lay press that generate demands for drugs than about articles that appear in the scientific or medical press.

The physical location and ambience of the symposium are also factorsthough not deciding ones-in judging whether a symposium is educational or promotional. Specifically, the FDA will examine whether the symposium provides participants with educational information primarily or as an adjunct to promotional activities. In one case, the FDA concluded that an event was promotional partly because the presentation took place at a cocktail and buffet reception. In addition, noneducational inducements such as meals, travel, and entertainment make the presentation more likely to be viewed as promotional." The FDA also distinguishes between a single scientific symposium and a "road show" series: multiple symposia on the same subject are likely to be viewed as more promotional than scientific. If a speaker makes a promotional statement at a symposium, the FDA expects the sponsoring drug manufacturer to warn the speaker against repeating such statements at subsequent meetings. Employees of the pharmaceutical firm may participate in a symposium, but their presentations need to be limited to data they alone can present. Finally, publications that emanate from the symposium that are distributed by the drug company are regarded as labeling and must comply with the agency's regulations."

If a study that suggests particular indications for an investigational agent is discussed at a seminar sponsored by a pharmaceutical firm, and if that seminar is deemed promotional rather than educational, such discussion is per se a violation of existing FDA regulations." Not only is promoting the value of unapproved drugs or unapproved indications at manufacturer-sponsored promotional seminars prohibited, but speakers at such seminars are prohibited from making presentations that are false, misleading, or lacking in fair balance. The first FDA regulatory action in this area involved a physician's presentation to a seminar that was sponsored by the manufacturer of a bronchodilator and was attended by representatives of various pharmaceutical associations. The FDA charged that the firm inappropriately engaged in efforts to promote its product as superior to other bronchodilators.

The agency also took regulatory action against the pharmaceutical sponsor of a special supplement to a medical publication presenting the results of an unblinded study, funded by the sponsor and conducted by 54 office-based inves

tigators. The study concluded that a certain nitroglycerin transdermal infusion system was superior to another product. The FDA held that the supplement was promotional material and was false and misleading, because conclusions were drawn from inadequate and poorly controlled data and because the sponsor failed to give weight to conflicting studies."

3.64.57.70

The agency has expressed similar concerns about promotional materials packaged as medical publications." Citing a publication's sole sponsorship by a drug company and the questionable independence of its editors (who had served as investigators for the firm), the agency recently took action against a publication that it concluded was labeling. Because an article in the publication suggested that one of the sponsoring company's drugs was useful in treating conditions not included in the product's labeling, the publication was considered to violate the Act." In contrast, discussion of nonapproved uses by an independent investigator in an independent publication has always been beyond the FDA's control. The FDA concern is that a reader is likely to give more credence to information presented in an apparently objective format than to an obviously paid promotional piece. The FDA holds that most audiences recognize that some degree of "puffery" is inherent in advertisements and paid promotions but that the same degree of skepticism is not present when promotions are made in the settings of medical symposia and journals."

Press and Publicity Activities

The FDA first asserted its jurisdiction over press kits in 1982 In that year, the FDA contended that a press release for a new nonsteroidal anti-inflammatory agent was false and misleading because it tried to establish that the drug acted differently from other drugs in its class, because it gave the impression that the cellular mechanism of the drug was unique and that the drug could potentially suppress bone damage, and because it minimized associated adverse drug effects. The company argued that it had supplied the media with an accurate description of the product and disputed the FDA's findings point by point." An especially important issue was how much the company could be held responsible for the news reports that ultimately appeared in the press. The company recognized that sometimes the reports were misleading but stated that oversimplified or erroneous reports are, to some extent, unavoidable when scientific information is

reported in the lay press. The FDA countered that much of the misleading material resulted from the content of the press kit." The FDA took note that reporters who based stories on the press kit had come to the misleading conclusions.

Clearly, there are some justifications for releasing the results of drug studies to the press before the drug is approved by the FDA. The Securities and Exchange Commission requires that "material" information that can affect the value of a publicly traded company be released to the investment community. In one case, citing the Securities and Exchange Commission requirements, a company distributed a press release after clinical investigators met to discuss the results of their multicenter clinical trial of a drug for the treatment of malepattern baldness. The FDA held that the press release was false and misleading, alleging that it exaggerated the efficacy of the drug through "selective data reporting, and omission of certain efficacy results."" Furthermore, in its response to constitutional questions raised by the company, the FDA recognized that although the drug was unapproved and although discussion of the drug's safety and effectiveness in multicenter clinical trials is traditionally prohibited in promotional activities, prohibiting the press release altogether would raise substantial First Amendment concerns. The agency took the more moderate approach that the materials must simply be more balanced-an approach that most likely would survive constitutional scrutiny." Food and Drug Administration officials privately recognize the need to meet Securities and Exchange Commission disclosure requirements but note skeptically that pharmaceutical companies publicize only positive results, not negative ones.

One of the most interesting cases in the area of press relations involved a physician-investigator who held a press conference to present the results of a randomized, double-blinded study of a drug for the treatment of photo-aging." His results were published the same day in a prestigious medical journal. The drug was already on the market but had not been approved for this use. While the FDA acknowledged that the investigator was free to hold a press conference to discuss new indications not contained in the product's labeling, the agency questioned the appropriateness of having financial support for the press conference provided by the manufacturer of the drug under study.'

Furthermore, this manufacturer also supported a "video news release" that was distributed to television news proRegulation of Drug Promotion-Kessler & Pines

grams. The video began with a lead-in script that could be read by the local news anchor, giving the appearance that the segment was produced locally, and then followed with a report produced by the manufacturer. The "news" report cited the findings published in the then-current issue of the medical journal, including the name of the company's new skin cream and the fact that the drug reversed some of the damage caused by photo-aging." The FDA's concern was that the typical person who saw the piece on the evening news would not recognize that the segment was produced by the drug manufacturer and thus would believe it was objective. Particularly disturbing to the agency was that the product being promoted was already on the market. Had the drug not been available at all, such a news release would have posed less of a public health problem. In this case, there was a marked increase in demand for the drug.

Another public relations strategy has been paying a celebrity to promote a product. Baseball's Mickey Mantle appeared on both network morning news and sports shows to promote a new prescription drug for arthritis, citing the drug's brand name and noting that it had just been approved in the United States by the FDA. The promotion implied that a new "wonder drug" for arthritis had become available. A few days later, the network news show issued a clarification, explaining that the drug was no more effective than any other nonsteroidal anti-inflammatory drug on the market, that this was the first time Mantle had been treated with any drug other than aspirin, and that Mantle was a paid spokesman for the drug company (The Wall Street Journal. February 8, 1990:B6)"

In these cases, the FDA has primary jurisdiction over the product manufacturer. It has no jurisdiction over a journalist. It could exert jurisdiction over a celebrity paid by a company and, therefore, acting as its agent but has not asserted that jurisdiction yet. Direct-to-Consumer Advertising

fuses patients, increases the cost of drugs, puts undue emphasis on pharmacological treatment alternatives, pressures physicians to prescribe products, and results in unnecessary use.' In 1983, after a number of companies began to advertise and others expressed a strong interest in doing so, the FDA requested a voluntary moratorium on direct-toconsumer advertising so that it could explore the issue." In 1985, the agency

lifted its moratorium and said its current rules were sufficient to regulate this area." Presently, the FDA says that consumer advertising is permissible if it meets the regulations for fair balance and includes the brief summary information. 17

Over the last several years, two seemingly contradictory things have happened. First, many in the agency, medical community, Congress, and even the pharmaceutical industry have stated their opposition to the advertising of prescription drugs to consum

era

Second, the use of direct-to-consumer advertising on television and in print has been increasing. To understand how this has happened, it is important to recognize that different forms of direct-to-consumer prescription drug advertising have evolved.

On one end of the spectrum are product-specific consumer advertisements. These advertisements, which promote a specific drug, have generated the most opposition and controversy. The FDA has argued that its regulations are a de facto barrier to product-specific advertisements on network television, since it is extremely difficult to include the brief summary information in a 30-second commercial.

The FDA permits product-specific advertisements to appear on cable television in physician-oriented programs that can also be viewed by other health care workers and by consumers. The FDA requires the brief summary information to appear but permits it to be separated from the advertisements themselves. For example, the Lifetime cable television channel, a health-oriented cable station, runs product-specific prescription advertisements during physician-oriented programs at conventional hours and then scrolls the brief summary information at other times. The FDA also mandates other requirements for such an advertisement: it must refer to the prescribing information in the Physician's Desk Reference, it must display a toll-free telephone number that can be called for prescribing information, and it must be included in a program guide. Each advertisement also has to meet the FDA's fair balance test.

On the other end of the spectrum are disease-specific television advertisements that do not promote a specific product. These "help" or "see your doctor" advertisements have included diseases such as arthritis, hypertension, and hypercholesterolemia. These advertisements are acceptable to the FDA so long as there is no implication that drugs are the only useful treatment and there is not even an oblique reference to a specific product. Nonspecific advertisements will not be undertaken by all drug manufacturers with equal enthusiasm-the use of such advertisements tends to appeal to drug manufacturers who are market leaders in their field."

Occupying the middle ground are advertisements that do not mention a product by name but clearly have promotional objectives for a particular product. For example, in one television advertisement, an elderly man is having trouble walking and wonders whether this is what it "means to get old." An announcer suggests that he may be suffering from intermittent claudication, states that an effective treatment can be prescribed, and suggests consulting a physician. The advertisement did not mention any drug name but did state the name of the manufacturer. The FDA argued that the advertisement was promotional because it emphasized the availability of a drug for treating intermittent claudication. The agency also noted that only one product had FDA approval for use in intermittent claudication-the one manufactured by the sponsor of the advertisement. The FDA and the manufacturer eventually agreed to change the advertisement from "Now there's effective treatment your doctor can prescribe" to "Your doctor can prescribe an effective treatment program." The word program was meant to convey anything from exercise to medication or surgery." While some have suggested that the one-word shift was largely semantic, the agency has stated that advertisements will not be considered promotional so long as they urge patients to see their physician and not necessarily to request a specific medication. Another advertising approach among some manufacturers is to link different types of advertisements. For example, a direct-to-consumer advertising campaign encouraging patients to see their physicians about a specific complaint will be linked with a traditional physician-oriented advertising campaign that encourages physicians to prescribe the manufacturer's product for that complaint.

There is growing interest in direct-toconsumer advertising among television

stations and advertising agencies because of the large potential revenues. The FDA recognizes that it may soon be faced with a problem if the networks devise a mechanism to meet the brief summary requirements (for example, by adopting the approach used by cable television and scrolling the information). A request by a coalition of pharmaceutical manufacturers, networks, and advertising agencies to test several prescription drug advertisements on network television in limited areas, without scrolling the brief summary information, was greeted without enthusiasm by the agency and a congressional oversight subcommittee and was subsequently withdrawn. Similarly, the agency has been confronted with a growing number of consumeroriented, product-specific advertisements in newspapers and magazines that do contain the brief summary information. Meeting the brief summary requirements is more feasible in print than on television.

CONCLUSION

As the field of pharmaceutical advertising and promotion grows, as new communication technologies evolve, and as innovations in marketing appear, the FDA's regulatory framework must be able to meet the challenges of a changing environment.

In developing its policies, the agency must focus on the important public health issues at stake, particularly those that are reasonably within its control. The current regulatory framework is based on subtle and difficult distinetions, such as the difference between "scientific exchange" and "promotion." If a company tells a medical audience about ongoing research but does not suggest that the drug is safe and effective, the communication is regarded as scientific exchange. But if, at the same meeting, the company shows data that suggest that the drug may be useful for a particular indication, the communication might be regarded as promotion. Similarly, if a medical press reporter attends the symposium and writes a story about it, the story might legitimately fall under the banner of scientific exchange. But if television cameramen are invited to be there, then it might be regarded as promotion. In an era when patients have access to the Physician's Desk Reference, when anyone can tune in to the Lifetime cable television channel, when almost every week major scientific studies are reported on the evening news, and when the National Institutes of Health and the FDA themselves sometimes seek to publicize their own research findings, the regulatory

2414

line between scientific exchange and promotion is extremely fine."

Emphasis must be focused on the content of the information being conveyed. The statutory mandate that information not be false or misleading should continue to be the central focus for the agency. Misleading information can result if the sponsorship is hidden, if the drug's status is misidentified, or if the information is inaccurate or taken out of context. Furthermore, in the realm of direct-toconsumer advertising, the determination of whether a commercial falls within the acceptable "see your doctor" category or is actually an advertisement for a prescription drug is sometimes more semantic than substantive. Public health needs should be considered when deciding what kind of advertising is permissible. From a public health perspective, a pneumococcal vaccine aimed at those who are at high risk for the disease is very different from a drug with no unique properties. Ultimately, the risks of overuse and consumer confusion need to be balanced against the benefits that can be achieved by informing the public about the existence of a specific therapy.

The whole notion of the brief summary and fair balance needs to be reexamined. The Lifetime cable channel's scrolling of the brief summary in the early morning hours does little to inform those viewing the advertisement. Some would even argue that a consumer advertisement that includes the brief summary is by definition inappropriate, since the information was written in a form to be used by physicians, not

consumers.

In focusing agency priorities, it is important to recognize that there are times in the drugs product life cycle that should be subject to greatest scrutiny. The launch of a new drug is an especially critical juncture-opinions about the drug are being formed at this time-and, no matter how extensive the previous clinical trials, the adverse event profile of the drug is still incomplete.

Few issues evoke as much debate among physicians, the pharmaceutical industry, and government regulators as the appropriateness and value of pharmaceutical advertising and promotion. Those who question promotional activities need to recognize that they have value, are here to stay, and will continue to be a major source of information about prescription drugs, but those who argue for further expansion of these activities, especially of direct-to-consumer advertising, must exercise caution. If a perception develops that the increase in prescription drug advertising and

promotion is resulting in inaccurate and misleading information, then more aggressive regulation may result."

We are indebted to Kenneth Feather, William Frishman, MD, Mark Hudak, MD. Stephen Keith, MD, Paulette Kessler, JD, Eliot Lazar, MD, Deborah Neipris, JD, Stuart Pape, JD. Louis Schenkel. JD. William Schultz, JD, and Nancy Taylor. JD. for their review of the manuscript; to Karyn Feiden and Rosalyn Kessler for their editorial review; and to Lorraine White for her assistance in preparing the manuscript. We thank the Food and Drug Law Institute for sponsoring several seminars on this subject.

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JAMA, November 14, 1990-Vol 264, No. 18