DTC ads criticized by Congress, AMA

WASHINGTON Direct-to-consumer ads took another hit yesterday when lawmakers and the American Medical Association said that they should be limited and/or monitored in an effort to control deceptive marketing from reaching consumers, according to published reports.

A moratorium should be placed on ads for newly approved drugs until doctors are educated and regulators have signed off on the messages, the medical association, said yesterday at a House subcommittee hearing on drug advertising. Representative Bart Stupak said Congress should consider new restrictions on ads.

“Congress needs to decide whether the US should continue to be one of two countries in the world that allow DTC ads, and if we continue to allow such advertising, whether any further limits to DTC ads should be required,” said Stupak, D-Mich., head of the Energy and Commerce Subcommittee on oversight and investigations. “It appears that we need to enforce significant restrictions on DTC ads.”

Drug makers spent $5.4 billion last year on DTC advertising, according to market research firm Nielsen Monitor-Plus. That’s a fivefold increase in the decade since rules about the disclosures required in television ads were changed, allowing drug makers to more easily air commercials. Lawmakers said the ads gloss over risks and may cause overprescribing of expensive medicines.

Companies that were targeted at the meeting was Merck and Schering-Plough for marketing of their cholesterol drug Vytorin, Pfizer for using a doctor, who does not practice medicine in their ads for their cholesterol drug Lipitor and the anemia drug Procrit by Johnson & Johnson.

Pfizer senior director James Sage defended his company’s role in using Dr. Robert Jarvik, who isn’t a practicing physician but who helped design the artificial heart, in its TV ads for Lipitor.

“Although not a practicing physician, he has devoted his entire career to medical science related to the human heart,” Sage said. “An important objective of the Jarvik advertising campaign for Lipitor was to highlight the importance of diet and exercise in reducing cardiovascular risk.”

Sage, and officials from the other companies, all said they submitted the ads, after they began running, to the Food and Drug Administration for comments. Sage said the company made several changes to its ads for Lipitor, including weakening claims about its ability to lower cholesterol as compared to other drugs.

FDA officials were not invited to participate.