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November 1, 2000

Challenges in Regulating Direct-to-Consumer Advertising

Author Affiliations

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JAMA. 2000;284(17):2242. doi:10.1001/jama.284.17.2242-JMS1101-3-1

For the Food and Drug Administration (FDA), there has always been 1 central question surrounding direct-to-consumer (DTC) advertisements of prescription medications: Do these advertisements provide consumers with information that empowers them to care for their health, or are they misleading in a way that presents a public health hazard?

To ensure that advertisements for medications provide public health benefits without creating health risks, the FDA determined more than 30 years ago that under the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act, advertisements must have 4 basic attributes: (1) they cannot be false or misleading; (2) they must present a "fair balance" of information about the risks and benefits of using the drug; (3) they must contain "facts" that are "material" to the product's advertised uses; and (4) in general, the advertisement's "brief summary" of the drug must include every risk from the product's approved labeling.1

For many years, pharmaceutical promotion was directed exclusively at health care professionals. After the first DTC prescription drug advertisements appeared in the early 1980s, however, researchers began to question whether pharmaceutical advertisements could "serve two masters: the promotional interest of the pharmaceutical industry and the public's health needs."2 In response to calls from both the public and manufacturers, the FDA requested that companies suspend their DTC promotion while it conducted a study of its effect on consumers.3

The results of the study satisfied most FDA concerns about the new wave of DTC promotion. Among other insights, the study showed that such advertisements can successfully communicate a large amount of information about the potential risks of taking prescription medications. Sixty-six percent of the 1500 survey respondents regarded DTC promotion as useful, and 74% of them strongly supported their physician as the decision-maker in the prescription of drugs. Based on these findings and consultations with consumers, the FDA lifted the DTC moratorium in 1985 and announced that the existing regulations were "sufficient . . . to protect consumers."4

Promotion of prescription medications by television and radio—media with severe time constraints—has presented a special regulatory challenge. For many years, pharmaceutical companies avoided the requirement for lengthy risk disclosure by airing vague "reminder" messages. Critics charged, however, that the commercial spots were often confusing and provided little information that consumers could use to improve their health care.5

By the mid-1990s, public input and the FDA's own experience with DTC promotion prompted the agency to publish a draft guidance designed to encourage more informative commercials. The document stated that broadcast commercials could meet FDA requirements for risk disclosure if they list the product's major risks and provide the audience with instructions for obtaining the full product labeling.6 The guidance, which was finalized last year, also announced that the FDA would assess its impact and that of DTC promotion in general, a process that is still under way.

Although pharmaceutical companies are not required to submit the content of their DTC promotional materials to the FDA for prior clearance, the agency routinely examines commercials and published DTC drug ads after they become available to the public. In the last 3 years, the FDA has sent about 70 notices to sponsors that their promotion violated regulations, usually by presenting insufficient or understated risk information, and in some cases by overstating the product's effectiveness or the extent of its approved use. Companies have historically complied with the FDA's requests, and the number of broadcast violations has declined.

A consumer survey conducted by the FDA in 1999 suggested that DTC prescription drug promotion offers public health benefits that may outweigh the potential costs.7 For example, patients report that DTC advertisements remind them to get their medicines refilled and help them adhere to their regimens; advertisements also prompt patients to ask their physicians about new medical conditions.

But while 62% of respondents said that DTC advertisements helped them discuss their health with physicians, not all the responses were favorable. Fifty-eight percent said that the advertisements "make the drugs seem better than they are." Other research suggests that DTC promotion causes tension between patients and their physicians, and that physicians are less positive about DTC ads than most consumers.8 There are also questions as to whether the multiple-page long lists of risks required for printed advertisements—which may be ignored by 33% of patients—are optimal.

After more research, the FDA will carefully evaluate DTC drug promotion and take any additional measures needed to protect the public's health.

Not Available, Kefauver-Harris Act 21. Code of Regulations. 2.2.1 (1962).
Bradley  LRZito  JM Direct-to-consumer prescription drug advertising.  Med Care. 1997;3586- 92Article
Food and Drug Administration, Prescription Drug Advertising to Consumers: Brief Summary Formats for Television and Magazine Advertisements.  Rockville, Md National Press Office1984;
Not Available, Not Available  50 Federal Register 36677 (1999).
Food and Drug Administration, Draft Guidance to Industry: Consumer-Directed Broadcast Advertisements.  Rockville, Md National Press Office1997;
Not Available, Not Available  64 Federal Register 43197 (1999).
Not Available, Attitudes and behaviors associated with direct-to-consumer (DTC) promotion of prescription drugs: preliminary survey results. Food and Drug Administration Web site. Available at: http://www.fda.gov/cder/ddmac/research.htm. Accessed September 15, 2000.
Wiles  MSBell  RAKravitz  RL Direct-to-consumer prescription drug advertising: trends, impact, and implications.  Health Aff (Millwood). 2000;10110- 128Article