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05/13/2014: "FDA: Allowing Big Pharma's Off Label Advertising"


Filed under: Announcements,Ethics,Healthcare,Pharmacology,psychiatrist,psychiatry,Rx Meds
Tags: FDA, food and drug administration, off-label, Pharmaceutical

According to the Indianapolis Star this morning, the Food and Drug Administration will continue allowing pharmaceutical companies efforts to market a drug's "off-label" uses, as long as the companies adhere to certain guidelines. This "marketing" includes giving physicians articles describing "off-label" use. In the past this practice has come under fire as the companies themselves sponsored the research and the articles were not published in peer reviewed journals. According to the new guidelines;

Articles should not be false or misleading and should come from a peer-reviewed journal that is not influenced by the company. The proposal also says companies should attach a disclaimer to the materials indicating that the FDA has not reviewed them.

Drug industry advocates said the proposal firmly establishes FDA's role as a regulator of medicine--" not information.

However, these "advocates" have a lot to gain by the ruling.

Off-label prescriptions account for an estimated 21 percent of overall drug use, according to a 2006 analysis in the Annals of Internal Medicine. The practice is common in treating conditions such as cancer, where doctors will prescribe drugs approved for one type of cancer for another.

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