Compounders get version of PDUFA
The FDA is looking to get compounders to fill the inspection kitty. Regulatory Focus reports that the FDA has issued draft guidance that would allow the agency to collect fees from compounders, much as it collects PDUFA fees to fund drug reviews. RF notes that lawmakers approved the fee last fall, following a compounding crisis which killed more than 60 people, and during which the FDA said it lacked funding and authority to supervise compounders.
The approved legislation, known as the Drug Quality and Security Act, gave the FDA regulatory authority over what were deemed “outsourcing facilities.”
The fees described in today's RF pay for this supervision and include an annual $15,000 "establishment fee" ($5,000 for small businesses) and a $15,000 re-inspection fee. The guidance also includes an incentive: register as an oursourcing facility before October 1—the end of FY2014—and you don't have to pay that year's fees. These firms would still have to pay FY2015 fees.