Congress Must Clarify FDA Authority Over Compounders: GAO

As Congress gears up to consider controversial legislation for overseeing compounding pharmacies, a new report from the Government Accountability Office largely confirms the stance taken by the FDA – that the authority of the agency to regulate these businesses is unclear due to different court rulings and differing views about pharmacies that sell large quantities of compounded drugs over state lines. The GAO, in particular, reiterated concerns raised earlier by FDA officials that not only have federal court rulings resulted in a patchwork approach to oversight across the US, but sometimes, the agency has had to obtain search warrants to pursue inspections. In a recent interview, FDA officials stressed such hurdles stretch resources and add time to the inspection process, which can affect patient safety (here is the interview). The report also noted, however, that the FDA needs to improve its database for collecting reliable and timely information on compound pharmacy inspections and enforcement actions. The agency databases need to “clearly differentiate” operations that FDA inspects for good manufacturing practices and those that are not approved and not inspected, so there is also more clarity available to state regulators (here is the GAO report). The controversy over compounding pharmacies, you may recall, erupted last fall following an outbreak of fungal meningitis tied to a Massachusetts compounder. So far, 749 cases, including 61 deaths, have been reported and ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs