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

About FDA

  • Print
  • Share
  • E-mail

Transcript of Direct-to-Consumer Promotion Public Hearing - Panel 7

PANEL 7 PARTICIPANTS

 

 

 

PANEL 7 PROCEEDINGS

MS. PEDERSEN: The next panel on direct-to-consumer advertising this afternoon is comprised of Nancy Sander, Linda Golodner, and Eugene Schonfeld. We will start with Nancy Sander.
MS. SANDER: Thank you for the opportunity to participate in this conversation. My name is Nancy Sander. I am the president and founder of the Allergy and Asthma Network/Mothers of Asthmatics, Inc. We are a non-profit organization helping families overcome asthma and allergies.
Having person experience with asthma in both my family and myself, and also representing roughly 5,000 members and millions of others who receive help through our organization, I want to applaud, first of all, the FDA's efforts to investigate direct-to-consumer promotion of prescription products. From listening to other speakers, it is clear that no one is interested in giving license to purveyors of snake-oil products, to make victims of the sick and the poor. Instead, it appears that the goal is the timely delivery of product information in a format that will educate the public, promote healthy behaviors and present consumers with options to discuss with medical caregivers.
It is only through information that consumers can make informed decision, in asthma in particular. Asthma is a chronic illness where day to day you think about how you are going to breathe, and information helps us lead more normal lives. So the challenge is in protecting the purity of the information that consumers have access to.
Direct-to-consumer advertising can take many forms too numerous to describe today. Therefore, what I am going to do is express some of our concerns and recommendations using asthma medications to illustrate our message.
I am going to start with print media, and because advertising begins with packaging, and packaging comprises print media, I will begin my comments with packaging. I don't know if I could say that again.
Anyway, packaging and inserts we believe need to be more consumer-friendly and yet reflect the weight of the importance of the message. For example, in a metered-dose inhaler package, there needs to be a lot of emphasis on not taking too much of the medication. And so to use terminology such as "Do not use this product unless directed to do so by a physician who has carefully explained the following information" and then outline it that way--I have outlined some of those suggestions in here and will not go through what those suggestions would be, but it is that kind of emphasis that we are looking for in packaging.
It would be wonderful if the FDA could cosponsor with consumer groups such as ours surveys and conduct focus groups to investigate ways to make package inserts more consumer-friendly as part of this program here.
Anyway, print advertising I believe should definitely be encouraged. However, there do need to be some kind of guidelines to ensure standards for product companies and claims, and these should be clear, well stated, and not conflict with product labeling. Artwork, slogans, promotional campaigns, and all related materials should speak only to the product claims approved by the FDA. In this area, what I would recommend at this stage is more or less here is the goal, let's see what we can achieve together.
Manufacturers' claims must be supported by medical documentation, of course, and should not conflict with labeling claims. For example, if a product has not been proven to prevent exercise-induced asthma, it should not use athletes who are using the product in their advertising.
With broadcast media, as with print media, broadcast media should not indirectly or directly offer or imply messages not contained within the product labeling. For example, a current OTC asthma inhaler product in television advertising implies that their product is useful for Olympic athletes with asthma in training and also for nocturnal asthma. And neither exercise nor nocturnal asthma are indicated on the labeling of these OTC bronchodilators. So what we would just encourage is that, you know, someone somewhere needs to pay attention to these kinds of issues, and it should be in whatever guidance is provided by the FDA.
Cost-effectiveness claims, both in print and in broadcast media, should reflect patient use and be supported by verifiable evidence. We have found many, many signs that cost-effectiveness claims are distorted, and we would like to just see that apples are compared with apples.
We do not recommend that pharmaceutical products be sold via home shopping channel methods where more attention is given to the aesthetics of the product than its substance. However, I do look forward to informational programs where a drug's discovery, the development, and ultimate approval lead consumers to a better understanding of illness and how the product fits or does not fit into their health-related needs.
We were also given a whole lot better appreciation for the pharmaceutical industry and the FDA and how you have to work together in order to bring health to America. The evolution of health-care delivery in this country necessitates that consumers become more active in their health care and their medication choices. There is currently more misinformation available to consumers about vitamins, herbal teas, and alternative medicines than access to information about the medications that they need.
Informational advertising and promotion alerts consumers to options that they will recognize as helpful and encourage a dialogue with medical caregivers. This means medical caregivers will need to be more prepared for more questions, and it should also be considered an opportunity to fine-tune the medical needs of inquiring patients.
Life becomes more complicated when we have more choices because we must investigate and weigh the circumstances of our options. However, with input from manufacturers, from families, from medical caregivers and others, guidelines established by the FDA and related government agencies, we believe that direct-to-consumer promotion of prescription products can lead to a healthy America.
That is it.
MS. PEDERSEN: Thank you very much, Ms. Sander.

top


Ms. Golodner?
MS. GOLODNER : Thank you. My name is Linda Golodner. I am president of the National Consumers League. The league was founded in 1899 and represents consumers in the marketplace and workplace. As far as financial disclosure, the National Consumers League has received some funding from a limited amount of companies that do direct-to-consumer promotion. It amounts to 1.7 percent of annual budget.
MS. PEDERSEN: Thank you.
MS. GOLODNER: The National Consumers League welcomes the Food and Drug Administration's current efforts to examine the promotion of prescription drug products directed to consumers through print, broadcast, and other types of media. 1994 saw drug advertising to consumers expand tremendously, to 47 percent from 1993, according to competitive media reporting. We expect that the same increase will be seen in 1995, just looking at the number of ads we see out there.
We believe that this notable shift to empower consumers with information about prescription drugs was brought about by two forces: the general trend of consumers assuming greater responsibility for their health, wanting to know more about drugs that they take and the choices they have; and the shift of consumer health coverage to managed-care systems which often limit the number of medications available to consumers by establishing formularies. I think there is a secondary trend, and that is several switches from prescription to OTC. A lot of drug companies feel it is important to assume their market share when a drug does go over the counter, and you see a tremendous amount of advertising just before it does go OTC, as well as after it goes OTC.
NCL recognizes that advertising and promotional materials play an important role in giving consumers information about goods and services in the marketplace. But there must be a fair balance in what is useful, beneficial information to consumers and disclosure of the risks of drugs to avoid misuse, non-compliance, and adverse effects.
Balancing information provides a framework for consumers to understand and evaluate drug benefit claims, allowing them to form accurate opinions about prescription drugs. False, deceptive, and misleading advertising is detrimental to consumers, and laws prohibiting such activities must be strictly enforced.
The health-care environment and the vehicles through which consumers receive information have changed dramatically in the last few years, and this trend will continue. Today consumers receive a lot of their information on health care over the Internet; they receive it from a variety of ways, from physicians, often through sometimes impersonal clinic, emergency room, or managed-care systems. This does not allow a consumer to have the opportunity to develop a close relationship with a physician or other health professional.
In today's changing health-care environment, good health professional/patient communication about drugs is more important than ever. Physicians or in some instances other health professionals--pharmacists and nurses--prescribe medicine. It is their responsibility to ensure that consumers understand how to safely and effectively use drugs.
Health professionals are the safety net for consumers. It is the health professional who evaluates whether the drug is appropriate for a particular patient or whether there are non-drug or comparable-drug alternatives available. The health professional must discuss the option with the consumer and actively involve the patient in his or her own health decisions. We encourage the strengthening of this relationship with physicians, with pharmacists, and with nurses.
NCL believes that rigorous studies are needed to assess the actual effects of promotional materials and to help guide future FDA policy. We recommend that FDA put out a request for proposal that would assess the effects of direct-to-consumer promotion on public health. FDA should request consumer impact analyses from pharmaceutical companies and other companies that are already conducting direct-to-consumer promotion.
Recognizing the importance of sound studies, NCL does plan to conduct its own research next year on consumer perceptions and the impact on prescription drug promotion. We will share the results of our research with the agency.
We believe and we commend the FDA for its commitment to providing useful patient information to consumers on both prescription and over-the-counter drugs. However, existing FDA regulations on direct-to-consumer promotion of prescription drugs are outmoded. We recommend that FDA develop regulations that pertain specifically to consumer-directed promotional materials. These regulations should include standards for achieving fair balance between the risks and benefits of prescription drugs. The agency should recognize that advertising promotes the sale of a product and, therefore, tends to do a good job of communicating the product's benefits--sometimes, of course, overstating them.
At the same time, however, direct-to-consumer promotion is not very effective at communicating the risks of prescription drugs, such as the side effects and adverse drug reactions. According to research cited by FDA in its MedGuide proposal, the information that actually reaches most patients is focused primarily on how to use the medication, with little precautionary or adverse drug information obtained by most patients.
Unfortunately, some of the information required to accompany promotional materials is often useless. For example, the brief summary is usually in very small type on the page following the main ad and is often in language only a medical professional would understand. NCL believes that if the FDA requires a brief summary, then the information should be presented in a format and language more easily understood by consumers. FDA's efforts to reform the over-the-counter drug labeling could serve as a guide for reforming direct-to-consumer promotion material in a brief summary.
We support a standardized format, information that would be organized with headings and bullets which would break into text, which would be in more manageable chunks that consumers could understand to guide consumers through the information.
In addition, we believe that prescribing information and risk disclosures in broadcast advertisements are generally not effective or informative for consumers. For example, experience with 900-number TV advertisements has shown that consumers do not notice the price per minute and other disclosures in these ads, and we and other consumer groups worked with the Federal Trade Commission to develop new disclosure rules for that industry.
Similarly, other required disclosures on advertisements on TV such as for car leasing and other similar disclosures flashed on the TV screen for a limited amount of time in small type also is useless.
In the case of direct-to-consumer promotion of prescription drugs, inadequate disclosure of prescribing and risk information is a serious concern because consumers base the desire to try a certain drug on a brief image appearing on the screen. Given the short time frame of broadcast advertisements and their emphasis on creating a mental image, it is unlikely that any form of disclosure of prescribing and risk information is adequate to communicate these important usage messages to consumers, especially in 30- and 60-second spots.
With regard to television infomercials which tend to be perhaps 5 minutes or half an hour that promote prescription drugs to consumers, we recommend that a disclosure that the infomercial is an advertisement be printed in large conspicuous letters on the screen at all times.
With computer-based promotional vehicles such as electronic bulletin boards, kiosks in pharmacies, the Internet and other new technologies, we believe that prescription drug promotions should be presented in a standard format so that consumers will recognize the information as advertising. There should be clear disclosure that such computer-based promotional pieces are advertising, not consumer educational materials.
The minimum standards that must be met are scientific accuracy, consistency with the standard format, non-misleading tone and content, specificity, comprehensiveness, understandable language, and legibility.
Any manufacturer-supported direct-to-consumer promotion such as mailings from disease-specific foundations or disease management support services must make full disclosure and adequate disclosure that they are sponsored by a drug manufacturer.
We believe that FDA must be more assertive in conducting its review of direct-to-consumer promotion of prescription drugs to ensure that promotional materials comply with FDA standards. FDA should be provided with adequate resources to conduct such reviews.
Health-care professionals, public-health organizations, and consumer groups should help the FDA by informing the agency of any potentially misleading direct-to-consumer promotion so that FDA can make appropriate enforcement actions.
In order to address some of the controversy surrounding direct-to-consumer promotion, the National Consumers League is inaugurating a project that will build on and complement FDA's work in this hearing by expanding the debate on direct-to-consumer promotion and establishing reliable national data on the impact of promotional material to consumers. In the first year of our project, the National Consumers League will first convene a roundtable of stakeholders on January 17th and 18th in 1996 to discuss direct-to-consumer promotion of prescription drugs with a goal of reaching some consensus on some aspects of this issue among the stakeholders. We will then distribute nationally a report on these roundtable discussions and recommendations and will also do research on consumer perception and the impact of prescription drug promotion. We will also do focus groups as well as a national survey.
We look forward to working with you on this project, and we look forward to seeing something very positive coming out of these hearings.
Thank you very much.
MS. PEDERSEN: Thank you, Ms. Golodner.

top


Our next speaker will be Eugene Schonfeld.
DR. SCHONFELD : Thank you for the opportunity to speak with you today. I am the President of the National Kidney Cancer Association which is an organization made up of patients and doctors involved in kidney cancer. I myself am a kidney cancer patient. I have advanced metastatic disease in both my lungs and in my left adrenal gland.
My comments today are not so much about cancer per se, though, but I am here perhaps drawing on some other expertise--
MS. PEDERSEN: I'm sorry. Could I just interrupt for a moment and ask you to complete the rest of the disclosure statement?
DR. SCHONFELD: Yes, sure.
MS. PEDERSEN: Thank you very much.
DR. SCHONFELD: My views here today are those of the National Kidney Cancer Association. The National Kidney Cancer Association is paying my expenses here today. I own no drug company stocks or any health-care stocks whatsoever. I have no financial interest in any drug company.
MS. PEDERSEN: Thank you very much.
DR. SCHONFELD: In my youth, I used to be an advertising agency executive. I was a copywriter. I worked in the advanced methods group at N.W. Ayer, a large advertising agency. I was also a professor of advertising at Northwestern. I did my Ph.D. dissertation on print advertising, and I have a doctorate in marketing and finance from Northwestern. One of the companies I founded provides statistical reference works to the advertising industry. So I know a fair amount about it.
Let me just make a couple of general comments that perhaps everybody should consider. Advertising is one of those things about which everybody has an opinion. The stock market is the other, by the way. Unfortunately, few participants in this debate are really marketing and advertising scholars. And so one of the dangers here in this discussion is that the FDA will be misled by well-intentioned but uninformed people.
Perhaps I can shed a little light on some of the roles of advertising in this particular context. The mass marketing of prescription drugs is a form of competition which drives down the costs of drugs. When developing mass markets, companies spread the fixed costs of product development over a larger base of consumers. Economies of scale in manufacturing can result and prices can be lower than they might otherwise be. These are generally accepted economic principles which have been demonstrated over time in many, many markets.
What is important about this is the development of mass markets makes it financially feasible to develop many new products. Without mass markets, we may not have new products for certain conditions. In fact, this has long been recognized by the Federal Government when it created the Orphan Drug Act that some small markets actually need additional economic incentives for patients in these markets to get effective drugs. So the development of mass markets is very important, and obviously advertising has a role to play in that.
However, there are many other economic effects which you may not realize of direct-to-consumer promotion and the development of mass markets. One is mass marketing reduces the financial risk of developing new drugs and bringing them to patients. By mass marketing, it is possible to hedge against the loss of R&D investment.
If a manufacturer must commit large amounts of capital to drug development and build expensive manufacturing facilities, one way he can hedge the risk of financial loss is by mass marketing, to make sure that the demand exists for his new product when it is eventually approved by the FDA. If regulatory authorities remove companies' ability to hedge financial risk in new product development, we will get fewer new drugs, including life-saving drugs.
Another aspect of this is that most major drug companies make products which are suitable for mass marketing and some which are not suitable for mass marketing. For the most part, companies know which products are which and set their marketing strategies for different products accordingly.
What is often not recognized is that companies use the cash flow from one product line to finance the development of other product lines. Thus, a mass market prescription drug which generates substantial cash flow can finance the development of new drugs for small specialized markets, such as drugs to treat orphan diseases such as kidney cancer.
To illustrate the point, consider the fact that Bristol-Myers Squibb has spent close to $500 million on AIDS drug development. The cash used to support this development did not come from the sale of AIDS drugs. It came from a whole host of other product lines, including cancer drugs, OTC drugs, cosmetics, and household products. If regulatory authorities restrict the ability of companies to mass market certain product lines, cash flows will be reduced. There will be less cash available to support development of new life-saving drugs.
All products are financially linked through a company's income statement and balance sheet. All products are interdependent. Advertising and marketing can directly reduce the cost of financing new product development by reducing the cost of capital to drug companies.
When a company uses direct-to-consumer promotions, it reaches many people who are not prospects for the product. One such group of people are investors. During the 1970s, I published five papers on the effects of advertising on stock prices. Included in this research was every major drug company. I have attached one of these papers to my testimony.
The details of my research are beyond the scope of this hearing, but I can tell you that one of the most powerful messages in terms of increasing a company's stock price is a new product with real consumer benefits. There is sufficient evidence to suggest that mass marketing benefits consumers through many economic pathways. Regulation based on a limited understanding of advertising may reduce the benefits which consumers receive. As consumers, we should all applaud the effective use of mass marketing.
Much of what the FDA does is micromanage the marketing communications process, particularly the content of marketing messages and the advertising execution tactics used to communicate messages. In this regard, the intent of the FDA is good, but in practice, the results of the regulatory activities are poor. I think this problem exists because the FDA does really not understand the information needs of consumers.
Let me cite a few examples. First, it should be understood that about half of all prescription drugs are bought by older people. This fact means that many drug consumers wear glasses and have trouble reading fine print. This is common sense. Yet if you look at a package insert--and, by the way, I actually brought a drug that I am taking here. It is called alpha-interferon. I have got to show you this. This is going to amaze you.
It comes with two package inserts, by the way, none of which is terribly legible. This is the size of the vial.  There is a label on here. I defy any of you to read it. It is an enormous problem.
The package inserts are basically unreadable, too. Now, this product is made by Schering-Plough, and it is a pretty good product. In fact, the interesting thing, when you actually get this product or the doctor prescribes it, the doctor has to give you a whole bunch of consumer literature developed by Schering-Plough which is readable, because this is not readable.
Now, fortunately, the other material you get is pretty good stuff. It explains to you how to use the drug and all the rest. Why isn't this more useful and consumer-friendly? Where did it go wrong? This went through the FDA. This was regulated.
We paid for that regulation, by the way, as taxpayers.
One of the first things is we really have to ask some basic questions here about some of this stuff. Print ads are just as bad. There is actually a print ad attached to my testimony. It has a complete package insert, I believe, as part of the ad in mouse type, which is unreadable. And all we are doing is wasting a lot of marketing dollars that actually could be spent on informing the public in a useful way.
The next thing, the FDA has a new proposal to have pharmacists give everybody a pamphlet when they get a prescription drug. Well, that is kind of interesting. So what we are going to do is double the inventory of every pharmacy in America. Not only must they stock the drug, but now they have to stock the pamphlets. And just as the drugs have a limited shelf life, I am sure all that printed material will have a limited shelf life.
The fact that the FDA would propose such a thing is of concern to me. It suggests a lack of common sense, particularly in an era of computerization where many drug stores already print computerized information sheets for patients when you get a prescription drug. And there is one of those attached to my testimony, and if anybody cares to read one, this is what Walgreen's issues. This is another prescription drug that I have.
This particular one is completely useless, by the way, in one respect: The medication I am taking for my cancer is called Accutane. It is 13-cis retinoic acid. And it starts out, "This medication is used to treat severe acne." Yet it is part of my cancer therapy.
Why is that? That is because drug companies are prohibited from providing any information on off-label use. And guess what? The information sheet from the pharmacist has no information about the use of that drug in cancer therapy.
We have got a very interesting situation. Let me give you a much more critical view of that.
FDA marketing regulations reduces the flow of prescription drug information to consumers, even when they seek it out. In March of this year, I was diagnosed with a recurrence of my kidney cancer. Since I am president of the National Kidney Cancer Association, I know a lot about my disease. But I wanted to collect some additional information so I could make an informed decision about my treatment options.
One drug that I wanted to know about was gamma interferon which has been in Phase III clinical trials in renal-cell carcinoma, my kind of cancer. Gamma interferon is made by Genentech, but renal-cell carcinoma is not the labeled indication. I started my information gathering with a computerized search of the medical literature on gamma interferon. However, I still had some questions, so I called Dr. Virginia Eaton, an oncologist at Genentech, who was the clinical research director on the product. She refused to tell me anything because to do so would violate off-label marketing regulations of the FDA.
Instead, she referred me to a doctor at M.D. Anderson Cancer Center who had been involved in clinical trials of the product. Unfortunately, the doctor at M.D. Anderson refused to talk to me unless I personally flew down to Houston, Texas, and submitted to a medical evaluation of my case and was willing to be treated by M.D. Anderson.
In short, FDA regulations block the flow of potentially life-saving information to me as a consumer, even when I was smart enough to know who had the information and motivated enough to seek it out.
FDA regulation also increased my information acquisition costs. Any economist will tell you that information search costs determine demand and usage of information. If information is costly in terms of money and/or personal time, consumers will consume less of it and will be less informed. Many FDA regulations raise the cost of information for consumers, particularly restrictions on direct-to-consumer communication. Thus, FDA regulation defeats the very goal which the FDA seeks to further: having a well-informed public making good medical decisions.
Direct communication between producers and consumers is often the lowest-cost way to transfer useful information to people who need it. Moreover, direct-to-consumer information is often more accurate than information filtered through doctors, nurses, pharmacists, and others who may forget important details or emphasize the wrong things or convey erroneous information. Yet current FDA regulation impedes the flow of information between producers and consumers.
I might add in managed care, where doctors have a financial stake in the prescription budgets of the managed-care organization--that is, they get paid bonuses at the end of the year if there is money left over in the prescription drug fund--has an enormous influence on the flow of information through physicians today.
I have seen some cases where patients have actually called me and my only conclusion is that the doctor, the oncologist who is advising them specifically tried to scare them to death with the side effects of cancer drugs to make sure that the patient wouldn't want to be treated.
I have suggested to such patients that they go outside the HMO and get a second opinion, even if they have to use their own money to do it. But we have seen such things happen. At least at this point in time it is not a huge problem, but direct-to-consumer marketing communications is a very important safeguard in the managed-care world, in my opinion, and we need to really think about that a lot more.
The National Kidney Cancer Association has been deeply involved in the whole debate over FDA reform. One of the key elements of our FDA reform proposal is making the FDA a provider of information like the SEC. The regulatory philosophy of the SEC is to increase information disclosure by companies so investors are fully informed when they buy and sell securities. The regulatory philosophy of the FDA is to decrease the flow of information from companies to consumers, preventing patients and physicians from being fully informed when they purchase drugs.
Both regulatory agencies are supported by the same taxpayers and are supposed to serve the same public. Both agencies protect the public by reducing risks--in one case financial risk, in the other case medical risk. Yet the SEC and the FDA approach risk reduction in diametrically opposite ways.
MS. PEDERSEN: Dr. Schonfeld, could you wrap it up in about a minute, please?
DR. SCHONFELD: Yes.
MS. PEDERSEN: Thank you.
DR. SCHONFELD: There has been much discussion about harmonizing FDA regulations with those in other countries. I recommend that we harmonize the FDA with the SEC and get the FDA to protect us by becoming the authoritative source for accurate information about the clinical use of prescription drugs.
Next week I am giving a talk at a conference on Internet medicine. One of the very interesting things that is going on is we have a whole growth of what I would call unregulated drug information going on. That is the Internet computer bulletin boards and so on.
The danger for the FDA if it does not really get into the information disclosure business like the SEC is it is going to be irrelevant. All of these hearings are irrelevant because most of the information available to consumers will not come from drug companies or the FDA. It will come from third parties entirely--doctors, other patients. And so I think the most fundamental issue is what is really going to be the role of the FDA in the future of drug communication in this country.
MS. PEDERSEN: Thank you, Dr. Schonfeld.

top

QUESTIONS FOR THE PANEL
Are there questions from the panel? Ms. Baylor-Henry?
MS. BAYLOR-HENRY: First of all, I would like to just begin with a statement for Dr. Schonfeld. We recognize the difficulty that you faced in trying to obtain information from a pharmaceutical company. But to the extent that the company did not give you information based on what they misstated as an FDA violation, that would not be correct. Companies can give information to unsolicited requests based on FDA's current position on these issues. So I just wanted to set the record straight on that.
DR. SCHONFELD: It seems to me, then, you've got a job to do in terms of educating companies as to what they can and can't do.
MS. BAYLOR-HENRY: I absolutely agree, and we intend to do that. Thank you very much for bringing that to our attention.
I also, if I may, have a question for Linda Golodner. You stated that on the Internet you believe that drug advertisements should be presented in a standard format that makes it easily recognized as an advertisement. Have I misstated what you--okay. There seems to be varying schools of thought as to what would be easily recognized as an advertisement. Would you then recommend that there be the bold word "advertisement" on a company's home page?
MS. GOLODNER: I should think there would be some sort of disclosure that would say "paid advertisement" so that consumers would understand where the information is coming from and use that in evaluating whether or not they want to take everything that they read on the Internet or they see as--so that they can weigh the information.
We feel that this is true with a lot of the other promotional material that is distributed that may be paid for by a company and not mention some of the risks that may be--risks of the drugs.
MS. PEDERSEN: Dr. Temple?
DR. TEMPLE: This is for Ms. Golodner. Many people who have spoken today thought that it wasn't particularly necessary that direct-to-consumer promotion emphasize or discuss at any length risks because they basically felt that that is the job of the physician to provide a balanced view about whether the drug should be prescribed.
You expressed a contrary view. Would you care to elaborate on it and say why you don't agree that the learned intermediary is sufficient protection?
MS. GOLODNER: If a pharmaceutical manufacturer believes that the promotional material is, in fact, patient information, which I think that is the message that they are trying to give, I think it should be treated as other patient information. And I was trying to relay it to some of the MedGuide proposals that there be information that is both the benefit and the risk of the drug presented.
You might want to look at what the NLEA requirements are for some food products, that there be, for instance, maybe some model messages for certain drug categories and model claims that would be required for some advertisements. But I think you have got to have the adverse drug reaction and the risks included because, according to your own research, these are the messages not being given by the physician, not being given by the pharmacist, and consumers have to get it some way.
DR. TEMPLE: Let me just press that a little. It is an important point, and I am certainly not expressing disagreement or agreement. I just want to give you an opportunity to explain it.
The other examples you cite are somewhat different. The MedGuide is something you get when it has been prescribed for you, and it mostly is devoted to telling you how to use it, not to help you to decide whether to use it. There are some exceptions to that, but mostly that is not what they are for. And, of course, under NLEA, foods, there the patient or the consumer is making the whole decision, so there is a better case for saying you need to give the pros and cons.
Here, though, the contention, at least, is: What are you worried about? The physician is going to take care of all this in the form of a decision whether to prescribe it or not.
MS. GOLODNER: You know, it is interesting the way that people get medical information. When I say MedGuide, I can't think that that is the only way someone is going to get information. They are going to get it from a news article. They are going to get it from printed information. They are going to get it from friends. And MedGuide is going to be a part of that information that consumers receive about their drugs that they are taking.
So I consider this all wrapped up into patient information as a macro that consumers receive this information in a lot of different ways. And I think that we have got to emphasize that there has to be a message about risks that are given as well as the benefits of the drug.
MS. SANDER: May I comment? This is really a very practical matter. You don't always have in every piece of advertising or advertising opportunity the time, if you have got a 5-second spot versus a 15-second spot versus a 30-second spot. It depends on how infomercial it is versus, you know, are you trying to sell a concept--you know, "Asthma can be controlled. Ask your doctor about" whatever inhaler versus, you know, "This inhaler is great. It cures asthma." You know, then starting making claims like that, then, yes, I think that you do need to--there is a context as to the positioning of information. You don't always have time to present risks as risks. But you can present risks, for example, when you are talking about--if it is an infomercial-type, and I am going to use asthma again. You know, making sure that you do not use this medication more than X number of times a day or it could be a sign your asthma is worsening, talk to your physician. That is a way to present a risk without it being risks of using this drug too many times could kill you.
But I think that it is just a balance of presenting information.
DR. SCHONFELD: I would like to make a comment, too. You know, we have this idea that we should spell out in detail how the ad should be written, how many words should be in the headline. We have to have this section of the ad and that section. That is a very mechanistic view of the communication process. And I am not so sure that necessarily produces in the end better communications.
Yes, we have the words there and the lawyers told us that we used the right words and all of that. But I don't know that it necessarily leads to better communication. It is like a great novel. You know, an ad is like a great novel. It communicates. It just doesn't have words on a page. And having been a copywriter and sat down at my desk and put a blank sheet of paper in a typewriter, that is where the rubber meets the road, for those of you that wonder about advertising.
I think it is like pornography. I know good communication when I see it. And I think rather than try to write prescriptions about how ads should be written, I think the FDA needs to perhaps learn a little bit more about how advertising really works and what doesn't work. And perhaps there needs to be some research methods developed to tell you when an ad communicates and when it doesn't.
Also, we have heard before more information is not necessarily better communication. It is simply more information. So I think some of the proposals that we have seen today here that would spell out all the details, forget it. That is not the real world. Don't even try to open up that can of worms. Concentrate on whether the communication process is facilitated or not.
MS. PEDERSEN: Thank you. I think Dr. Woodcock has a question.
DR. WOODCOCK: This is to all the panelists. I think this panel and the discussion you are having really illustrates the tension that we have here. Everyone desires better communication with consumers. The FDA does, consumers do, the manufacturers do. But there is a tension between the desire for full communication and the other desire I have heard expressed on this panel, which is that somehow that there be some standards that the communication, even if it is effective, be somewhat accurate or truthful. And I think where we really get stuck is in the methodology of ensuring that.
DR. SCHONFELD: I think good guidelines, frankly, would go a long way to doing that. But we don't have to, you know, go into nauseating detail over how big the type is.
MS. SANDER: Is it possible to open opportunity for advertising--this is probably a very naive question, but having certain areas that cannot be violated, but then, you know, open it up and see what happens?
[Laughter.]
MS. GOLODNER: I go back to my suggestion that you look at some model claims or model messages that would be necessary in ads for particular drug categories. Not constraining the whole ad, not writing the ad, but making sure that there is truthful, non-misleading information for consumers in that ad.
MS. PEDERSEN: Dr. Morris?
DR. MORRIS: Just in the sense of setting the record straight, I wanted to comment on Dr. Schonfeld's experience with getting information and your comments about information at the pharmacy. The FDA's rule or proposed rule regarding MedGuides would not require an additional storage of information. It would permit pharmacists to distribute computer information. It wouldn't require double counting or double storage.
But further on that point, you are certainly one of the few consumers that is so information hungry and seeking information very actively, and yet you responded very negatively to the inclusion of the physician insert. Was that inclusion simply because you couldn't read it, or if it was in a better format, or is it totally unnecessary for you?
DR. SCHONFELD: No, it's fine, except that the mouse type is a little hard to read. No one has looked at, frankly, the package insert or what is on this little tiny label and asked themselves, Can anybody read this? It is basic common sense.
MS. PEDERSEN: Dr. Temple?
DR. TEMPLE: It actually turns out that you would like us to get into certain nitty-gritty details like type size, not stay--
DR. SCHONFELD: Well, you have. That is my problem.
DR. TEMPLE: No, but we--
DR. SCHONFELD: I assume the size of the type is because of the regulations you have.
DR. TEMPLE: Not exactly. We specify a minimum type size, and what you saw is the use of the minimum, probably. We know you can't read them either without doing something with your glasses.
Let me ask one other thing about the mass marketing part of your talk. I want to be sure I understand the implications. I think we understand that companies produce drugs that are not necessarily millennial in the hope that they will get a share of a large market, and they need to be able to compete for that piece of the market. And companies are worried, I understand--and I am worried, too, actually, because I like drug development--that managed care is making that more difficult; that it becomes harder and harder to break into a market.
But I am trying to figure out what the implication of what you were saying was. If the amount of a given drug, you know, say the drug is to treat hypertension is limited by the number of hypertensives, then you can't really increase that number except by having people use it for something else or something wrong. So what exactly is the thing we should be encouraging or doing in the mass marketing area? If it is sort of a zero-sum game for at least many things, then you can only take away from somebody else, except to the extent people are underserved or that certain drugs that should be used more are underutilized where everybody would probably agree that it is good to let people know they are there.
DR. SCHONFELD: Yes, well, I think in a lot of markets, a lot of consumers may not know a product exists to help them, or in some cases one of the big issues over the last few years has been the cost of drugs to consumers.
Well, if you can spread the development costs over larger markets, you know, ultimately you can price those products lower. Also, the rate at which a new product penetrates a market determines when you reach break-even. Again, it changes the economic cross-structure of launching that product. So if you have a long, long time to break even, a company may say, you know, I am not going to make that product; you know, we can't recover our development costs, or it is too risky.
However, if I can move the break-even point in closer in time by engaging in marketing activities, now that product becomes feasible. So even though the total size of the market may not necessarily be any larger, the timing of when things happen in the marketplace is not irrelevant.
MS. PEDERSEN: I have just one question for Ms. Golodner. When you were discussing the difference between print and broadcast media--and this is just to clarify because I am not sure I fully understood what you were saying--you talked a fair amount about the important information that you thought needed to be in print ads, and you talked some about the difficulty of 30-second and 60-second broadcast advertising.
Was the implication of that that you were not able to describe a way that you could see direct-to-consumer advertisements in the broadcast media? Or were there ways that you wanted to propose that it be dealt with in the broadcast media, different from print but still permissible?
MS. GOLODNER: I think it is difficult to get some of the messages that I had mentioned that are important. I think the risk information in the broadcast media--I don't want to just say blanketly that there should not be any advertising of prescription drugs over the broadcast media, but I think that FDA should look at it very seriously. If you do decide that there should be certain messages, whether or not it can occur in a 60-second spot, I think you will have to find out whether or not that can occur. I think it is very difficult to have all the messages that we are talking about on a 60-second spot.
MS. PEDERSEN: Any final questions?
We have a question from the floor. Dr. Ostrove will read it.
DR. OSTROVE: This is from someone from the floor, which speaks to the intersection of DTC and managed care. HMOs publish a lot of information for their members concerning health and treatment. Assuming that procedures that they don't cover or are very expensive and drugs that are not on their formulary will not be given any attention n these materials--and I'm specifically asking Ms. Golodner--is there another way to inform these partially informed members about other kinds of procedures and treatments aside from direct-to-consumer advertising?
MS. GOLODNER: I think consumers receive their information in a lot of different ways, and I don't think advertisers should think that they are the only messengers out there.
As soon as there is a breakthrough, it appears in JAMA or the New England Journal of Medicine, and USA Today and Washington Post and all the other media pick up on it immediately. And it goes into, you know, mass information for consumers.
People talk with friends and family about drugs that they hear are on the market. And I think that direct-to-consumer advertising is just one way that you receive information.
I am certainly aware that there are formularies within managed-care systems, and I think it is important for consumers to confront their own managed-care system and ask them if they can get a drug or they can't get a drug, and to really question their doctors. We encourage that discussion between the physician and the patient and pharmacists and the patient so that they can understand what drugs are out there and make informed decisions.
MS. PEDERSEN: Dr. Schonfeld?
DR. SCHONFELD: If I may make one comment? There is only one FDA-approved drug for kidney cancer. It is interleukin-2. Right now there is a major HMO in northern California that has never added interleukin-2 to its formulary. If you are patient in that HMO--I know of at least one case where they sent her home to fill out her will rather than treat her, the doctor there.
Now, that is a rather interesting question. How is that patient going to get information that interleukin-2 might be a treatment for her advanced kidney cancer? You guys got an answer for that one?
MS. PEDERSEN: Ms. Baylor-Henry would like to--
MS. BAYLOR-HENRY: Well, I don't know that I have an answer. I just want to add something.
Dr. Schonfeld, are your members active participants in the use of the Internet to exchange information?
DR. SCHONFELD: I would say a very small percentage. Many of them are much older. You know, they are in the 60s. They are not computer literate. So I would say the vast majority are not.
By the way, the Internet isn't free. You have to have an Internet service provider. You have to be reasonably computer literate to use the Internet, by the way. In fact, that is one of its big failings, that it reaches only technically elite. It does not reach poor, uneducated people.
MS. PEDERSEN: On that note, I think I'd like to thank the panel, Ms. Sander, Ms. Golodner, and Dr. Schonfeld, and to thank all of the participants who presented earlier today.
We will now recess until 8:30 tomorrow morning when we will reconvene.
[Whereupon, at 4:30 p.m., the proceedings were recessed, to be resumed on Thursday, October 19, 1995, at 8:30 a.m.]

top