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GAO examines FDA oversight of promotion of drugs for off label uses

July 2008, US GAO published, 'Prescription Drugs FDA’s Oversight of the Promotion of Drugs for Off-Label Uses', a Report to the Honorable Charles E. Grassley, Ranking Member on Finance , US Senate. (29 pp + appendices)

Drug companies provide medical professionals and consumers with information about prescription drugs in a variety of ways such as direct to consumer advertising on TV or the Internet, presentations by drug companies sales representatives and patient brochures provided in doctors’ offices. Although drug companies are permitted to promote their drugs, these promotions may not be false or misleading and must comply with applicable laws and regulations. FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) has responsibility for overseeing materials an d activities that promote prescription drugs and identifying potential violations.

FDA prohibits drug companies from promoting drugs for off-label uses, that is, for a condition or patient population for which the drug has not been approved or in a manner that is inconsistent with info found on the approved drug label. Although doctors may prescribe drugs off label it is not permissible for drug companies to drugs for off-label uses. Concerns about the off-label use of drugs and associated promotions have mounted in recent years, instances of patients being improperly medicated and consequently injured have been reported back. This GAO examination was limited to FDA’s oversight of human drugs, they did not examine FDA’s oversight for promotion of other types of products under FDA’s jurisdiction.

GAO reported its findings, included the following:
FDA oversees drug promotion for off label use by reviewing promotional materials that drug companies submit to the agency. Its oversight occurs within the broader process that targets a variety of promotional violations. FDA reports that it is unable to review all submissions due to volume and does not prioritize review but relies on staff to sort through the volume of submissions and to select submissions for review...In 2006 GAO recommended that FDA track which materials it reviews. GAO also stated that FDA lacks a standardized tracking system to monitor its review efforts...FDA raised concerns with GAO’s assessment that FDA does not systematically prioritize all of the promotional materials it receives. FDA also stated that a tracking system would not improve the agencies ability to identify promotional violations. GAO also found the FDA does not screen all promotional materials.
FDA/ DOJ have taken regulatory and enforcement actions against drug companies in response to off-label promotions. During calendar years 2003-2007 , FDA issued 42 regulatory letters in response to off-label promotions requesting drug companies to stop dissemination of violative promotions. FDA took an average of 7 months to issue these letters from the time it first drafted them.... While FDA did not refer any of the violations to the DOJ for enforcement action during this period, DOJ settled both civil and criminal cases that involved at least in part off label promotions. These actions were initiated as a result of violations identified by sources other than FDA and resulted in 11 settlements.


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