CHICAGO -- The American Medical Association urged the government yesterday to force pharmaceutical companies to delay advertising new prescription drugs directly to consumers until physicians have time to review and study their safety and effectiveness.
The largest U.S. doctor group wants the U.S. Food and Drug Administration to impose rules that would require an unspecified amount of time between a drug's approval and the start of a comsumer ad campaign, particularly commercials on television.
"A temporary moratorium on direct-to-consumer advertising of prescribed drugs and medical devices will benefit both the patient and physician," said AMA President-elect Dr. Ronald Davis, a preventive medicine specialist from Michigan. "It's possible that companies could do it voluntarily with some coordination or oversight of their trade association, but failing that, the government could step in to put that policy in effect."
The FDA does not require a moratorium, but there has been interest by some Republican and Democratic federal lawmakers for such a measure although no bills have been moving through Congress of late. The decision to back a moratorium, made by the AMA's policymaking House of Delegates on the last day of its five-day annual meeting here, puts the organization's political influence behind federal regulations that could rekindle congressional action.
For its part, the FDA would not say whether it favored a temporary moratorium but said it closely monitors direct-to-consumer "promotional material," FDA spokeswoman Susan Bro said. "When we have concerns, we take action and industry has been very responsive to the FDA's concerns."
Such increased scrutiny of drug ads comes in the wake of product safety issues involving heavily promoted drugs such as Vioxx, a painkiller that was pulled from the market nearly two years ago after studies showed it increased risks of heart attacks and strokes.
Doctors also say the ads get in the way of the doctor-patient relationship while also contributing to rising health care costs because the drugs advertised are usually the latest, most-expensive brand-name drugs. Drug ad spending has quadrupled to more than $4 billion since 1998, the first full year after the FDA eased restrictions.
AMA delegates testified throughout this past week's meeting that they become frustrated when patients visit their offices and ask about drugs that the doctors know nothing about or have not had time to evaluate through medical journals or scientific studies. Doctors also take issue with other messages that they say mislead patients, such as the use of actors playing doctors in ads.
"We object to the use of physician likenesses," said Dr. Bobby Mukkamala, an AMA delegate and ear, nose and throat specialist from Flint, Mich. "To use actors is misleading."
In particular, AMA delegates complained about Merck & Co.'s ad for the cholesterol drug Zetia, which uses physician actors. But Merck spokeswoman Amy Rose said the ad "clearly identifies the participants as actors so as not to mislead anyone."
More broadly, the drug industry trade group and lobbying organization, Pharmaceutical Research and Manufacturers of America (PhRMA), says pharmaceutical companies have improved their ads in the wake of criticism but have offered voluntary solutions.
Under current federal regulations, companies submit their consumer ads to the FDA "at the time of first use," said PhrMA senior vice president Ken Johnson. He said the industry's voluntary guidelines encourage companies to submit new consumer ads to the FDA "a reasonable time in advance of release."
The drug industry trade group does not support a government moratorium. "We have some concern that a requirement for mandatory prior FDA approval of all (direct-to-consumer) advertising might have the unintended consequence of unnecessarily delaying when patients hear of a new treatment," Johnson said.
Bruce Japsen writes for the Chicago Tribune.