Was this article helpful?00ByGad CohenOff-label use is the practice of prescribing pharmaceuticals for an unapproved indication,age group, dose, or administration. The Food and Drug Administration Center for Drug Evaluation and Research (CDER) reviews a pharmaceutical company's New Drug Application (NDA). Once the results from the clinical trials confirms a specific use and indication, then the manufacturer and the FDA agree on the specific language describing the information to be included on the drug's label and the drug's package insert.
Under the Food, Drug and Cosmetic Act (FDAC) at U.S.C. 21 manufacturers are prohibited from directly marketing a drug for a use other than the FDA approved indication. If a drug company discovers that its drug can be used to treat ailment B but it has only been approved for ailment A, the company cannot promote the new use.
Doctor's are the lasts ones to know about the drug's alternative applications. The prohibition on off-label drug communications causes unnecessary pain and hardships to patients suffering from cancer and HIV, for example.
The Federal Food, Drug and Cosmetic (FFDCA) of 1938 gave the FDA the authority to regulate drug promotion by pharmaceutical companies. These regulations give physicians the freedom to use their knowledge and prevent drug manufacturers from inappropriately influencing prescription use. Therefore, according to FDA regulations, doctors may prescribe drugs for off-label use, but drug companies may not promote such off-label indications
FDA regulations enforce that advertising and promotion practices are supported by clinical evidence and results and not be misleading.
The Food and Drug Administration Modernization Act (FDAMA) of 1997 created an exception to the prohibition of off-label marketing. Manufacturers are now able to provide medical practitioners with off-label information in response to an unsolicited request. The regulations postulated that information could be distributed only if the off-label use discussed was included in a filed or soon-to-be filed supplemental New Drug Application (sNDA).
On January, 2009, the FDA issued a new guidance that changed the FDAMA regulations regarding the distribution of scientific literature on off-label uses by manufacturers. The new guidelines allowed companies to distribute peer-reviewed scientific articles and texts describing off-label uses. The new policy is more permissive than the FDAMA, because manufacturers are no longer required to submit advance copies to the FDA and are not restricted to the distribution of journal articles on off-label uses for which they have filed or will file an sNDA.
Many other sources for off-label information are Compendia and drug information references, continuing medical education, journal articles, medical liaisons and web sites.
Gad Cohen has a Bachelor in Pharmacy and is a Medical Information Specialist having worked in the pharmaceutical industry for more than 15 years. For more information or questions please e-mail at leadermedicalinformation@gmail.com
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Cohen, G. (2012, March 21). . Retrieved April 8, 2012, from http://ezinearticles.com/?Off-Label-Medication&id=6953822Chicago Style Citation:
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