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  • Geoffrey Levitt

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Reprinted with permission from the Food, Drug, Cosmetic and Medical Device Law Digest September, 1995 issue, Volume 12, No. 2, Copyright 1995 New York State Bar Association (1-800-582-2452), http://www.nysba.org.

Introduction

Consumers want information about matters that affect their health, including the drugs prescribed for their illnesses or conditions. Drug marketers want to give consumers such information. But the Food and Drug Administration (FDA) - the agency that currently regulates prescription drug advertising - has not made up its mind about how to regulate drug companies’ dissemination of information about prescription drugs directly to consumers.

The result is a sort of regulatory limbo in which drug companies advertise prescription products directly to consumers on the basis of an ad hoc “voluntary” system of FDA prior approval./1 That system, for the moment, is working adequately, at least in the sense that FDA appears to have tacitly accepted the inevitability of some direct-to-consumer (DTC) prescription drug advertising, and drug companies are getting an increasing number of such ads out into the marketplace. It is not, however, a rational or a stable system, and notwithstanding the players’ current modus vivendi, it is in need of re-assessment.

Regulatory Framework

DTC advertising as such is not addressed under either the Food, Drug, and Cosmetic Act (FDCA) or FDA regulations. Rather, FDA’s authority over such advertising is part and parcel of its authority over prescription drug advertising generally. That authority, in turn, derives from section 502(n) of the FDCA,/2 which requires that all prescription drug advertising include “such . . . information in brief summary relating to side effects, contraindications, and effectiveness as shall be required in regulations.”

On the basis of this provision, FDA has developed an extensive set of regulatory requirements for prescription drug advertising./3 Many of these requirements address, in more or less detail, the principal features that a prescription drug ad must have (e.g., warnings, precautions, contraindications, and the like). Other provisions spell out things a prescription drug ad must not do. Of particular importance for purposes of the present discussion, an ad violates section 502(n) if it is false, misleading, or lacking in “fair balance.”/4

When all these provisions were drafted, no one imagined that prescription drugs would be advertised directly to consumers. In fact, not long after DTC advertising first surfaced in the early 1980s, FDA was so uncertain about how to handle it that the agency - after an initially positive reception on the part of Commissioner Hayes - requested a “voluntary” moratorium, which lasted from 1983 to 1985./5 Five years later, a widely circulated internal FDA draft (1990 Proposed Draft Policy) proposed invoking the “extraordinary circumstances” provision of section 502(n) in order to require FDA pre-clearance of DTC ads, on the ground that the FDCA did not contemplate promotion of prescription drugs to lay consumers./6 Although the 1990 Proposed Draft Policy was never officially adopted, it reveals a great deal about underlying agency attitudes toward DTC advertising.

Current Policies

Currently, the agency recognizes three basic kinds of DTC communication concerning prescription drugs. The first consists of the so-called “see-your-doctor” or “disease-focused” messages. These do not mention a particular product; they simply describe a set of symptoms and suggest that consumers who have these symptoms see a doctor. In principle, FDA has no problem with this kind of communication, and in fact does not consider it to be drug promotion at all. Companies that FDA perceives as trying to slip statements about their drugs into these “see-your-doctor” messages, however, run the risk of being taken to task by the agency.

The second kind of DTC communication is a simple “reminder” ad that merely mentions the name of a product without any discussion of what disease or condition it is indicated for or what its benefits may be. FDA, is, in principle, comfortable with this kind of communication, as it is with the “see-your-doctor” message discussed above. Of some practical relevance to advertisers, reminder ads do not have to carry the “brief summary” of information otherwise required by section 502(n). This means, among other things, that such ads may lend themselves to mass market television, where no one has yet been able to figure out how to comply with the “brief summary” requirement in a practical way.

It is the third category of DTC ads, however, that is by far the most interesting. These are ads that discuss the benefits of a specific prescription drug product - “drug X, for gout.” FDA makes no secret of the fact that it looks at this kind of DTC ad with extra intensity.

The agency has raised several sorts of health policy concerns about such DTC advertising. Probably the primary such concern centers around the view that lay consumers, unlike physicians, lack the ability to understand prescription drug claims in proper context, and are therefore excessively prone to being misled by such claims. Allied to this is the concern that consumers may misuse the drug based on a misunderstanding of specific information in an ad. The 1990 Proposed Draft Policy stated: “The reason prescription drugs are so classified is precisely because consumers lack the ability to make independent diagnostic and treatment decisions regarding such products . . . ironically, the more information that is conveyed about a drug to medically untrained populations, the greater is the chance that people will be misled about specific characteristics of the drug.”/7 Another set of concerns relates to potential intrusion on the doctor-patient relationship. In this view, DTC ads may subject the physicians to outside pressures to prescribe particular products, improperly influencing his or her professional judgment, and may encourage “doctor-shopping” or excessive prescribing.

It seems that there remains a deep skepticism in certain quarters within FDA about whether DTC advertising can serve any proper function at all. In this view, the only “legitimate” function of prescription drug advertising is to communicate medical information about drug risks and benefits to health care professionals. Because lay consumers are incapable of accurately understanding such information, the argument goes, DTC advertising is left with only the “illegitimate” function of trying to increase product sales. The 1990 Proposed Draft Policy, for instance, stated that “the goal of individuals and organizations supporting [DTC] advertising is primarily to increase sales of their products. Given this goals, [we are] convinced [the] long-term, cumulative effects of DTC ads would be detrimental to the public health.”/8 Along similar lines, a senior FDA official has referred to DTC advertising this way: “Unfortunately, most of the direct promotional efforts by drug manufacturers are primarily aimed at gaining a greater share of an already crowded market . . . . In general, we are not in sympathy with the industry’s direct attempts to persuade patients that they need a certain form of therapy.”/9

More recently, however, there are signs that the FDA is becoming more comfortable with DTC promotion. The last year or so has seen a number of DTC ad campaigns that are unprecedented in their scope and detail. There is talk of FDA’s finally providing the industry with some kind of coherent regulatory guidance on DTC advertising./10 And FDA officials involved in regulating DTC promotion have begun to talk publicly about some of the rules of thumb they use in judging the appropriateness of a DTC ad. Among these rules are avoidance of the terms “safe” and “effective” (evidently on the ground that lay consumers lack the ability to understand these terms fully in context); avoidance of comparative claims relating to features other than consumer preference factors; and inclusion of negative information about risks, side effects, and the like in order to properly counterbalance positive information about the drug’s benefits./11

Some Counter-Trends

Ironically, just as FDA is starting to get used to DTC advertising, the agency’s control over that advertising is being challenged in various ways. The notion of shifting jurisdiction over DTC advertising from FDA to the Federal Trade Commission (FTC) - which already regulates over-the-counter drug advertising (and advertising of most other categories of consumer products as well) - is becoming increasingly prominent, and has gained a number of adherents in Congress./12 Much of the sentiment behind this notion stems from two premises: that the FTC has much more experience and expertise in interpreting and overseeing consumer advertising than does FDA; and that FDA’s generally conservative policies on DTC advertising have prevented useful information from reaching consumers. And FTC staffers have also spoken publicly about their own growing interest in DTC advertising, though disclaiming any intention to take official action in this area./13

While FDA’s institutional ability to handle FTC advertising is thus under challenge, broader trends in the prescription drug industry may be starting to chip away at the significance of DTC advertising in the conventional sense altogether. Most notably, the rise of health maintenance organizations (HMOs) and pharmacy benefit management companies (PBMs) means that the traditional model of an independent, unattached patient walking into the doctor’s office of his or her choice and asking about a particular prescription drug by brand name - the model upon which much DTC advertising is predicated - may become less widespread. If a drug isn’t on the formulary administered by the patient’s HMO or PBM, advertising that drug directly to consumers may have relatively little practical impact. And as pharmaceutical companies’ attention increasingly shifts toward their all-important relationships with PBMs, their interest in DTC advertising may also begin to wane somewhat.

Nonetheless, the potential benefits of DTC advertising from the drug marketer’s perspective are such that this form of promotion is likely to remain very much of an issue on FDA’s regulatory agenda. A critical assessment of FDA’s policy on this issue is therefore in order.

Toward a Sounder Policy

FDA’s traditional distaste for DTC advertising starts from an unexceptionable premise - that prescription drugs are fundamentally different from most other consumer products because lay consumers on their own presumptively lack the expertise to make final decisions about whether to buy and use the product. But this traditional view then goes on to an exaggerated set of conclusions based on this premise - namely, that providing specific information about prescription drug products to consumers is not a good idea.

In fact, however, there is no inherent reason to conclude that a less informed consumer makes a better, more compliant patient than a more informed consumer, and no evidence to support such a conclusion either. Even accepting the notion that consumers should not ultimately be making their own prescription drug choices, there are still particular attributes of prescription drugs that may be of direct interest to consumers, and readily understandable by consumers - for instance, dosing frequency, or the appearance and comfort of a transdermal patch. And while other kinds of information - such as the details of a drug’s pharmacodynamics - may be beyond the comprehension of much consumers, basic information about a product’s intended uses (and risks) usually should not be. Such information could, in fact, be of considerable benefit to the consumer - for instance, in cases where the consumer may be called upon to make an informed choice about whether to begin long-term therapy with a particular drug (for instance, hormone replacement therapy for postmenopausal women).

More broadly, it is a central tenet of the free market system that providing product information to consumers - as long as that information is truthful and nonmisleading - is good for competition, and good for consumers. If that holds true for toys and tires, it must be at least equally true for prescription drugs, whose direct impact on health and well-being is as great as that of any product a consumer is likely to encounter in his or her lifetime.

Whether jurisdiction over DTC advertising stays with FDA or not, these realities can and should be taken into account in thinking about where to go from here, as should drug marketers’ right to communicate truthful and nonmisleading information to the public without excessive regulatory restrictions./14 Careful scrutiny of DTC advertising is certainly warranted in light of the often complex and sensitive health issues that such advertising addresses. And it is certainly legitimate for FDA, in examining the content of a DTC drug ad, to take into account that the ad is directed toward lay consumers rather than health professionals. But the fact that lay consumers may lack the requisite knowledge to decide whether to prescribe a drug does not mean they are incapable of accurately understanding prescription drug advertising per se. Rather, the proper inquiry with respect to a DTC ad is whether the actual content of such an ad renders the ad false and misleading. If not, then FDA can and should leave it alone.

ENDNOTES
  • See Pines, Some Major Issues in Direct-to-Consumer Advertising, 49 Food and Drug L.J. 589, 590 (1994).
  • 21 U.S.C. &#sect; 352(n).
  • 21 C.F.R. &#sect; 202.1.
  • 21 C.F.R. &#sect; 202.1(e)(5).
  • See, FDA, Statement of Policy: Direct-to-Consumer Advertising of Prescription Drugs: Moratorium (September 2, 1983).
  • Memorandum from Director, FDA Center for Drug Evaluation and Research, to Acting Commissioner, Re: Direct to Consumer Advertising of Prescription Drugs (July 17, 1990).
  • Id.
  • Id. (emphasis added).
  • Carol R. Scheman, FDA, Remarks at Drug Information Association Workshop (November 18, 1992).
  • Direct-to-Consumer Ad Guide Gaining Priority at FDA, Washington Drug Letter, January 30, 1995, at 1. In addition, FDA has now announced that a public hearing, to be held on October 18-19, 1995, will address issues and concerns relating to DTC prescription drug advertising.
  • Ostrove, Issues Related to Direct-to-Consumer Promotion of Prescription Drugs, slides presented at a Food and Drug Law Institute conference (September 12, 1994).
  • See FDA CME Policy “De-Funding” Advocated by House Budget Committee, F-D-C Reports “The Pink Sheet,” May 22, 1995, at T&G-1.
  • “Rx Direct-to-Consumer Ads Attracting FTC Notice,”F-D-C Reports “The Pink Sheet,” March 13, 1995, at T&G-10.
  • See, e.g., Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557 (1980).