FDA poorly equipped to enforce off-label prescription drug marketing rules, GAO report finds

Jul 29 2008

FDA takes an average of seven months to issue warnings to pharmaceutical companies that market medications for off-label uses, and those companies take an average of four months to address the violations, according to a draft report compiled by the Government Accountability Office, the AP/Minneapolis Star Tribune reports.

The report found that FDA has no employees specifically assigned to monitor whether pharmaceutical companies market medications for off-label uses.

According to the report, FDA's Division of Drug Marketing, Advertising and Communications, which has 44 employees assigned to review prescription drug ads, monitors marketing for off-label use. The division examined about 68,000 prescription drug ads in total last year, the report found. The division seeks to prioritize misrepresentations in prescription drug ads that could affect human health but lacks a system to track all information received by FDA, according to the report. From 2003 to 2007, the division issued 42 notices of potential violations related to off-label use, most of which prompted pharmaceutical companies to end misrepresentations in prescription drug ads.

Sen. Chuck Grassley (R-Iowa), who requested the report, in a statement said that FDA "isn't keeping track of how drugs are marketed for off-label use, even though marketing for off-label use is illegal and it's the FDA's job to enforce that law." He added, "As a result, drugmakers aren't being held accountable for promoting unapproved use of medicine and patient safety is diminished" (Alonso-Zaldivar, AP/Minneapolis Star Tribune, 7/27).