New Program Urges Doctors to Report Illegal Drug Promotions
According to the Congressional Budget Office, the pharmaceutical industry spends nearly three times as much on advertising to health care professionals as they do advertising to consumers. The FDA's Division of Drug Marketing, Advertising and Communications announced yesterday the implementation of the "Bad Ad Program" which is part of a wider effort to intensify the FDA's enforcement of illegal drug marketing. Physicians are encouraged to report any potential violation of drug promotion rules (i.e. recommendations or suggestions by drug representatives for unapproved or "off-label" uses for any drug, promotion that is false or misleading, etc.) that occurs in private situations such as doctor's offices, dinners, and medical conferences. This also applies to written or printed promotional materials that are distributed directly to doctors.
Under the Bad Ad Program, physicians are urged to email to badad@fda.gov or call (877) Rx-DDMAC to report any potential violations of drug promotion rules. Under the federal Food, Drug, and Cosmetic Act, a drug manufacturer must be specific as to the intended uses of a product in its initial drug application to the FDA. Once the drug is approved, a drug company cannot market or promote the drug for purposes not specifically outlined in the drug's application.
