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

For Release

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.

NOTE: The views expressed in the letter are those of the staff of the FTC’s Bureaus of Consumer Protection and Economics and the Office of Policy Planning, and do not necessarily represent those of the Commission or any individual Commissioner.

Copies of the comment to the FDA are available from the FTC’s Web site at http://www.ftc.gov and also from the FTC’s Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. The FTC works for the consumer to prevent fraudulent, deceptive and unfair business practices in the marketplace and to provide information to help consumers spot, stop and avoid them. To file a complaint, or to get free information on any of 150 consumer topics, call toll-free, 1-877-FTC-HELP (1-877-382-4357), or use the complaint form at http://www.ftc.gov. The FTC enters Internet, telemarketing, identity theft and other fraud-related complaints into Consumer Sentinel, a secure, online database available to hundreds of civil and criminal law enforcement agencies in the U.S. and abroad.

(FTC File No. V040002)

Contact Information

Media Contact:
Mitchell J. Katz,
Office of Public Affairs
202-326-2161
Staff Contact:

Maureen Ohlhausen,
Office of Policy Planning
202-326-2632

Thomas Pahl,
Bureau of Consumer Protection
202-326-2128