Direct-to-Consumer Drug Ads

Background: The US Food and Drug Administration (FDA) asked for public comment regarding the direct-to-consumer (DTC) advertising of prescription drugs. In response to the FDA request, the Federal Trade Commission (FTC), not exactly the "public," released their response summarizing their opinion of the economic impact of DTC advertising as well as a number of suggestions for improving DTC ads.

FTC Statement: The FTC concludes that "...DTC advertising generally benefits consumers..." by providing "useful information about the drug options open to them." The FTC also feels that DTC advertising "empowers consumers to interact with physicians more effectively" and that DTC advertising does not increase the sale of inappropriate drugs or lead to increased drug prices. A major suggestion was that the FDA modify broadcasts and print ad requirements so that consumers can more accurately grasp a particular drug's risks and benefits.

Our Comments: We would like to have more information as to how the FTC concluded that DTC ads do not increase the inappropriate sale of drugs or lead to increased drug prices. Ultimately, it should be a medical determination as to whether a particular prescription drug is appropriate for a patient. And someone ends up paying for all those expensive drug ads on prime-time television.

Barbara K. Hecht, Ph.D.
Frederick Hecht, M.D.
Medical Editors, MedicineNet.com


FTC Staff Provides FDA with Comments on Direct-To-Consumer Prescription Drug Advertising

Agency Encouraged to Examine Ways to Provide Consumers with Truthful, Non-Misleading Information in a Format That is Easy to Understand and Access

In response to a request for public comment by the U.S. Food and Drug Administration (FDA), the staff of the Federal Trade Commission filed a comment on December 1, 2003 regarding direct-to-consumer (DTC) advertising of prescription pharmaceuticals. The staff's response analyzes the overall economic effects of such advertising and provides the FDA with a number of suggestions about how its regulatory scheme for DTC advertising could be modified to communicate information to consumers in an easy to understand and accessible way.

According to the staff's comment, which can be found as a link to this press release on the FTC's Web site, "Empirical evidence suggests that the FDA's current approach to regulating DTC advertising generally benefits consumers." Survey evidence suggests, according to the staff, that "DTC ads have provided consumers with useful information about the drug options open to them," and this has "empowered consumers to interact with physicians more effectively." The comment further states that the available evidence does not support concerns that DTC advertising has increased the sale of inappropriate drugs or led to increased drug prices.

Analysis of DTC Advertising Regulations

The staff comment also makes the following suggestions regarding how the FDA's DTC advertising regulatory scheme could be modified to communicate truthful, non-misleading information in a way that is easier for consumers to understand and use:

  • The brief summary requirement for broadcast ads- a major statement of drug risks along with adequate provision for more complete risk information - should be retained, but modified.

  • The brief summary requirement for broadcast ads should be modified so that consumers would be directed to a more useful source of risk information than the labeling the FDA approved for the product as part of its drug approval process, such as FDA-approved patient labeling or other risk information that has been specifically designed for consumers.

  • The brief summary requirement for print ads - that complete risk information (such as the labeling that the FDA approved for the product as part of its drug approval process) be included in the ad - should be made consistent with the brief summary requirement for broadcast ads.

  • The fair balance requirement for DTC ads should prohibit only ads that convey a deceptive impression of the risk and benefits from the overall presentation of information, rather than those that fail to achieve a mechanistic balance between risk and benefit information.

  • Pharmaceutical manufacturers should be permitted to make truthful, non-misleading price comparisons and other types of relative cost claims.

  • The FDA should apply the same standards for endorsements and testimonials in DTC ads for prescription drugs as the FTC applies through its Guides Concerning the Use of Endorsements and Testimonials in Advertising to endorsements and testimonials for other products, including over-the-counter (OTC) drugs.

  • Internet advertising should be treated consistently with DTC ads in other media, and it would be beneficial if the FDA were to issue a guidance document addressing DTC ads available on the Internet.

In concluding its comment, the FTC staff writes, "DTC advertising can play an important role in providing information about prescription drugs that may spur consumers to seek help for a previously untreated condition, encourage them to talk with a doctor about a new drug, or otherwise take a more proactive role in minding their health. We therefore encourage the FDA to examine ways to facilitate the flow of truthful, non-misleading information in DTC advertising in a manner that is easy for consumers to understand and access."

The Commission vote authorizing staff to issue the comment in response to the FDA's request was 5-0.

Source: Federal Trade Commission Press Release, December 2, 2003 (www.ftc.gov)


Last Editorial Review: 12/4/2003