Staff Members of FTC have Recommended some Alternative, and more Flexible, Strategies for the Food and Drug Administration to Consider in Regulating Economic Claims Made in Marketing Prescription Drugs to Health Plans and Other Business Entities.

For Your Information

Staff members of the Federal Trade Commission have recommended some alternative, and more flexible, strategies for the Food and Drug Administration to consider in regulating economic claims made in marketing prescription drugs to health plans and other business entities. More and more claims about the cost-effectiveness of drugs are being used in marketing pharmaceuticals to health plans, according to the FDA, which sought public comments on proposals governing their use.

The FTC staff suggested that the FDA consider a more flexible substantiation standard that requires competent and reliable evidence, the level of which depends on the claim being made, rather than an a priori requirement as to the specific type of evidence required. The FTC staff also suggested that the FDA may wish to consider a disclosure approach for any deception concerning "switch" programs. These are programs in which managed care plan pharmacists seek physician approval to switch a patient from a prescribed drug to a preferred drug that is manufactured by a drug producer affiliated with the pharmacist. Clear and conspicuous disclosure could cure any deception that might occur, while preserving the economic benefits of the programs, the FTC staff said.

These comments represent the views of staff members of the FTC's Bureaus of Economics and Consumer Protection and not necessarily the views of the Commission or any individual Commissioner. Copies of the comments are available from the FTC's Public Reference Branch, Room 130, 6th Street and Pennsylvania Avenue, N.W., Washington, D.C. 20580: 202-326-2222; TTY for the hearing impaired 1-866-653-4261. To find out the latest news as it happens, call the FTC's NewsPhone at 202-326-2710. FTC news releases and other documents also are available on the Internet at the FTC's World Wide Web Site at http://www.ftc.gov

 

(FTC Matter No. V960002)