FDA Unlikely to Catch All Off-Label Drug Promotion Violations, Report Says

The FDA takes an average of seven months from the time it begins drafting to issue regulatory letters asking drugmakers to cease violative off-label drug promotions — and companies cited for serious violations take an average of four months to act, according to a new government study.

Although the agency issued 42 regulatory letters in calendar years 2003–2007 for violations of its rules for off-label promotions, it referred none to the Justice Department, which settled 11 civil and criminal actions involving such violations during that time, the Government Accountability Office (GAO) finds in its report, “FDA’s Oversight of the Promotion of Drugs for Off-Label Uses.” The settlements were for actions brought to Justice’s attention by sources other than the FDA, the GAO says.

Responding to a request by Sen. Chuck Grassley (R-Iowa), the GAO examined how the FDA oversees promotion of off-label uses and what actions were taken to address the practice.

The agency manages off-label promotion primarily by reviewing some of the materials it receives from drugmakers, but it does not have enough staff, does not systematically prioritize its reviews and “lacks a standardized tracking system to manage its review,” the GAO says. It recommended in its 2006 study of the agency’s oversight of direct-to-consumer advertising that the FDA institute a standardized tracking system to review off-label promotions, a recommendation it reiterates in its latest study.

The GAO concludes that “limitations in FDA’s oversight process make it unlikely that all off-label violations are detected.”