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Drug advertising and accountability.

Article Excerpt
At a time when pills are touted on TV and the Internet, the doctor's traditional role as a learned intermediary has been undermined. Pharmaceutical manufacturers should be held accountable for failing to warn consumers directly of the dangers posed by their products.

Anyone with a TV has seen the commercials: A former presidential-candidate-turned-spokesman for an erectile dysfunction drug, a gold-medalist skater touting a prescription pain medication, and the once-ubiquitous advertisements urging us to ask our doctor about a drug without revealing the condition it is supposed to treat.

Whether on television, radio, magazines, or billboards, pharmaceutical advertisements are unavoidable. The pharmaceutical industry spent an unprecedented $2.6 billion in direct-to-consumer (DTC) advertising in 2001. (1) This represents a spending increase of more than $200 million over the previous year. (2) Promotional spending directed at consumers increased by 212 percent between 1996 and 2000. (3)

DTC advertising of prescription drugs has been a source of controversy since it began in the early 1980s. The FDA announced a voluntary moratorium on the practice in 1982, perhaps prompted by concerns about an onslaught of advertisements for risky products consumers could not legally obtain without a prescription. (4) The agency said it needed time to study the issue before deciding whether such advertisements were proper.

In 1985, the FDA decided to allow DTC advertising. (5) DTC ads were required to meet the same disclosure requirements for risks and benefits as those directed at physicians. However, broadcast advertisements were exempted, as long as they contained a "major statement" of the risks and made "adequate provision" for consumers to obtain complete prescribing information. (6) Yet the FDA regulations did not define either requirement. The industry's uncertainty about what constituted "adequate provision" slowed the growth of broadcast DTC advertising, at least temporarily.

In response to industry concerns, the FDA released draft guidelines in 1997--finalized without substantial change in 1999--illustrating one approach to compliance. Under this approach, if broadcast material met the FDA's criteria for being "fair-balanced" and disclosed the most important risks, then "adequate provision" would be satisfied if the ad included each of the following: a toll free number through which complete prescribing information could be obtained, a reference to a print advertisement containing that information, disclosure of a Web page containing product information, and a referral to a health care provider. (7)

Arguably, the FDA's 1985 decision and the guidelines created a system in which consumers are exposed to diluted images of a product's true risks. By not requiring disclosure of all risks in advertisements, the system relies on the consumer to take the initiative to seek complete information. Having resolved the question of how "adequate provision" can be made, the agency set the stage for DTC advertising's rapid growth.

The prevalence of pharmaceutical advertising obscures the reason why these drugs are not available without a prescription. Indeed, as the New Jersey Supreme Court, quoting the Harvard Law Review, recognized in the landmark Perez v. Wyeth Laboratories, Inc.:

"Research indicates that general warnings (for example, see your doctor) in [direct-to-consumer] advertisements do not give the consumer a sufficient understanding of the risks inherent in product use." Consumers often interpret such warnings as a "general reassurance" that their condition tan be treated, rather than as a requirement that "specific vigilance is needed to protect them from product risks." (8)

Trial lawyers, on the other hand, know...

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