that had been prescribed over the years. Patients had an understanding with their doctors and could talk very freely with their doctors and knew their doctors over a long period of time.
Today, that isn't the case. Doctors in managed-care organizations often do not know anything coming in about the individual patient except what the chart reveals. They don't have that long-standing history. Without that kind of history, there is a far greater opportunity for miscommunication or lack of communication. And we would submit that direct-to-consumer advertising, if properly done, can provide valuable assistance in providing quality health care in the managed-care environment.
Direct-to-consumer advertisements can encourage patients to ask more questions, more pertinent questions, more directed questions. The advertisements may encourage patients to describe symptoms more accurately and in a more specific manner.
The patient nowadays must be an advocate. We read a lot about patient advocacy. Direct-to-consumer advertising can lead to patients who are more familiar with various therapies, who can be better advocates for their health care in dealing with their managed-care organizations, doctors, hospitals, whatever.
We are in a critical phase now where quality health care is dominated more by generalists than specialists, and the generalists simply cannot know the patients as well as before. We would submit that direct-to-consumer advertising can help here.
In addition, there are some aspects of managed care that may provide some disincentives for the doctors' exploring alternative therapies. Direct-to-consumer advertising, again, provides for a more informed consumer that can ask the right questions, that can probe and explore available therapies that may be very helpful.
We are also in an era of change in that there are heightened expectations for consumers to participate in their own health care. Consumers are much more involved in making decisions about health care, and most of the experts encourage this. The patient is no longer a passive person sitting there and taking whatever the doctor has in terms of advice. The patient's involvement is something that is good both in terms of the quality of health care and the cost of health care.
I think it is fair to say that the agency's approach has always been somewhat disdainful or wary of direct-to-consumer advertising. I think the image is of a consumer who is going to be bombarded by all this information and not know how to deal with it.
Things have changed in that area as well because the consumer is no longer sitting out there alone. There are a plethora of organizations, consumer advocacy groups and help groups, that in a sense winnow out and help provide a distillation of this information. Whether it is Consumers Union, AARP, or groups like that, these are groups that help interpret and can provide information so that the image of the unwary consumer sitting out there and not knowing what the heck is going on and what this information means is really not the case.
I would also point out that outside of the direct-to-consumer area, the FTC has been flexible in the type of approaches that have evolved to give the consumer information in a way that is understandable. New rules on OTC labels seek to give the consumer more information in a readily understandable form. The Nutrition Labeling and Education Act is another example of a greatly simplified, plain-wording type of approach to providing information that, if the research is correct, has been very successful in educating consumers so that they can make appropriate choices.
It seems to us that if these kinds of approaches can work in these areas, the agency ought to consider this type of thing in the prescription drug area as well where you have the intervention of the physician between the consumer and the product. The fact is the consumer cannot go out and buy a product based on an advertisement. The consumer has to go through a doctor. The doctor is there to provide the information, to provide a stop-gap from the concerns that Bill raised in his early remarks about advertising providing misinformation.
Again, we don't and the people we have represented don't for a moment contest that it is important for there to be a balanced approach to advertising. There should be FDA oversight. The question, though, is whether the consumer really needs the information to be given in the form that we talk about now.
If you look at the FDA regulations on, for instance, reminder ads--I don't have the time. I was going to if I had the time to try to read through these. If you read through them and if you are a layman or even a lawyer, it is awfully tough to understand them. I was privileged to be on the panel about a year or so ago in Philadelphia with Ms. Baylor-Henry, and I remember her luncheon speech in which she went through the various requirements of advertising and, if I am correct, ran almost a test for the audience and gave us various examples and asked what we had to do.
Now, I am a lawyer, and there were about three or four lawyers up there with me, and none of us was able to get them all correct.
If you look at--this is the current issue of Newsweek. I am sitting a lot closer than you are, but I have got to tell you I have got to go see my ophthalmologist to try to even see what is in this so-called brief summary. To think that a consumer is really going to read this I think is just a misplaced view. The consumer isn't going to read it.
I am in the sum-up category on my chart here, so I will try to do that and make one or two more points.
The Consumer Product Safety Commission approaches regulations in a less prescriptive way. They have what are called performance standards rather than design standards. The agency sets forth a general idea of what they want and leaves it up to the companies to design products that meet those standards.
We would suggest that the agency here can do the same thing. There is no need for regulations like this in this day and age. This is not 1969. It is not 1979. It is not 1985. It is 1995. The agency can set out standards for advertising that require balance, that require that they not be false and misleading, but permit advertisers to address the changes in media, one set of standards that can fit all media. I don't think there is a need for different regulations for different media. The agency can provide general approaches that would permit advertisers to adapt to the changes in the health-care system to provide the appropriate type of information to managed-care organizations. There is simply no need in this day and age for this type of thing, and despite the fact that it is good for lawyers, probably, there is really no need for this kind of thing as well.
It strikes me that the agency can set out what they want, balanced, not false, misleading advertising, that consumers can then use, can take to their physicians, can engage in a dialogue with their physicians, with their managed-care organizations in a way that is productive for the consumer, that is useful for the physician, that gets the agency out of this micromanagement type of approach that it has found itself in over the last few years, while still providing adequate protection for the consumer.
Thank you.

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MS. PEDERSEN: Thank you, Mr. Krulwich.
We will next hear from Mr. Samp.
MR. SAMP: Good morning. My name is Richard Samp. I am speaking as chief counsel of the Washington Legal Foundation, a public interest law firm located at 2009 Massachusetts Avenue in Washington, D.C. The Washington Legal Foundation devotes a considerable portion of its resources to opposing unwarranted government restrictions on commercial speech and, thus, our interest in the topics being considered in today's hearing.
Let me say at the outset that neither I nor the Washington Legal Foundation has any financial interests in the topics I will address. No one has paid my travel expenses for participation today, and I am unaware of any financial support that the Washington Legal Foundation may have received from those with a financial interest today. I have never even discussed the issue of direct-to-consumer advertising with any employee of a pharmaceutical company, so I am not at all sure what the position of the pharmaceutical industry is regarding the issue.
I am here today because I believe that FDA regulations of direct-to-consumer advertising of prescription drugs are far too restrictive and for no other reason than that.
On July 20, 1995, I filed a citizen petition with FDA on behalf of WLF, calling on FDA to relax regulation of its direct-to-consumer advertising. That citizen petition was one of several filed in recent years with FDA on this topic and apparently contributed to FDA's decision to conduct these hearings.
WLF's position regarding FDA's current regulations are spelled out in some detail in that petition. In my remarks today, I will attempt to briefly summarize that position.
In general, WLF believes that the consuming public is best served by the widest possible dissemination of truthful information about available medical products and services. Moreover, WLF believes the First Amendment severely circumscribes FDA's power to restrict the flow of such information. WLF has proposed several changes in current regulations, most prominently a major overhaul of the brief summary requirement.
My education and experience is as a constitutional lawyer. I have no medical training whatsoever. Accordingly, most of my remarks this morning will focus on legal issues.
Since the mid-1970s, the U.S. Supreme Court has recognized that the First Amendment grants considerable protection to commercial speech; that is, speech such as advertising that proposes a commercial transaction. According to the Court, the First Amendment prohibits the government from regulating commercial speech that is neither false nor related to an unlawful activity unless the government can make three rather substantial showings:
First, the government must show that it has a substantial interest that it seeks to achieve through its regulation;
Second, that the regulation directly advances the asserted interest;
And, third, that the regulation is no more extensive than necessary to serve that interest.
Because it is often very difficult for government regulators to meet all three parts of this test of constitutionality, usually referred to as the Central Hudson test, regulators often attempt to avoid application of the test altogether, and they do so by arguing that the commercial speech at issue is false and that false commercial speech can be banned altogether without regard to the Central Hudson test.
I am here today to tell you that the courts rarely accept that argument unless the speech in question is objectively incorrect. FDA may, for example, prohibit a manufacturer from falsely claiming in its advertisements that its drug has been approved by FDA for treatment of osteoporosis if, in fact, there has been no such approval. But the advertisement may not be termed "false" for First Amendment purposes if the drug has, in fact, received FDA approval, even if the advertisement fails to mention major side effects of the drugs. If FDA wishes to regulate the content of advertisements that are not objectively false, such as by regulating advertisements for fair balance, it must do so within the confines of the Central Hudson test.
As I previously mentioned, the Central Hudson test is not easy to meet. I will assume for the sake of discussion that FDA can meet the first prong of the Central Hudson test, that it can demonstrate a substantial interest in regulating direct-to-consumer advertising for prescription drugs. Presumably, that interest is in preventing the spread of information which, while not false, has the potential for misleading consumers. Even so, current regulations cannot be said to meet either the second prong of the test, the directly advancing the FDA's interest prong, or the third prong, the narrowly tailored prong.
The failure of current regulations to meet the second prong is perhaps best illustrated by the brief summary requirement. FDA purports to justify that requirement as a means of ensuring that consumers are presented with all relevant information about a drug before they approach their physicians and request a prescription for the drug.
The brief summary requirement clearly does not accomplish that purpose. Senior FDA personnel have repeatedly conceded that brief summaries are so lengthy that consumers virtually never read them. Moreover, it would make no difference even if they did read the comments. Commissioner David Kessler has stated that very few consumers can understand them.
I suspect, therefore, that the real reason for attaining the brief summary requirement is to drive up advertising costs and thereby reduce the volume of advertising by making it less cost-effective.
But the First Amendment simply does not tolerate speech restrictions based solely on the disdain for advertising generally, nor do current regulations meet the final prong of the Central Hudson test. They are not narrowly tailored to accomplish FDA's purpose of guarding against potentially misleading advertisements.
FDA could adequately accomplish that purpose if it limited the brief summary to something that really is brief, say no more than 20 words. Indeed, such a requirement would be far more effective in serving FDA's objectives because the likelihood that a consumer will actually read the brief summary increases exponentially as the brief summary becomes shorter.
FDA's fair balance requirement also fails the narrowly tailored test. The principal objection to the fair balance test is that it is so open ended that it allows FDA to object to virtually any ad it does not like. The result is a significant chilling of First Amendment rights as drug manufacturers bend over backwards to produce ads that FDA could not possibly find to lack fair balance. A far more narrowly tailored regulatory scheme would be one in which FDA prohibits a very limited, very clearly defined set of advertising practices deemed wholly inconsistent with the concept of fair balance. Under that scenario, manufacturers would have fair notice of what conduct is prohibited, and the chilling effect on balanced, truthful speech would be minimized.
One other aspect of FDA's regulatory scheme bears being mentioned: FDA's pre-clearance procedures. While manufacturers are not absolutely required to seek pre-clearance, they are under tremendous practical pressures to do so. The pre-clearance procedures are inherently chilling and inconsistent with the First Amendment because they constitute a prior restrain on free speech. The Supreme Court has repeatedly held that "Any system of prior restraints of expression comes to this court bearing a heavy presumption against its constitutional validity" and that the government "carries a heavy burden of showing justification for the imposition of such a restraint." That comes from the Pentagon Papers case.
A system of prior restraint is no less suspect simply because it delays speech rather than attempting to prohibit the speech indefinitely. Indeed, that was precisely the claim rejected by the Supreme Court in the Pentagon Papers case. The Court rejected the Federal Government's argument that it should be permitted to delay publication of the Pentagon Papers until after the papers had undergone a national security review. Thus, similarly, FDA is not in a position to say we are just simply delaying an advertisement until after we have had a chance to review it.
In my remaining time, I want to turn briefly to the practical consequences of the reforms WLF recommends. Critics of direct-to-consumer advertising have argued that it would cause consumers to pressure their doctors into prescribing unneeded medication. There is no evidence to support this allegation. So long as the advertisements are not false or misleading, there is no reason to suspect that many patients will misconstrue the advertisements such that they will make inappropriate medication demands. To the contrary, advertisements might well dispel false notions held by patients that might otherwise cause them to make inappropriate demands.
In any event, the whole point of a system of prescription drugs is to ensure that the final decision regarding the appropriateness of medications remains in the hands of doctors. There is no reason to suspect that they are incapable of fending off inappropriate medication requests from their patients.
We suspect that opponents of direct-to-consumer advertising harbor one other basis for their opposition: a fear that well-informed consumers will make more use of beneficial medications, thereby driving up the costs of health care. We note in response that the First Amendment does not tolerate censorship based on the notion that consumers are better off left in ignorance. Furthermore, there is little evidence to suggest that increased use of drugs where medically indicated will lead to increased health-care costs, particularly if one bears in mind that drugs are among the most cost-effective components of the health-care system.
Lifting restrictions on truthful advertising has worked well in other areas, and there is no reason to think that prescription drug advertising would be an exception. Such advertising can provide, for example, valuable information concerning symptoms which should be checked out with a physician, symptomless conditions for which at-risk groups should be tested, available remedies for previously untreatable conditions, improvements in available medications such as fewer or less serious side effects or more convenient drug dosage regimens, and the availability of possible drug alternatives to surgery.
Experience in markets for other products also suggests that more direct-to-consumer advertising would facilitate competition and encourage consumers to do more price shopping, thus leading to a decrease in the cost of prescription drugs.
In sum, the Washington Legal Foundation supports substantial relaxation in restrictions on prescription drug advertising. At a minimum, FDA ought to reduce the brief summary requirement such that the require summary is truly brief and to eliminate the open-ended fair balance requirement which grants FDA censors the power to ban any ad it does not like.
Thank you very much.

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MS. PEDERSEN: Thank you, Mr. Samp.
Ms. Buc?
MS. BUC : Good morning. My name is Nancy Buc. I am a partner in the law firm of Buc, Levitt and Beardsley, and I am appearing today on behalf of the Wyeth-Ayerst division of the American Home Products Corporation.
In a market economy such as our, information is critical if consumers are to be able to identify and signal to producers their preferences with respect to the kinds of products they want to buy, what prices they are willing to pay, and what combinations of product attributes and prices best suit their needs. If, however, information is either lacking entirely or misleading in some way, then consumers cannot send accurate signals. If they do not know of the existence of a product they would buy, they will buy too little of it. And if they are misled as to a product's attributes, they will buy either too much or too little of it.
Information is also a stimulus to product improvement. When a producer knows that if it improves its product it can tell people about the improvement and expect an increase in sales, it has a powerful incentive to make the improvement. Information also engenders competition, for the more consumers know about their choices and the more they cast their marketplace ballots accordingly, the more vigorous the competitive fray.
But information is not free. Searching it out takes time, effort, and sometimes money. For many decisions, the costs of obtaining and using information are just too great, especially if the product is not very important. For other products, for example, cars, houses, and, increasingly, health-care goods and services, consumers can and do put considerable time, effort, and money into acquiring information that will help them.
What I have said so far applies to information from any source, promotional or non-promotional. Wouldn't it be enough just to encourage patient package inserts, for example, and other so-called non-promotional sources of information about prescription drugs? Definitely not. Advertising is important precisely because it is promotional, precisely because the advertiser spends time and effort and money to identify the people who need and want information, to identify the media which will reach them, identify what they want and need to know, and motivate them to get involved in the process of deciding what to buy.
Advertisers have a special incentive to reduce consumer search costs and thereby increase in the amount of information in the system.
I want to underscore that last point. Advertising is information. Advertising tells people that goods or services are available. A key piece of information that can set in motion a process that allows consumers to match up their needs with available products. Advertising can also provide information about what a product does, how well it does it, what price will be charged for it, and other information that helps a consumer to know whether further inquiry makes sense.
As professor and Nobel Prize-winner George Stigler has written, advertising is an immensely powerful instrument for the elimination of ignorance.
Are prescription drugs different enough from other products that these important insights can or should be ignored? No, they are not. It is true, of course, that with prescription drugs the decision to choose them cannot be exclusively the consumer's. Whether it is the consumer or the prescriber who initiates the idea of the consumer's taking the drug, the prescriber must at the least agree to the decision, or there will be no prescription. But once one recognizes that the consumer does or can or should play a role in the decisionmaking process, then advertising becomes important as a source of information.
Consider just a few of the situations in which the information in advertising can affect the prescription drug decisionmaking process?
A consumer is unaware that hypertension is a silent disease. Upon seeing an advertisement for an antihypertensive, any antihypertensive, he or she begins to consider the issue.
A consumer has stopped taking his antihypertensive drug because it is too expensive. He or she sees an advertisement for an antihypertensive described as being lower-cost and begins to wonder whether there is one he or she can afford.
An advertisement for a treadmill says, Why take expensive drugs which may have side effects when exercise and weight loss are really the first choice? Our treadmill can help you with both of these; talk to your doctor.
A woman who had stopped taking estrogen after her symptoms of menopause eased sees an advertisement about the drug's usefulness in preventing and treating osteoporosis. She takes the issue up with her gynecologist.
A woman learns from an advertisement that oral contraceptives are 99 percent effective when used correctly and are more effective than condoms. She also sees a condom ad pointing out that she can get simultaneous protection from pregnancy and HIV/AIDS from condoms. Her uncertainty about which form of birth control is best for her prompts her to take the issue up with her sexual partner and her gynecologist or nurse practitioner.
A cancer patient who has been dreading chemotherapy and is considering foregoing it learns from an advertisement that new antinausea drugs can help with the problem he is worried about.
This information had not been provided by the HMO physician because the HMO had determined that the cost of these new drugs precluded their addition to the formulary.
A consumer who thought himself well-informed and thought smallpox has been eradicated is amazed to learn from an advertisement that CDC recommends booster shots for tetanus and diphtheria for adults.
A senior citizen is finding it difficult to remove the child-resistant cap from the bottle in which his prescription drug is provided. He and his son see an advertisement announcing that a comparable medicine is now available in a bottle which is both easier to open and still child-resistant.
True, many of the situations in drugs I have mentioned are issues that a physician who is completely up to date, very aware of her or his patients' personal circumstances, and assertive and empathetic in raising such issues with patients would bring up if the patient is in the office. But not every patient comes in regularly, and we must consider not every physician would raise such issues if they did. Empowering the patient as well as the physician with information increases the likelihood that someone--patient, friend or relative of the patient, or physician--will get the dialogue started.
Getting the dialogue started is key to avoiding underuse as well as overuse of prescription drugs, to proper weighing of risk factors, to consumers' understanding why and when and how to take the drugs, to the whole process of intelligent and careful and proper prescribing. The dialogue will be enhanced, moreover, if the consumer as well as the physician is empowered by information to be a responsible and active participant in the decisionmaking process.
Information about drugs can be and is provided by means other than advertising and promotion, but much information in newspaper and magazine articles, for example, is not targeted to the people who are considering or need to consider whether to take a prescription drug and which one to take. Advertising and promotion are targeted, through choice of media and choice of message, and that is why they are so valuable. Also, advertising and promotion for prescription drugs must comply with laws prohibiting deceptive, false, or misleading claims--requirements not applicable to other sources of information.
We must, of course, acknowledge the situation in which the advertised drug is inappropriate, however attractive its price or other attributes may be to the consumer. Then the physician must explain why one drug is less appropriate than another, why taking the more expensive drug is preferable, whatever may be the case. That is the physician's role now. Presumably, he or she is already thinking through every possible option before prescribing a drug. If the physician is not doing that, then the expansion of choices created by the patient's asking questions and making suggestions and getting involved is all to the good.
Even if the physician is mentally checking off a full list of choices, an actively involved patient can still improve the process, not least by communicating directly how he or she weighs the trade-offs that must be made.
Not every patient will want to attend to all this information, of course, and if they do not, that is also their choice. Nor will every physician be comfortable with patients who are such active participants. That is their choice, too. And if patients then go elsewhere, the result will be a better fit between patients and their physicians.
But FDA's regulations for prescription drug labeling and advertising have the effect, if not the intent, of preventing certain kinds of prescription drug advertising and promotional labeling entirely, especially TV and radio. FDA's regulations also make advertising and promotion to consumers more expensive than they should be.
Importantly, FDA's regulations by their insistence on the provision of so much information bury important information under an avalanche of the unimportant.
I, therefore, ask you to rethink the regulatory structure which has created these problems, and in so doing, I would suggest you recognize that the decisionmaking process about prescription drugs is just that--it is a process. And different kinds of information serve different purposes in the process.
All sorts of information can play a part, including advertising and promotion, but not every piece of information has to have the full story. Using that approach would lead to a series of questions about each kind of promotion to consumers and asking what role does it play, who will be using it, for what purpose, what is its relationship to other information in the system, and then how complete does it need to be.
With those kinds of questions in mind, you can look at the existing regulatory structure and consider how it can be taken apart and put back together. I guess this is the Humpty-Dumpty part of the talk. Everyone agrees, I think, that the package insert is the bedrock of the system and does need to be complete. Everyone also agrees, I think, that the full prescribing information satisfies the prescriber's needs for adequate directions for use. It does not follow, however--and the statute does not require--that every piece of labeling, including promotional labeling, carry adequate directions for use.
Knowing that you have that flexibility, then, you can start asking questions about the purpose of adequate directions for use. If it is to make sure that the prescriber knows as much as possible about how to use the drug, then only the prescriber needs all the information. An important first step would be for FDA to make it clear that promotional labeling addressed to consumers need not carry adequate directions for use at all. Perhaps FDA should require or encourage promotional labeling addressed to consumers to tell them how they can obtain the full prescribing information or a consumerized version of it--mail, fax, 800 number, Internet, some way.
In any case, consumers surely do not need the full prescribing information in a situation in which the advertising or the promotion deals with such issues as price, availability, convenience, or other attributes of a drug rather than its intended use, safety, or efficacy.
A similar step, of course, should be taken for advertising. The brief summary now required in advertising is much more than the law requires even for physicians, and as a practical matter, the regulations create a bar to most broadcast advertising of prescription drugs because you can't fit it in a 30-second commercial or even a 60-second commercial. You can imagine hearing it recited in full in a 30-minute infomercial, and you can also imagine being numbed by it.
One way to solve this problem is to consider that consumers need an entirely different version of the brief summary. If the most important thing for consumers to know about side effects and contraindications is the need to consult their health-care provider and discuss the issue, then perhaps the brief summary should say just that. Perhaps a brief summary for consumers should consist of a disclosure that all prescription drugs require a careful weighing of pros and cons in light of the individual's risk factors. Or perhaps there should be disclosure of one or, at most, two key considerations in terms of risk factors like: If you smoke, don't take oral contraceptives. Best bet, quit smoking and then decide.
Another possibility is dispensing with the brief summary and advertisement so long as either a contemporaneous print advertisement contains the necessary information or the full prescribing information or brief summary is made available some other way. Indeed, perhaps the brief summary can be eliminated for any advertisement which explains how to get the package insert or the brief summary.
The reminder advertising and labeling regulations, too, need rethinking in several respects. For one thing, FDA should delete the prohibition against using reminder advertising and labeling for a drug which carries a box warning. A look through the PDR shows that box warnings do not reflect a consistent set of issues nor a consistent degree of risk.
Certainly it is important for FDA to underscore in new policies the permissibility, indeed the desirability, of using reminders for any product, box warning or not, to discuss price, convenience, or any other attribute of the product other than safety, efficacy, or intended use. Information about less frequent dosing, better packaging, or a container that is easier to use, for example, could all be meaningful to certain consumers. And in this regard, it is important not to scorn what may seem like small improvements. Even small improvements can make a difference in a consumer's ability or willingness to take medicine as prescribed. For another, any improvement fosters competition.
If one producer improves its package, another can compete by improving its own package, improving the product safety, or reducing the price. Anything that sets off product improvements or lower price is all to the good.
Finally, there is a great need to change the regulations applicable to prescription drug price advertisements and labeling. Like the reminder regulations, the price regulations are set up as exemptions to the more general regulations, which require either adequate directions for use or a brief summary. But the price regulations allow such exemptions only in the limited circumstance in which the exact price is stated for a specific quantity of drug. A manufacturer will rarely, if ever, be able to use this exemption with respect to the prices charged to consumers. And the regulation does not cover other kinds of price promotion such as coupons or information about percentage reductions. Thus, the price regulations, like the reminder regulations, are too narrowly drawn to allow many kinds of price promotion. The result is less promotion of prescription drug discounts, harming both individual consumers and the competitive process.
In sum, advertising and promotional labeling are important sources of information to consumers who want and need to know as much as possible about the prescription drugs and biologics available to them. Accordingly, FDA should rethink the premises underlying its regulation of direct-to-consumer promotion and then rework the regulations themselves so as to facilitate and encourage direct-to-consumer promotion.
Thank you.

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MS. PEDERSEN: Thank you, Miss Buc.
Dr. Robertson?
DR. ROBERTSON: Good morning. My name is Valerie Robertson, and I am employed by the Drugs Directorate in the Health Protection Branch in Canada, FDA's counterpart. I am the advertising coordinator.
I am very pleased to be here today to share with you the Canadian perspective on direct-to-consumer advertising of prescription drugs. It seems to be a very topical issue because actually I have been invited to speak on the same topic tomorrow in Toronto, so perhaps this is a practice run.
Since the issue of advertising veterinary prescription drugs to the general public is currently under review in Canada, I shall focus on the regulatory approach to the advertising of human prescription drugs.
Like the U.S. legislation, the Food and Drugs Act of Canada is a public protection act, and the limitations and prohibitions imposed are intended to minimize the risks to the general public associated with the use of drug products.
The provisions relating to advertising and promotion of drugs are intended to ensure that the health of Canadians and the benefits of drugs are not compromised by inappropriate or misleading promotional activity.
[Slide.]
This shows the definition of advertising for a drug or advertising under the Food and Drugs Act: "any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic, or device."
The main provisions of the act and regulations relating to drug advertising are shown in the next two slides.
[Slide.]
Section 3 prohibits advertising to the public for a treatment of a Schedule A disease, and Section 9 prohibits misleading advertising.
[Slide.]
C.08 of the regulations prohibits advertising of a new drug before market authorities.
[Slide.]
C.01.044, which we are talking about today, states that promotion of prescription drugs to the general public must be limited to name, price, and quantity only.
In promulgating this regulation, it was considered that the knowledge level of the average consumer is insufficient to allow appropriate interpretation of the limited amount of information about a prescription drug that you can put in an ad. Health professionals, on the other hand, have the background knowledge to evaluate and to set advertising information in its proper context. Through training, they require knowledge of disease, differential diagnosis, the range of appropriate treatment options, et cetera. The average consumer who lacks medical training is, therefore, at a disadvantage in this respect.
There is also a concern that patient demand for medication advertised to the general public would put pressure on physicians and promote unnecessary and perhaps inappropriate prescribing, and thereby expose patients to unnecessary risk. And this would not, obviously, uphold the intent of the legislation.
Other concerns related to direct-to-consumer advertising of prescription drugs have also been expressed. For example, there is the fear that such advertising would drive up health-care costs by increasing the number of medical consultations, and these medical consultations in Canada come from the public purse.
The original intent of allowing advertising to the extent of name, price, and quantity was to allow the posting in pharmacies of the cost of a given quantity of a prescription drug that would in turn allow consumers the opportunity to comparison shop. The results of a Federal Government-sponsored survey conducted with health professionals in 1990 indicated strong support for the current regulatory limitation to the extent of prescription drug advertising to the consumer. More recently, this issue has been reviewed under two separate government initiatives.
Under the first initiative, the food and drug regulations were subjected to a thorough review to publicly justify regulatory programs. Following extensive consultation with numerous stakeholder groups, including the pharmaceutical industry, consumers, and health-care professionals, conclusions and recommendations were published in a report called "The Strategic Direction for Change" in 1993. By this time, a separate initiative to review the Canadian drug approval system and related activities was well underway. The goal of one of the many projects initiated under a Drugs Directorate renewal process was to examine and make recommendations to modify, as appropriate of course, the process for regulating advertising information on drug products. A report was distributed to stakeholders for comment in October 1994.
It is interesting to note that both of these studies led to the conclusion that there should be no change in the status quo regarding direct-to-consumer advertising of prescription drugs for human use. It is also interesting to note that the Canadian approach to direct-to-consumer advertising is consistent with practices in many other countries, for example, the U.K. and Australia. It is also consistent with the 1988 WHO Ethical Criteria for Medicinal Drug Promotion, which states in Section 14 that advertising to the general public should not generally be permitted for prescription drugs.
As mentioned already, the Canadian Food and Drugs Act also prohibits the representation to the general public of any drug as a treatment, prevention, or cure for any of the serious diseases listed on Schedule A to the act, for example, heart disease, kidney disease, cancer, et cetera, et cetera. This, too, is in line with the corresponding legislation in Australia and the U.K. and with Section 14 of the WHO ethical criteria, which states that promotion to the general public should not generally be permitted for a drug for certain serious conditions that can be treated only by qualified health practitioners for which certain countries have established lists.
By the same token, the Canadian Federal Government has no desire to hinder the flow of information to the consumer about prescription drugs, provided it is truthful, well balanced, and presented in an appropriate context, in a way that is likely to be useful to the average consumer. We recognize that consumers are taking a more active role in their own health care and are demanding more information on which to base treatment decisions. However, we have yet to be convinced that advertising is an appropriate way to deliver this information.
The primary purpose of advertising is to sell the product. It is not to educate the consumer, and it is not to provide a range of information to the public on which a treatment decision can be based.
Although advertising does provide information on the particular product being promoted, it rarely provides insight to the condition or symptom to be treated or to other treatment options.
We in the Canadian Federal Government believe that information on prescription drugs can be adequately provided to consumers in a way that is non-promotional and is, therefore, not subject to the regulations pertaining to drug advertising.
In developing such information packages, manufacturers must be mindful of the factors that distinguish non-promotional information from advertising or promotion. The reports stemming from both the regulatory review and the Drugs Director Renewal Project reveal the need for more extensive and comprehensive guidance on the distinction between advertising and non-promotional information. To this end, a policy is currently being developed that will expand upon the basic principle expressed in the current policy on the distinction between advertising and educational activity, that the primary intent of the message must be considered, and if there should be any doubt, then you check the linkages.
The revised policy will give positive and negative guidance in the context of information provided via press releases, CME events, patient support group literature, help-seeking ads, et cetera, et cetera.
We have seem some well-balanced, non-promotional information packages distributed by pharmaceutical manufacturers and by patient support groups under the sponsorship of a pharmaceutical manufacturer that provide non-promotional information on the prevention and diagnosis of a disease and on the range of drug and non-drug treatments available. We have also seen similar information provided in response to calls placed on advertised 1-800 telephone numbers and in sponsored TV documentaries and several other routes. These are just a few which I mention.
I should also point out that in Canada information provided to patients about a drug at the time it is prescribed or dispensed is defined and regulated as labeling and must obviously meet the relevant requirements of the Food and Drugs Act and regulations with respect to its content. Many pharmacies do, in fact, provide information leaflets with a prescription, but this is not mandatory, as it is in the U.K. at least.
In this regard, the recent FDA proposal for a patient education program based on voluntary distribution of information at the time a prescription drug is dispensed has sparked much interest in Canada. In a nutshell, the Canadian approach to direct-to-consumer advertising of prescription drugs for humans is to restrict its content to name, price, and quantity. We are not convinced that advertising is an appropriate way of providing information about prescription drugs since the primary purpose is to encourage the use and sale of a product, not to educate the consumer.
The restriction is believed to contribute to the management of risks associated with the use of drug products, prescription drug products. Although a change in this approach is not being contemplated at this time for human prescription drugs, we are most interested to learn of your experience with this activity in the U.S.A.
Thank you.

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QUESTIONS FOR THE PANEL
MS. PEDERSEN: Thank you very much.
Are there questions from the FDA panel for the members of Panel 1? Dr. Temple?
DR. TEMPLE: This is for Andy Krulwich. You included one statement only briefly that I wanted to pursue, which was that promotion directed at consumers might have a lower standard for the kind of evidence needed to support statements. We are likely to hear in the next couple of days at the next hearing that promotion directed at more sophisticated people like people from HMOs might use a lesser standard. But what you seem to be saying is that promotion to a relatively unsophisticated audience might also do so, and that puzzled me. Can you expand on that?
MR. KRULWICH: Yes. Any advertisement, whether it is to consumers or to professionals, in our view should be balanced and should be truthful and not misleading. The question is whether you need two adequate and well-controlled studies to support that claim or whether some other type of data is appropriate.
Our thought would be that for approval there is no question; you need two adequate, well-controlled studies, you need the appropriate level of data. But for a claim itself, if there is a strong scientific consensus, the kinds of standards that have been used in the NLEA or thought through in the NLEA, and in fact, that the Federal Trade Commission uses in advertising of OTC drugs, are the kinds of things that can at least be considered.
The Federal Trade Commission talks about competent and reliable scientific evidence which basically means strong consensus from experts in the field to support a claim. And we would commend thinking about those types of things as something the agency might do.
I want to be clear. We are not saying that the claim should be unsupported. We are not claiming that it should be not truthful. We are not saying that it should be misleading. But the level of data that is needed to support the claim does not in our view necessarily have to be the same two adequate and well-controlled studies.
DR. TEMPLE: But are you specifically suggesting, though, that promotion directed to consumers should use a lower standard than promotion directed to medically sophisticated people?
MR. KRULWICH: No.
DR. TEMPLE: So you have changed that for all promotion, not just--
MR. KRULWICH: That is right.
MS. PEDERSEN: Mr. Schultz?
MR. SCHULTZ: I have a couple questions. In the early 1980s when there was a lot of activity on this issue, one particular drug company that was very interested in direct advertising of prescription drugs to consumers suggested that it be allowed but that part of the package also be patient package inserts. So that if a company chose to do this kind of advertising, it would also, as part of that, provide patient information, take the responsibility for providing patient information with the drug when the drug was sold, and this was as part of the effort to supply all the information to consumers.
Does anybody on the panel have an opinion about t approach or view of that?
MR. KRULWICH: Well, there is something to be said for that. I guess the real question is whether the patient package insert--or how the patient package insert is going to provide the information.
Our view would be that it should be something that the consumer can understand, that it is in, to use a modern phrase, user-friendly language. Just providing basically the package insert and giving it to the consumer doesn't do it. That's not what we are talking about.
MR. SCHULTZ: I think everybody agrees with that.
MR. KRULWICH: Yes.
MR. SCHULTZ: Ms. Buc?
MS. BUC: A number of drugs already have required patient information. Two of the examples that I used are among them: oral contraceptives and estrogens. But it doesn't seem to me that patient package inserts as such have any particular wonderfulness in deciding what the information should be and who should get it and when; rather, that that is one option among the kinds of things that the agency ought to be thinking about. Where does the information come from? When do they need it?
One thing about patient package inserts, at least as they were thought of in 1980, is that some of the information would have been useful before a decision was made, and some of it was useful after a decision was made. So what I think I am asking you to do is to think through what pieces of information are helpful and necessary beforehand, what pieces of information are more useful or necessary after the fact. Is it different for acute drugs and chronic drugs?
I don't think there should be a Rosetta Stone or a talisman or one thing that everybody decides that must be it. This is a time to open it up and think about what is what and who is who and how to do it.
MS. PEDERSEN: Dr. Woodcock?
DR. WOODCOCK: I have a question for Dr. Robertson. I notice we don't have much representation on any of our panels from the physician community, and I wonder: How did you go about obtaining these opinions that you talked about from the physicians in Canada about direct-to-consumer advertising?
DR. ROBERTSON: Our survey was commissioned, our market research survey was commissioned through a company called Decima who actually were asked to find out a whole bunch of things, and they did it by questionnaire, by interviewing the doctors, not by sending them something and getting a very low percentage of--I don't remember how many interviews were done, but it was tabulated, and there is a report on this.
DR. WOODCOCK: I think it would be useful for us to get that report if we don't already have it.
DR. ROBERTSON: You don't have it?
DR. WOODCOCK: I don't know.
DR. ROBERTSON: You don't. Okay.
MS. PEDERSEN: Dr. Morris?
DR. MORRIS: I had a question for Mr. Samp and for Dr. Robertson. Mr. Samp, you suggested the fair balance requirement is too open-ended and too broad so that FDA can object to any ad, and you suggest as an alternative that FDA describe a limited set of practices which are prohibited.
I wonder if you could describe the kinds of ideas you have for these kinds of practices that we could--
DR. ROBERTSON: You are talking about--
DR. MORRIS: No, I am talking to Mr. Samp.
MR. SAMP: It would seem to me that, first of all, you are never going to get in any ad of any limited length a complete set of information that consumers would ever understand, and I would, therefore, just want to limit the information that you are going to require to the absolute most important piece of information that FDA would insist on. For example, it could have a rule that if there are major side effects that reach a level of danger that--not every side effect needs to be mentioned, but those that might be life-threatening for particular types of consumers would have to get mentioned.
DR. MORRIS: Maybe I was confused. When you talked about brief summary, you said limit that to no more than 20 words. Would this be in addition to or as part of this brief summary?
MR. SAMP: Whatever--I mean, I would assume that you would want a fairly short ad. Whether you have it in one block of the ad or somewhere else, I would say that fair balance ought not to require a lengthy set of information being conveyed in the ad.
DR. MORRIS: My question for Dr. Robertson: You talked about separating advertising versus education, and you said that the primary intent of the message is the way in which--or you are thinking about trying to separate out those two, and I am wondering if you could describe how you might determine intent of message.
DR. ROBERTSON: Well, is the primary intent to advertise for the sale or disposal, or is to provide information?
DR. MORRIS: Would that be determined just by examination of the ad itself?
DR. ROBERTSON: That is right. You would examine it.
DR. MORRIS: Whatever the material is.
DR. ROBERTSON: Review the material like you would. And if it is not clear, we then look at the linkages, you know, who pays, who is sponsoring, and all those sorts of things. You have a list of criteria or factors to be considered that we are developing at the moment.
MS. BAYLOR-HENRY: I also have a question for Dr. Robertson. How are the non-promotional informational pieces that are formulated by pharmaceutical companies disseminated?
DR. ROBERTSON: How are they disseminated? Very often disseminated through cosponsorship with patient support groups. They are also sent to various organizations. They are not obliged to have them pre-cleared by us, but sometimes they send us them just to be sure that they are not advertising. And sometimes they don't, and we hear about them or see them or somebody gives them, thinking that they are advertising them, but they are not. They choose all sorts of ways to distribute them.
MS. BAYLOR-HENRY: Just a follow-up question. So is it conceivable that the pharmaceutical representative could be handing out that piece as long as it is a non-promotional piece?
DR. ROBERTSON: No, I don't think that is really what they are doing, I think because their target audience is mainly consumers.
DR. TEMPLE: This is I guess predominantly for Nancy Buc, but others may want to comment, too.
You detailed a number of very attractive uses and benefits that would come from certain kinds of promotion directly to consumers, and we have internally always thought that there are certain things that consumers don't know about. They don't even know--I mean, if you are a smoker, you may not know that you are sick and that there are prescription drugs that might help you stop; or if you are too fat, you may not know that there are drugs for that. Or you may not know about hepatitis vaccine. There are a lot of things where--or non-sedating antihistamines for that matter.
I realize that you would like to see restrictions on direct-to-consumer advertising diminished generally, but are there some categories that you would define where it is more important than others? Can you imagine a tiered approach where certain kinds of things would be treated more flexibly because it is important that consumers know, whereas others would not? I realize that is not your first preference, but can you imagine it?
MS. BUC: Well, I can imagine it, but that doesn't mean it is a good thing.
DR. TEMPLE: Okay.
[Laughter.]
MS. BUC: It seems to me that different kinds of drugs, different kinds of products, will be advertised or not, depending in part on whether there is anything to say that would be attractive in advertising, whether there is information to be supplied that somebody wants to use, depending on the nature of the drug, simply as a commercial matter. There are some drugs that it is hard to imagine that there would be any commercial interest in advertising them. Anesthetics is the one that usually comes to mind--apart from jokes about the ads putting you to sleep.
But it seems to me that it is important to leave those kinds of issues about what should be advertised and what needs to be said to the decision about whether there is something to be said. Some marketers will choose not to market that way. They will choose to do it some other way.
In classical marketing lore, most people think of coupons, for example, with price reductions as an alternative to advertising. Some will do one. Some will do the other. But I wouldn't put a priori restrictions on the kinds of drugs that can be advertised. The only limitation is one that is already in the statute, is already in the law, and that is that the claims not be false and misleading. But other than that, people, marketers and consumers both, and physicians, everybody in the process, should have an opportunity to think through: What do we want to communicate? Is it worth communicating? Are consumers interested in it? See what happens. If the claims are truthful, if they are not false and misleading, the system will equilibrate with what needs to be said.
MR. SAMP: Briefly, if I could just second that, I think that it is important for this group to know that, yes, there are many uses of advertising, but that ought not to guide the decision. We ought not to be saying, well, certain types of advertising are useful, we will allow them, but other types are not useful. Advertising, if it truthful, is protected by the First Amendment, and we ought not to be sitting here and deciding it is not appropriate to advertise that a particular drug will enhance your life-style because that is not useful information.
MR. KRULWICH: The only thing I would add to that is simply that I think the mind-set is one that you have to rethink a little bit as you are at this point revisiting the whole issue, and not be thinking so much in terms of micromanaging each individual ad or sets of ads or categories of ads. I think you have to think about the approach. What is the approach the agency is going to take towards direct-to-consumer advertising? Is this something that is a good thing, or is it something that we really don't like but we are begrudgingly going to be doing or giving some more permission to?
The latter I think is the wrong approach. There are some real benefits in this day and age to direct-to-consumer ads, and I think that you ought to get out of the micromanaging business.
MS. PEDERSEN: Thank you, Mr. Krulwich. I think Mr. Schultz has what probably needs to be our last question.
MR. SCHULTZ: If the agency is to allow this type of advertising, I think we need to assume that there are going to be instances where companies are going to go over the line, that there will be cases where there will be false and misleading advertising. And my question is: how should the agency deal with that problem?
You know, it can range from pre-review of ads, registering the ads, the various kinds of sanctions we have in the statute, corrective advertising. How do you imagine that the agency will ensure that the advertising isn't false and misleading?
MS. BUC: I think that the answer to that comes from experience not only at FDA but at the Federal Trade Commission and, indeed, among advertisers themselves under the Lanham Act in which competitors can bring cases against their competitors for false and misleading advertising.
The answer is that you have ample enforcement opportunities, and if advertising--pre-clearance is not the right answer. The right answer is to have an enforcement operation which has means of screening the air waves. It won't be difficult. You will have the usual number of competitors turning each other in.
You look at the advertisement. You make some judgments about whether you think it is likely to be false and misleading. If you think it is, you can take any enforcement action that is now open to you. And there is no reason why you can't do it quickly. Other agencies, other entities bring cases quickly if that is what is necessary to do.
I think what you are going to find is that there are--advertisers know how to write advertising that is not false and misleading, and by and large, that is exactly what they do do and exactly what they will do. And if they stray, you bring a case, just like you do now.
MS. PEDERSEN: Thank you, Ms. Buc. Anybody else on the panel want to make a brief comment?
DR. ROBERTSON: Yes, I would like to make a brief comment regarding pre-clearance.
In Canada--I am talking about now about OTC advertising--the broadcast advertising under the Broadcast Act has to be pre-cleared; whereas, print advertising to the consumer about non-prescription drugs is not pre-cleared. And there is a vast difference, and I underline, a vast difference in the level of compliance. Stuff that is pre-cleared, there is very little problem with. The print advertising, there is a big problem with it. So I have a lot to say in support of pre-clearance.
MR. KRULWICH: Let me just add here, I agree with what Nancy has said in terms of to enforce, bring cases. That is what regulatory agencies do. That is what they have always done. That is what the Federal Trade Commission has done for years. And the Lanham Act provides for relief.
In terms of pre-clearance, I do think that over here you run into some serious First Amendment issues, and I also suggest that--I am not sure that you want to set up a big bureaucracy to be pre-clearing ads at this point. I don't know. Maybe in Canada it hasn't been a particular problem. I can see here it becoming such a problem.
MS. BUC: How can it be a problem in Canada if they don't have any ads?
[Laughter.]
DR. ROBERTSON: We have a lot of ads. We absolutely have a lot of ads. And to pre-clear the broadcast ads takes half a PY.
MS. BUC: Well, sure, they say price, quantity, and name.
DR. ROBERTSON: No, no. I am talking about OTC, which has to be pre-cleared.
MS. PEDERSEN: If I may, thank you very much to Panel 1, Mr. Krulwich, Mr. Samp, Ms. Buc, and Dr. Robertson.

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