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FDA Failing to Monitor Unapproved Uses of Drugs

Jul 28, 2008 | Parker Waichman LLP

Federal regulators are not doing enough to stop drug makers from promoting unapproved uses of medications, according to a new report.  Even when the Food & Drug Administration (FDA) does catch a company promoting a so-called off-label use of  a drug, it can takes months for the agency to the act.  

Drug companies are prohibited from promoting medications for uses that have not been validated by the FDA on evidence from clinical trials. Doctors, however, can prescribed medicine in any way they see fit. Also, under guidance proposed by the FDA this year, drug companies could distribute to doctors scientific articles that suggest new and unapproved uses for medications.

Off-label use is common - a 2006 study suggested that more than 20 percent of prescriptions written in the US are for off-label use. The situation has gotten the attention of Senator Charles Grassley (R-Iowa), a frequent critic of the pharmaceutical industry.  Charles Grassley asked the Government Accountability Office (GAO) to investigate off-label use over concerns Medicare and Medicaid are paying out too much for medications used for unapproved purposes,  while pharmaceutical companies promote off-label uses just to shore up their profits.

The FDA is supposed to take action against companies that illegally promote off-label use.  But according to the GAO's draft report, it takes the FDA an average of seven months to issue a warning to companies employing such marketing practices.  It can take a drug maker as long 4 months to comply with an FDA warning.

The GAO also found that the FDA doesn't have the resources to catch even the most obvious violations of off-label use promotion rules.  The agency does not  even have any staff exclusively assigned to monitor whether companies are following off-label marketing rules.  Rather, that job is delegated by FDA office that oversees all drug advertising, including television commercials and magazine ads. Last year, that office - with only 44 full-time employees - had to review the fine print on some 68,000 drug ads.  It is not surprising that the office is doing a poor job of  monitoring and tracking off-label use and promotion of drug.


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