Medicare Compliance & Reimbursement

PHARMACEUTICALS:

Legislators Sound FDA Intervention Call On Drug Ads

Officials: DTC tactics are dangerous and misleading.

As more revealing data become available on pharmaceutical companies' direct-to-consumer advertising and its effects on prescribing trends, panelists from influential organizations have shed some light on the real impact of DTC ads--and why the Food and Drug Administration hasn't stepped in yet.

At the Sept. 29 Senate Special Committee on Aging hearing concerning DTC drug advertising's impact on seniors' health and health care costs, committee chairman Sen. Gordon Smith (R-OR) asked panelists to address research suggesting that advertising encourages individuals to learn more about symptoms of and treatment for undiagnosed conditions. He also asked the panelists to weigh whether DTC advertisements' content appropriately informs individuals of new prescription drugs' benefits and risks, and whether the ads are aimed more at building product loyalty.

Noting that DTC advertising has quadrupled since 1998, Gordon pressed for further exploration of prescribing behavior--especially in connection with how it affects consumer safety and overall prescription drug consumption. From a positive standpoint, DTC advertising may encourage people who might otherwise not seek health care to see their doctors, particularly in cases of individuals suffering from a mental illness, such as depression or bipolar disorder, he said.

Gordon cited a 2003 study showing that approximately 25 percent of surveyed individuals who had discussed an advertised drug with their physicians reported receiving a new diagnosis. The Senate committee is also concerned with other types of promotional activities, especially those targeted toward physicians and their office staff.

Rachel E. Behrman, the Office of Medical Policy Center for Drug Evaluation and Research's deputy director and the FDA's director for its Cross-Centers Initiatives Task Force Office of the Commissioner, reviewed how the FDA regulates DTC advertising and the results of recent surveys the agency had undertaken to ascertain consumers and physicians' attitudes toward marketing activities.

Surveys showed DTC ads can encourage consumers to seek information about an illness, condition or a drug from their physician or pharmacist, Behrman reported.
 
But research also demonstrated that patients and physicians believe DTC ads frequently overstated drugs' benefits and understated the risks.
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