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AMA: Doctors Demand Hold on Consumer Ads on New Drugs Until Physicians Get Briefed

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CHICAGO - The American Medical Associations wants the FDA to make industry hold off on direct-to-consumer ads for new agents or implantable devices until physicians are brought up to speed.

CHICAGO, June 15 - The American Medical Association wants physicians to be given a head start on patients on the details about new drugs and implantable devices.

The AMA will ask the FDA to block direct-to-consumer ads for newly approved drugs and implantable medical devices until physicians have had time to be brought up to speed on the indications and "innovative nature" of the new therapeutics.

As orthopedic surgeon Ralph DiLibero, M.D., of Palos Verdes Estates, Calif., put it, "we don't want anything advertised to our patients that hasn't gone through physicians first."

The AMA's request for a moratorium on advertising of new drugs was part of a package of public health measures approved by the AMA's House of Delegates during its annual meeting here.

A second measure put the FDA and White House on notice that the AMA is fed up with the mixing of politics and science at the FDA.

The AMA said the FDA "should not permit political considerations to overrule scientific evidence in making policy decisions." Asked whether this was aimed at the FDA's delay in approving the over-the-counter status for the emergency contraceptive called Plan B, despite the unanimous recommendations of an FDA advisory committee, AMA president-elect Ronald Davis said the association supports OTC sales of Plan B.

"The [Plan B] decision has been delayed long enough," he said.

Dr. Davis, a preventive medicine specialist from East Lansing, Mich., said the latest AMA policy on DTC advertising of prescription drugs updates AMA advertising guidelines drafted with the FDA in 1993.

In addition to demanding a moratorium on new drug advertising, the AMA said that pharmaceutical companies should not hire actors to play the role of doctors or other health professionals in television ads for drugs. And the AMA also took umbrage at real physicians as product spokespersons.

Physicians, the AMA said, should be discouraged from direct product endorsements, but if a physician appears in an ad "there should be a prominent disclaimer noting that the physician was paid to endorse the drug or device," the AMA said.

The AMA also said it opposed "any manufacturer (drug or device sponsor) incentive programs for physician prescribing and pharmacist dispensing that are run concurrently with [direct to consumer] advertisements."

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