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Transcript of Direct-to-Consumer Promotion Public Hearing - Panel 3




MS. PEDERSEN: The next panel will be comprised of Paul Rubin and John Calfee. We will start with Dr. Rubin.
DR. RUBIN: My name is Paul Rubin, and I am a professor of economics at Emory University. The views I am expressing are solely my own. My travel expenses were paid for by the Progress and Freedom Foundation with which I have an association. I am a member of the Medical Innovation Project Advisory Committee, but the views are my own, and that association entitles no compensation except for the expenses.
My employer is not engaged in any of those things. I am appearing as an individual. I have on occasion, since 1992, consulted for drug companies in a relatively minor way, but nothing I am saying now is related to that.
As I said, I am a professor at Emory. I have written several articles on the topic of prescription drug advertising, including an early article in the New England Journal of Medicine, which the FDA cited in an earlier decision. I have also served as a senior economist in the Advertising Division at the Federal Trade Commission, so I have had experience regulating advertising at a related agency.
I am going to first make some general points and then address the specific questions more directly.
The focus of the discussion in the notice is on required disclosures. Five of the questions refer directly to disclosures, and the others implicitly deal with the issue.
The implicit belief seems to be that drug companies will, if left alone, conceal relevant information from consumers. The entire thrust of the discussion is on ways to compel disclosure of information viewed as useful by the regulatory authorities. In my view, this approach is flawed for two reasons: first of all, it ignores the role of the physician in the prescribing process; and, second of all, there are incorrect assumptions about the incentives and behavior of firms in the industry.
First, the physician. We have to remember that the consumer cannot decide to purchase or use a pharmaceutical. All a consumer can do is decide to ask a physician about a prescription for a pharmaceutical.
Direct-to-consumer advertising is valuable precisely because different actors in the pharmaceutical prescribing system sometimes have different pieces of information. It is valuable in circumstances where the patient, for whatever reason, is not in contact with the physician but where medication would be useful. And the literature, including my own work, has identified numerous examples. We heard some this morning. I don't think I will go through those, but it is especially important to point out that this type of information, information that may be provided in advertising, is most useful for relatively less educated, less informed consumers. So we heard references this morning to consumers reading various medical publications, and that is fine for people such as those in this room. But research by people at the FTC and other places has shown that most consumers don't read such publications, that most consumers would get much more information from advertising and other sources of publicity.
So there are various uses of drugs. One important example are drugs which may have reduced side effects. Consumers may have stopped taking medications or may not be in contact with a physician, and ads can indicate the reduced side effects. Other examples, of course, are just common things, common ills of people: athlete's foot, asthma, sleeplessness--some of us may pay more attention to baldness than others--the value of nicotine chewing gun for quitting smoking. These are some of the simple examples.
But the key point is that the physician must always be consulted and the physician will have access to any information about risks or contraindications. Even if consumers are given some information through advertising, the physician still has the additional information, and in a sense there is not much point in making sure that both parties have all of the information. The consumer can take information about his own conditions, combine that with information in the ad, approach a physician and say, Is this medication appropriate? And the physician will know risks and contraindications and can make that decision.
Indeed, it is odd that there is so much regulation of direct-to-consumer prescription drug advertising because deception is less likely here than in almost any other market. If an ad is misleading, the physician can simply refuse to prescribe the medication. Advertisers have no incentive to advertise products which physicians would refuse to prescribe.
The only cost of any consumer misinformation may be the cost of a needless visit to a physician, but we would expect the expected cost of this in general to be less than the expected cost of foregoing treatment for many of the conditions for which advertising could occur.
The next thing to think about is the incentives of firms when it comes to provision of information. Now, we heard people say that firms are not out to provide information; they are out to sell products. And, of course, that is quite right. In a market economy, we rely on incentives of firms to sell things to provide all the goods and services that we consume, and information should be no other. We should remember we are functioning in a market economy, and that is the basic driving force, and there is no particular reason to treat information as being particularly different.
The flaw I observe in the Federal Register notice and, indeed, in the FDA's current regulations of promotion is the implicit assumption that the information manufacturers would provide in a relatively unregulated environment would be different than the information valued by consumers. The assumption is that manufacturers would conceal valuable information from consumers if they could do so. This is, for example, behind the requirements for fair balance in the FDA's regulation.
This implies that the government in the form of the regulators at the FDA can do a better job of determining what information is valuable than can producers and consumers. And I think it is fair to say that the view that government is wiser than the marketplace is today under increasing attack, and I think in the FDA context it is relevant as well.
There is a large literature in economics indicating that advertisers do best by providing valuable and truthful information to consumers. Again, not because advertisers want to provide valuable and truthful information--advertisers want to make money--but advertisers can make more money in the general case by providing this sort of information.
The implicit assumption behind the regulations is that, without restrictions, manufacturers would present only favorable information, which seems plausible but, in fact, is incorrect. Advertisers commonly and routinely present negative information about their wares because it is often in their interest to do so. If an advertiser can claim that his product has less of an undesirable characteristic than other products, then it may pay to advertise the amount of this negative characteristic. It is because consumers will rationally assume that a product which does not advertise the value of a critical piece of information is among the worst products with respect to that information.
If you see an ad for a product without price, your natural assumption is this is a high-priced firm. If you see an ad for ice cream that doesn't mention fat content, you might think it is a high-fat ice cream. If you see an airline who doesn't mention its on-time rate, a rational assumption is that that airline is maybe later than most.
So, in all cases, manufacturers with better levels of the relevant characteristic do advertise, and the same thing is true in drugs. As I said before, a very important form of advertising of drugs is reduced side effects: Our product is not as bad as others in this negative characteristic. The campaign for an antihypertensive, less likely to cause impotence. Less frequent dosing, more convenient forms of medication were things that were mentioned this morning. Again, negative characteristics but an ad saying our drug is easier to take than other people's drugs.
The problem I have with the questions and with the FDA's current policy is that it is area-deceptive. The FDA sometimes views any advertisement as deceptive unless it contains a fair balance, and this means that any message promoting some pharmaceutical must also present virtually all negative information about the product as well. But, again, the ads are aimed in part at physicians, and physicians would have this negative information. And, again, manufacturers also have incentives to provide relevant amounts of information, just as every advertisement for an automobile would be required to have prominent information about risk of death or injury in an accident, a side effect, and about dangers of driving under the influence of alcohol, a contraindication. So this is what the FDA now requires, and I think it is harmful.
To talk about the specific--well, let me just say there is also a lot of evidence from economists studying stock market reactions to deception that firms that are accused or convicted of deception, for example, by the FTC lose very substantial amounts of stock value, so there is a very strong incentive there as well to maintain the reputation not to do things that will be viewed as deceptive.
Specific questions: What is known about the effects? Direct-to-consumer promotion can provide consumers with information about medicines that would otherwise not be available. Such information will serve to increase the public health. In addition, direct-to-consumer promotion is likely to lead to lower prices for pharmaceuticals. In most markets which have been studied, increases in advertising have led to reduction in prices because advertising forces firms to engage in more competition, and this would be particularly likely for prescription drugs since the physician who makes the decision does not pay for the drug and has little incentive to consider cost. Giving consumers additional information would lead to increased incentive to price shop, and there are several kinds of information that consumers could get for price shopping. This would reduce price and would lead to increased compliance, and so would increase the public health.
Does direct-to-consumer promotion oversimplify? Again, the safety and effectiveness information is not so relevant because the physician will have this information, and we don't need to rely on an ad to provide all of the information to consumers.
Can consumers understand and assess claims? This is where I think we have to look at manufacturers and advertisers. It is in the interest of manufacturers, the sellers of drugs, to provide information that consumers will find useful and valuable. Manufacturers can benefit from promotion only if consumers understand the message in the materials, and advertisers are better at knowing what sorts of messages will be useful to consumers than is a government agency. I know the FTC was not particularly good at knowing those kinds of things, and I see no reason to think the FDA is better. So I think we could rely on advertisers to understand what information is valuable.
Because an important characteristic of a pharmaceutical may be reduced side effects, it is important that comparative promotion not be discouraged. Consumers may not mention side effects, may have stopped taking medication, so ads comparing drugs and saying ours has less side effects could be particularly valuable and should not be discouraged.
Reminder ads, these exist, as I understand it, primarily because of the brief summary requirement. Since that policy is misguided, it is likely that when the FDA eliminates it, there will be many less reminder ads, but, again, as long as firms find them worthwhile, we should not try to intervene and say, well, we know better than firms what kinds of ads are worthwhile.
We have heard a lot of discussion about the brief summary. In print advertising the effect, of course, is to increase the cost of advertising. And economists know that when we increase the cost, we get less of something. Since advertising is useful, increasing the cost is undesirable. For TV advertising it is even more harmful because, as people have remarked, we don't get very much TV advertising because of the brief summary requirement. And as I said before, TV advertisement is particularly important for relatively less educated consumers, so what we are doing by requiring a brief summary is keeping people who are less educated and maybe less likely to be in contact with a physician, we are making it more difficult for them to learn about new therapies.
New technology has spurred the growth of computer-based promotional vehicles. Well, since I think the disclosure requirements are not valuable in print or broadcast, if we view electronic technologies as a hybrid, I see there is no value there either.
In the case of infomercials, it may be desirable to require that they indicate that they are paid advertisements, but I would not go much beyond that.
Fair balance, critical messages, the same point. In addition, when it comes to critical messages, it is well known that consumers have difficulty absorbing information about low probability events, such as most side effects. The fact that a medication has been approved by the FDA indicates that, at a minimum, net benefits are greater than harm, some of us think much greater than harms, including side effects. So if FDA requirements then lead consumers to believe that side effects are more likely than is actually the case, the effect of the required disclosures is likely to mislead consumers to their detriment, and we heard some research on that point this morning. So I think this requirement also provides no net benefit.
Manufacturer-supported direct-to-consumer promotion appears to be sponsored by independent third-party services. Disclosures are risky here. It may well be that a third-party independent agency has determined on its own that a prescription drug is useful for its disease. If we then require disclosures, it may lead the independent agency not to accept the money from a pharmaceutical company and may lead to less dissemination of information. So, again, I think it is very important that we always--and this is my key point, then I will stop--that we always consider in these matters not only whatever costs of deception we may think exist, but also consider and put at least equal weight on the cost of the lost information and the reduction in public health that may come about by overly restricting advertising.
Thank you.
MS. PEDERSEN: Thank you, Dr. Rubin.


Dr. Calfee?
DR. CALFEE: Thank you. I am Jack Calfee. I am with the American Enterprise Institute in Washington, D.C. I am here under the auspices of AEI or as an AEI scholar. My views are completely my own. They don't represent AEI or anyone else.
I have done at some point, I am sure, some tiny amount of consulting for pharmaceutical firms. It has been extremely limited.
AEI receives substantial contributions from pharmaceutical firms, although I really don't know how much, nor do I know the views of most of those firms on any of the issues that I am going to be talking about. That is all I can think of in the way of disclosure.
I have covered my own travel expenses from Bethesda to Silver Spring.
I have a short statement, short enough that I think I will just read it, and see what you think.
After some two decades of debate and experimentation, the potential benefits of direct-to-consumer advertising of prescription drugs are well established, if not completely accepted. Less agreement has emerged on the potential risks of direct-to-consumer advertising. This, in my opinion, is unfortunate. There is compelling evidence that these risks are small, certainly smaller than the benefits of direct-to-consumer advertising.
Most analyses of this kind of advertising assumes that advertising poses risk because the drugs they advertise are risky. I believe this starts off on the wrong foot. Direct-to-consumer advertising tends to reduce consumer risk by alerting consumers to less dangerous alternatives to their current treatments, reminding them of the importance of compliance, and, most important, guiding untreated consumers to drugs that are less risky than the illnesses they treat. We should, therefore, bear in mind that pharmaceutical ads, including those directed towards consumers, are largely a mechanism for reducing consumer risk, even if consumers encounter new risks associated with the drugs being advertised.
Nonetheless, the question of how direct-to-consumer advertising affects consumer perceptions of pharmaceutical risks demands attention. I would suggest that evidence from the research literature falls into two broad categories: research on risky products other than pharmaceuticals, and research on pharmaceutical advertising itself.
So let me say a little bit, first of all, about advertising in risky products generally, not necessarily pharmaceuticals.
Consumer markets are full of heavily advertised risky products ranging from paints, stepladders, baby cribs, and automobiles. On the whole, these markets have served consumers well. Many of these products actually reduce consumer risk without entirely eliminating it, and the dominant aspect of competitive markets is product improvement, especially in the realm of safety.
This experience yields important lessons. There is little, if any, evidence that advertising, including advertising that fails to mention safety or risk, lulls consumers into discounting risk. Advertising has been a force for product change, including changes that reduce risks. And examples would include healthier foods, safer home heating systems, electric appliances, automobile tires, brakes, and lights, and many others.
The mechanism for such improvements has typically not been direct appeals to safety. More common are indirect methods such as the introduction of a safer product accompanied by an implicit threat to make safety an issue if competitors do not quickly follow. Again, I would say automobile tires provide a good example of this dynamic process.
When competitors will not or cannot keep up, however, health-related advertising can quickly move consumers towards safety, as has happened with many over-the-counter drugs such as analgesics. Consumer attitudes have also played a fundamental role, especially skepticism toward advertising and the consumer's assumption that a brand that fails to address a potential weakness is probably subject to that weakness.
Consumers use advertising rather than being used by advertising, and they combine sparse information in advertising with plentiful information elsewhere, especially when dealing with such central issues as health and safety.
Market experience with products other than prescription drugs has, therefore, demonstrated a remarkable robustness in consumer advertising and information, especially where consumer risk is involved. Competitive forces have moved information and products in the direction of reduced risk. Advertising has been one of those forces. Except where the FDA is involved, regulation has almost never required advertising to be a vehicle for conveying balanced and complete information about risk. Yet the effect of this advertising has been anything but to undermine consumer awareness of the risks of inherently dangerous products. Any suggestion that current FDA regulations for direct-to-consumer drug advertising must be maintained or strengthened fails to take into account abundant evidence from parallel markets.
Now, on advertising in prescription drugs themselves, the research literature on consumer information about prescription drugs is small but compelling. A useful exercise is to look at two extremes in the marketing environment. International experience can tell us what happens when consumer markets are nearly unregulated. Many drugs that require a prescription in the United States are sold over the counter in undeveloped countries. In these nations, antibiotics and other potent drugs are sold to uneducated consumers by non-professionals, even by untrained kiosk clerks located far from any physician's office. These circumstances should test the limits of the robustness just described by me in the interactions among buyers and sellers of risky products. If advertising and promotion do not undermine consumer risk perceptions in this environment, they are most unlikely to do so in the far more protective environment of the United States.
Yet consider Professor Sam Peltzman's path-breaking work in the 1980s in which he compared the effects of selling potent pharmaceuticals by prescription in the U.S. with the effects of selling the same drugs over the counter in underdeveloped nations. He found no protective effect from the very strong U.S. requirement that consumers obtain a physician's prescription before purchase. He concluded, and I quote, Increasing the spectrum of risk available to the consumer does not increase the actual risk consumers choose to take. Relatively unsophisticated--and I would say very unsophisticated--drug consumers in other countries tend to choose less risk, even when they can buy almost anything over the counter. Other research, less systematic but still informative, has found similar patterns in the marketing of valuable but potentially deadly drugs in Third World nations. Consumers pick and choose with careful attention to the risk of pharmaceuticals regardless of whether they see advertising and promotion that lacks detailed risk information.
At the opposite end of the research spectrum are controlled experiments and surveys that directly address how consumer perceptions are affected by risk information, if any, in prescription drug advertising. A prominent example is a series of studies by FDA consumer researcher Louis Morris, who is here today and listening to this, and his colleagues. Their research has directly addressed how consumer perceptions are affected by risk information, if any, in prescription drug advertising.
This research stream has consistently shown that consumers tend to regard prescription drugs as risky and worthy of caution regardless of whether the ads included detailed risk information contained in the brief summary that is now required for brand-level ads making therapeutic claims.
These research streams and much more research on other products provide clear lessons. It is a fundamental error to assess the state of consumer information by looking at the ads that consumers see. This applies particularly to products whose risks are complex and difficult to summarize. Neither intuition nor experience suggests that consumers expect advertising to be the vehicle of risk information. They expect advertising to serve a traditional, partisan, and unbalanced role. They assume drugs are risky regardless of whether advertising discusses risks, and they turn to other sources for reliable medical information. They use advertising as a tool for requiring the types of information that competing sellers have an incentive to provide, and they use this information for their own purposes.
This overtly competitive process has not served to undermine consumer understanding of risk. Rather, it has proved to be an effective mechanism for improving consumer information, including information about risk, in bringing better consumer choices.
Finally, very briefly, regulatory implications. The implications from research on diverse markets is clear. Regulations should focus on the truthfulness of advertising claims rather than on the completeness of information in advertising. Any requirement for complete and balanced risk information threatens to suppress useful advertising for prescription drugs. This advertising has not distorted consumer risk perceptions, but instead has proven to be a valuable tool for consumers wishing to reduce their own risk.
Amanda, you said you would welcome some extra time, and so I just gave you some.


MS. PEDERSEN: Thank you very much.
Are there questions for either Dr. Rubin or Dr. Calfee? Mr. Schultz?
MR. SCHULTZ: I have some questions for Dr. Rubin. I gather from your testimony you think that the FDA has too many regulatory requirements in this area.
DR. RUBIN: I think that is a fair judgment.
MR. SCHULTZ: And would you apply that also to advertising directly to physicians, that you think there are too many regulatory requirements?
MR. SCHULTZ: And you probably don't think that there ought to be a fair balance requirement for the advertising to physicians either. Is that right?
DR. RUBIN: Well, I think physicians have access to information that would give them whatever they want. I think the effect of the requirement is to increase the cost of ads.
MR. SCHULTZ: So you don't think that is a useful requirement?
DR. RUBIN: I think that is right, yes.
MR. SCHULTZ: And what about when the FDA approves a drug? The labeling, the FDA requires that the labeling contain certain information about adverse reactions and risks and warnings. Do you think that is probably overdone as well, I assume?
DR. RUBIN: I must say I haven't thought about that issue in detail, so I wouldn't--
MR. SCHULTZ: And what about the requirements that drug companies, before they advertise a claim, they actually get the claim approved by the FDA and present the FDA with their data? Do you think that that is an unnecessary requirement?
DR. RUBIN: Well, I think there has been a lot of discussion of that. I think it probably is, especially since the evidence I have seen indicates that it takes as long to get a secondary claim approved as the first claim, and since patent life is shorter, people often don't get that kind of information approved. So I think there is very valuable uses, and it is quite costly not to allow that information.
MR. SCHULTZ: Given your statement, which is that the market incentives are such that the advertisers are naturally, according to you, going to provide information and the market is going to sort of lead to accurate information, it doesn't surprise me that you would think that there really isn't a role for the FDA in approving claims.
DR. RUBIN: Approving claims ex ante. Again, there is a role for someone in looking at deception. I have no problem with someone regulating--
MR. SCHULTZ: After the fact.
DR. RUBIN: Explicit after-the-fact deception.
MR. SCHULTZ: Not before the fact. What about the requirement that prescription drugs be basically approved by a physician before they are sold to the consumer? Do you favor that or do you think that is unnecessary as well?
DR. RUBIN: I haven't done any research on that myself. As my colleague mentioned, Sam Peltzman found in, as far as I know, an uncontested paper--although there may be some literature that I am not aware of--found that in countries that did not have that requirement, there was no evidence of harmful effects. I have read that paper, but I haven't studied it carefully, and I haven't looked for any follow-up literature.
MR. SCHULTZ: So you don't have a position on whether we ought to have prescription drugs--
DR. RUBIN: I don't have a professional position.
MR. SCHULTZ: Okay. Thank you.
MS. PEDERSEN: Dr. Temple?
DR. TEMPLE: Dr. Rubin, I heard two arguments. I want to tease out which you think is most important, or maybe you think they are both important. One was what is commonly said about direct-to-consumer advertising, that it doesn't matter particularly because the physician is there to keep anything bad from happening. Many people have said that, and that certainly makes sense. You also, I think, in a sort of belt-and-suspenders way, said we also don't need to worry because advertisers have an incentive to be thorough, to tell the truth, to be balanced, and all that. And I guess I wanted to pursue how important that aspect of it is to the argument for you because, as we review prescription drug advertising, it is perfectly common to see it be unbalanced in various ways. We have many examples of that. Although if you were to say people don't usually leave out death-dealing things, I think I would agree with you. I think nobody wants to do that.
But in the interstices where something might be a little better, might not be a little better, there is plenty of unbalance. But does that matter or not? How important is it to you that we believe the second of those two arguments?
DR. RUBIN: In this context, of course, we could rely on the first argument. My own belief is the second one is probably at least as important. I think what I meant to say was that manufacturers provide information they find useful, but as Jack emphasized, people reading these ads also know that they are provided by an interested party. And to say each ad for each product must give all the information I think underestimates the power of the marketplace.
One manufacturer may not provide what the FDA views as fair balance, but clearly other manufacturers have a strong incentive to say in their ads, if they are allowed to do so, we are better on this characteristic, we have this to a stronger extent.
So I think the marketplace is quite powerful in--not in each ad, and I think that is a mistake that people make, to say each ad as if consumers only read one ad and nothing--or physicians only read one ad and nothing else. But I think if we rely on the marketplace, there would be quite a substantial amount of information provided in the most useful form.
DR. TEMPLE: So it will be sort of self-correcting if somebody says I have fewer of these, I don't cause impotence, the other company will say, yes, but you cause diarrhea, and they will go back and forth, and eventually it will all come out okay.
DR. RUBIN: That sort of process. That is the process we rely on for all other products, and it seems to work in the sense that we are--you know, we have lots of products that work quite well.
DR. TEMPLE: I guess it sort of works, but when I want to buy a car, I go to Consumer Reports. I don't look at the ads.
DR. RUBIN: That is fine, and I have no problem with your going to Consumer Reports, which is a private service that people find valuable. The point is, though--and let me just--you and I are more likely to read Consumer Reports than some other people, and to say the market--you know, we are going to rely on Consumer Reports because everyone can read it I think is a fallacy that we hear in Washington and may sometimes undertake, because some people don't.
MS. PEDERSEN: Other questions? Mr. Schultz?
MR. SCHULTZ: This is for both members of the panel. I think it is one thing to say, look, in this country we allow this kind of advertising for most other products. Now, let's look and ask the question of why are we treating this product differently. That is sort of one kind of argument. But the other kind of argument that I hear is that this advertising is actually very useful, and the consumers will actually benefit from it. And I think that is much more difficult, and I would ask whether either of you know of any studies with regard to over-the-counter drug advertising, which is the closest analogy I can think of, where we had this kind of advertising for a long time that would suggest that there actually are consumer benefits, that this sort of information that is useful to consumers that you both have sort of hypothesized we might get if we allowed this advertising for prescription drugs actually is conveyed and it actually does change consumer behavior in a way that is useful.
DR. CALFEE: Well, I think it is regarded as almost a truism in the marketing community that the process by which consumers became aware of the risk of aspirin was largely a result of the encouraging of OTC competitors to aspirin, specifically acetaminophen in the various brand of products; and that it was Tylenol that first told consumers that aspirin was harmful to the stomach. I think there are many examples like that, but--
MR. SCHULTZ: Are there others? You did mention that in your statement, but are there any other examples, any other studies? When you consider billions of dollars of over-the-counter drug advertising, that is one example.
DR. CALFEE: Not having reviewed this stuff, I am not going to be able to give you an answer right off the top of my head. It would be utterly stunning if it turned out that OTC drugs are an exception to the dominant pattern that has been found in product after product after product, which is advertising is a vehicle by which you get products that are better and cheaper and more improved.
DR. RUBIN: I guess I would sort of turn the question around, and I start with the presumption that in a society with a First Amendment, if we are going to interfere in provision of information, then the burden of proof may be on those who say this interference is going to be helpful. And I haven't seen studies showing that--
MR. SCHULTZ: I understand that argument. I do understand that. But I just would ask if you do have any information, when you go back to your offices you are able to identify actual studies outside the aspirin example of over-the-counter drugs, I think it would be useful to us as we work through this. I would just ask that you submit it.
MS. PEDERSEN: Dr. Sundlof? The last question.
DR. SUNDLOF: Yes, I will address this to Dr. Calfee. You indicate that communicating risk is not an important part of the advertising. Let me just ask you about a different scenario and ask how you feel that the FDA's role might be in advertising.
We have a problem in which the resistance develops to certain drugs, especially antibacterial drugs, and the promotion of these drugs for uses that may not be essential to use that particular drug, there are other alternative drugs that don't bring up this resistance issue, to allow advertising of those drugs that we need to keep in reserve, without communicating that risk back to the public, so that the public's use, the individual who uses that drug may benefit directly from that drug, but by that individual using that drug it may adversely impact on the public in general.
DR. CALFEE: You are hitting on a really fundamental problem, which is a problem not just with antibiotics but with other things, such as vaccines, which is that there is an economic externality that the benefit to me of using a drug, you know, may cause problems with other people. That is why if I knew that everyone else in here was getting vaccinated for a particular illness, I might avoid the vaccination because I don't need if it everyone else is getting it. And that can play out in a very adverse way, as we all know. And we know we are getting some serious problems with antibiotics.
I would suggest that to the extent there are alternatives to using the cheapest--I mean, I am not a physician, so I don't know the ins and outs of all this. I understand that in some cases, according to an article I read very recently--I don't know if it was the Wall Street Journal or someplace else. There was a long article I am sure a lot of you saw on this issue. My understanding was that in many cases physicians would prefer to use a drug that decreases the likelihood of some of these adverse developments. In other words, stop using Drug A because its continued use is developing resistant bacteria, and instead use Drug B, but Drug B costs more. And it is difficult to get this through the approval process, managed care, whatever, and I would suggest that at least in some of these cases, a freer advertising environment might be able to emphasize the value of certain drugs, emphasize the value of certain drugs in preventing the development of resistant bacteria and, therefore, might contribute to the problem.
But I will be very frank with you. I don't know enough about the specifics of these things to form a strong opinion on that.
Could I mention one other thing?
DR. CALFEE: Regarding the fair balance, which Bill Schultz and other people were mentioning, I think we should bear in mind that so long as unapproved uses are kept off the label and kept out of ads, we can be sure that for a large proportion of our drugs, the no-FDA-approved statement is going to present a fair balance of the costs and benefits of using these drugs.
MS. PEDERSEN: Thank you, Dr. Calfee and Dr. Rubin.



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