Prescription Drugs: FDA's Oversight of the Promotion of Drugs for Off-Label Uses
DIANE Publishing, 2008 - 41 pages
The FDA regulates the promotion of prescription drugs (PD) to ensure that promotional materials are not false and misleading and that they comply with applicable laws and regulations. FDA prohibits drug co. from promoting PD for off-label uses -- that is, for a condition or patient population for which the PD has not been approved or in a manner that is inconsistent with info. found on the approved PD label. Although doctors may prescribe PD off label, it is not permissible for drug co. to promote PD for off-label uses. FDA may take regulatory actions for violations. This report provides info. about the promotion of PD for off-label uses. It reviewed: how FDA oversees the promotion of off-label uses of PD; and what actions have been taken to address off-label PD.
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11 settlements 42 regulatory letters accelerated approval process According to DDMAC Actelion Pharmaceuticals advisory review agency’s analysis of FDA Appendix bipolar disorder Bristol-Myers Squibb Company calendar years 2003 cancer Ciloxan citing off-label promotion Climara company’s DDMAC officials told DDMAC staff Diovan disorder drug for off-label DTC advertisement Effexor enforcement action example FDA issued FDA Regulatory Letters FDA’s oversight final promotional materials Flonase Gilead Sciences GlaxoSmithKline infections Involving Off-Label Promotion issue regulatory letters issued during calendar letters citing off-label Letters That Cited Marcia Crosse medical professionals monitoring and surveillance Neurontin Off-label promotion cited otitis media OxyContin patients Paxil Pfizer Pharmaceuticals physicians Pravachol prescription drugs promotional activities promotional violations regulatory letters citing regulatory letters issued response to off-label review of submitted safe and effective sales representatives Settlements Involving Off-Label specific submissions submitted by drug submitted materials surveillance efforts symptoms Temodar Treatment untitled letter violative promotion Wyeth Pharmaceuticals Xyrem