Magazine article FDA Consumer

Study Funds Rx Drug Ads Misleading

Magazine article FDA Consumer

Study Funds Rx Drug Ads Misleading

Article excerpt

A remarkably high proportion of prescription drug advertising from June 1990 contains misleading information and appears to violate FDA regulations, according to a study conducted by the UCLA School of Medicine.

Under the auspices of the HHS Office of the Inspector General, FDA examined the ads and is seeing that the misleading ads are corrected.

The study was reported June 1 in the Annals of Internal Medicine, which also contained an editorial on the subject by FDA Commissioner David A. Kessler, M.D. The researchers found that 40 percent of the ads did not contain the required risk/benefit information and 44 percent would lead to improper prescribing if physicians used only the information in the ads. Moreover, the researchers concluded that many ads are deficient in areas for which FDA has explicit standards and that new strategies are needed to ensure that ads follow existing rules and protect consumers.

The study reflects the situation in 1990 before FDA's increased prescription drug advertising review and the pharmaceutical industry's recent increased cooperation. Kessler stated that its publication is important because it heightens awareness of the degree to which misleading information may pervade the "informational marketplace" underlying physicians' prescribing decisions.

The study's findings were consistent with FDA's assessment of the advertising marketplace in 1990, after which FDA's division of drag marketing, advertising and communications and the division of biometrics started determining what kinds of clinical-statistical problems existed with research cited by manufacturers' support to their ad claims. …

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