FDA's Drug Ad Rule And Learned Intermediary Doctrine

Law360, New York (July 29, 2010, 2:42 PM EDT) -- On March 29, 2010, the U.S. Food and Drug Administration issued proposed amendments to its regulations concerning direct-to-consumer (DTC) television and radio ads for prescription drugs.

The proposed rule set standards for determining whether DTC ads present warnings in a “clear, conspicuous and neutral manner.” The new standards are highly subjective, and would require interpretation and application to each unique DTC ad. Thus, the new standards could create challenges for pharmaceutical companies in how they develop and approve DTC ads.

Aside from the costs to bring...
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