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Harvard Doctor Warns Against Loosening Restrictions for Off-Label Marketing

Jul 1, 2015

The U.S. Food and Drug Administration (FDA) is holding a meeting to discuss its restrictions on off-label marketing, which is when drug companies promote their drugs for uses not approved by the agency. The meeting will discuss whether or not these restrictions impede on the liberty of these manufacturers. Recently, a Harvard professor and physician warned that loosening these restrictions would be detrimental to public health and safety.

Under current regulations, drug companies are not allowed to market their drugs for unapproved uses but physicians can prescribe drugs off-label as they see fit. On June 30, 2015, the Annals of Internal Medicine published an opinion piece by Jerry Avorn, MD, a Harvard professor and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital.

Dr. Avorn warns that if restrictions are eased for off-label marketing, it would be a backwards step. He cites the thalidomide tragedy, which prompted the need for efficacy data in the 1960s, and indicates that the FDA would be heading towards an era prior to this period if regulations are loosened. Avorn writes "The proposals under discussion fly in the face of much of what we know about rigorously evaluating clinical interventions. First, they would allow companies to short-circuit the need for a review of the totality of the available data (including those secret proprietary files), and permit them to present clinicians with cherry-picked studies that may look good in isolation but could be methodologically inadequate, or fail to present a balanced picture of a drug's benefits and risks. A second problem is the unreliability of "clinical experience" measures such as "observational studies, registries, and therapeutic use" as well as guidelines to assess efficacy, as is advocated in pending legislation."

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