Health Matrix Clevel
September 2011
This article provides an overview of how the constitutional protections for commercial speech affect the Food and Drug Administration's (FDA) regulation of drugs, and the emerging issues about the scope of these protections. A federal district court has already found that commercial speech allows manufacturers to distribute reprints of medical articles about a new off-label use of a drug as long as it contains disclosures to prevent deception and to inform readers about the lack of FDA review. This paper summarizes the current agency guidance that accepts the manufacturer's distribution of reprints with disclosures.
View Article and Find Full Text PDFSeton Hall Law Rev
April 2008
The process of choosing and prescribing prescription drugs is complex. While the choice about which drug to prescribe is made by the physician, the physician may be influenced by patient demand, which, in turn, may be influenced by consumer advertisements. As a result, consumer advertisements for prescription drugs need to provide information that gives consumers an understanding, not only of drug risks and efficacy but also of the notable limits on benefits claimed.
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