Legislative fix would allow FDA to collect GDUFA user fees

Legislation allowing the US Food and Drug Administration to collect several user fees under the Generic Drug User Fee Amendments of 2012 (GDUFA) is expected to be introduced this week (and perhaps voted on by both the US House of Representatives and the US Senate), notes Kurt Karst writing on Hyman, Phelps & McNamara’s FDA Law Blog.

A draft of the FDA User Fee Corrections Act of 2012 appeared on a web site maintained by the Office of the Clerk of the House earlier this week and would amend the FDC Act to address certain issues raised by language included in GDUFA, says Mr Karst.

Over the past month or so, there has been growing concern that, come October 1, 2012 when the GDUFA goes into effect, the FDA will be unable to collect several GDUFA user fees because of the failure by Congress to pass an FDA Appropriations Act for Fiscal Year 2013. This concern was exacerbated when the Continuing Appropriations Resolution, 2013 (HJ RES 117) was passed by the House last week making continuing appropriations for FDA in FY 2013 at FY 2012 levels and without any provisions concerning the collection of user fees provided for under the FDA Safety and Innovation Act (FDASIA).