FTC Staff Comments on FDAs Plans to Collect Information on Direct-To-Consumer Prescription Drug Advertising

Staff of the Federal Trade Commission’s Bureau of Economics, Bureau of Consumer Protection, and Office of Policy Planning support a proposal by the U.S. Food and Drug Administration to survey patients and physicians to assess the impact of direct-to-consumer (DTC) prescription drug advertising. In comments on FDA’s proposal submitted to the U.S. Office of Management and Budget (OMB), FTC staff said that such data "are critical to improve our understanding of the role of advertising, and advertising regulation, on consumer welfare."

FDA was required to submit its survey proposal to OMB for review and clearance under the Paperwork Reduction Act of 1995, and OMB requested comments on the FDA’s proposal.

The surveys ask questions designed to elicit information about the extent of potential benefits and harm presented in DTC advertising. In its comment, FTC staff suggested additional questions addressing insurance and costs that FDA may wish to include in its two surveys. For example, in the consumer survey, information on the role of drug costs may help analysts estimate the extent to which DTC advertising may lead to lower prescription drug prices. In addition, to ascertain whether DTC advertising has different effects depending on whether a patient has prescription drug coverage, FTC staff suggested that FDA ask patients whether they have such coverage through their health insurance or HMO.

FTC staff suggested also that if policymakers wish to assess whether the effects of DTC advertising are perceived differently by different types of specialists, then the FDA should consider the benefits and costs of increasing the number of physicians surveyed. In addition, FTC staff suggested that FDA staff may wish to create a control group of physicians in a specialty that encounters very little DTC advertising.

The Commission vote authorizing the staff to submit its comment to OMB was 5-0. These comments represent the views of the staff of the FTC’s Bureau of Economics, Bureau of Consumer Protection, and Office of Policy Planning. They do not necessarily represent the views of the Commission or any individual Commissioner.

Copies of the staff’s comment 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.: V010008)