Agency Encouraged to Make Disclosure of Risk Information More Consumer-Friendly to Promote Increased Public Understanding
The Federal Trade Commission’s Bureaus of Consumer Protection and Economics, and the Office of Policy Planning staff provided comments this week to the U.S. Food and Drug Administration (FDA) on three recently issued draft guidance documents related to direct-to-consumer (DTC) advertising for prescription drugs and medical devices. The comments said that the proposed guidance documents could represent substantial progress in conveying relevant risk information to consumers about prescription drugs and medical devices in a manner that consumers can understand. The comments, however, also emphasized that research is needed to determine whether consumers and competition would benefit from the proposed disclosure requirements.
The Federal Food, Drug, and Cosmetic Act (FDCA) requires that prescription drug advertising contain a true statement of information in brief summary relating to the side effects, contraindications, and effectiveness of the drug. The FDA recently has been reexamining its regulations regarding DTC promotion of prescription drugs. In early February 2004, the FDA issued two draft guidance documents on DTC ads for prescription drugs – one on the brief summary requirement for DTC print ads for prescription drugs and the other on help-seeking ads for prescription drugs. At the same time, the FDA issued a draft guidance document on the brief summary requirement for DTC broadcast ads for restricted medical devices, that is, devices for which a prescription is required, such as pacemakers, corrective contact lenses, and hearing aids.
The FDA subsequently sought comment on the three draft guidance documents. The FDA’s overall goal was to encourage a more consumer-friendly presentation of the potential risks of these pharmaceuticals and devices.
The FTC Staff’s Comments
According to the FTC staff’s comments:
- The FDA’s proposed new options to meet the brief summary requirement for DTC print ads for prescription drugs might be an improvement over the current brief summary requirement. The FDA, however, should conduct consumer research to determine whether these proposed options, or other formats, are the most effective means of providing risk information in DTC print ads for prescription drugs.
- The FTC staff agrees with the FDA’s suggestion that the FTC has jurisdiction over help-seeking ads regarding prescription drugs pursuant to Section 5 of the FTC Act.
- The FDA’s proposal to extend the same brief summary requirement for DTC broadcast advertisements for prescription drugs to DTC broadcast advertisements for restricted medical devices is likely to lead to increased advertising for restricted medical devices, thereby benefitting consumers and competition.
In concluding its comments, the FTC staff wrote, “In light of the important role that DTC advertising can play in keeping consumers better-informed about their healthcare and treatment options, [we] support the FDA’s effort to improve the facilitation of truthful, non-misleading information in DTC advertising.”
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 comment 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. V040016)
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