The Federal Trade Commission wants comments from the pharmaceutical industry about its guidelines governing paid product endorsements, Division of Advertising Practices Assistant Director Thomas Pahl told a Food & Drug Law Institute conference Sept. 12 in Washington, D.C.

"I think that it would be very useful for the agency if some of you would provide us with further information as to whether those guides should be retained or we should change them in some way," Pahl said.

FTC updates its advertising guidances every 10 years. Pahl noted that the current endorsement guides were written before FDA changed its policies on direct-to-consumer broadcast ads in 1997.

FTC plans to publish a notice announcing the update process this fall.

The "guides predate the tremendous growth in DTC advertising," Pahl noted. "They go back to when there was very little direct-to-consumer advertising for drugs at all."

The pharmaceutical industry is used to working with FDA on regulation of prescription drug ads, but FTC also has enforcement jurisdiction.

Pahl highlighted two issues in the current endorsement guides that industry may want to comment on: (1) disclosure of funding for research; and (2) product claims made by celebrities.

The current FTC ¹ guidelines allow companies to present independent research findings without disclosing the source of funding.

In a case where "a drug company commissions research on its product by a well-known research organization" and "pays a substantial share of the expenses of the research project," the funding does not need to be disclosed as long as "the test design is under control of the research organization," the advertising guide states.

The guidelines note that such an ad must still follow standards for endorsements by organizations and experts.

"I think we'd be interested in" hearing "what consumer perceptions on that issue is, and get some idea of what actual practice is as to representations about research findings as they're out there," Pahl said.

In addition, "the guides currently prohibit celebrity endorsers from making efficacy claims in drugs, unless the...drug company can substantiate the claims made."

"This provision predates most of the drugs in DTC advertising," Pahl noted, "so we would be interested in...thoughts that drug companies would like to submit as to whether that provision still makes sense."

Celebrity endorsements have been a feature of pharmaceutical promotions dating back at least two decades.

FDA has weighed in over the years on issues ranging from Mickey Mantle's endorsement of Ciba's (now Novartis) Voltaren and Cal Ripken's appearance in a journal ad for Merck's Prinivil (² Also see "MERCK PRINIVIL RIPKEN ADS NEED STRONGER DISCLAIMER, FDA TELLS COMPANY; GEMZAR PROMOTIONS, CLARITIN 1-800 LINE, ULTANE JOURNAL ADS RUN AFOUL OF FDA" - Pink Sheet, 31 March, 1997., p. 11).

However, the appearance of celebrities in television commercials about prescription drugs is a more recent phenomenon.

Bayer/GSK hired former Chicago Bears Coach Mike Ditka to serve as a spokesman for "Tackling Men's Health," which is intended to raise awareness of men's health issues and the companies' erectile dysfunction treatment Levitra (vardenafil) (³ 'The Pink Sheet' Aug. 25, 2003, p. 3).

Pfizer's DTC ads for its competing product, Viagra (sildenafil), feature Texas Rangers baseball player Rafael Palmeiro. The company has previously run television commercials featuring former Senate Majority Leader Bob Dole (R-Kan.) and NASCAR driver Mark Martin.

There has also been recent media attention to cases where celebrities have appeared on news or entertainment programs to talk about medical issues without disclosing a sponsor relationship.

FTC Updating Product Endorsement Rules; Asks Rx Industry To Comment

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