Draft User Fee Bills Aim To Streamline And Strengthen Device Regs

Article preview from "The Gray Sheet"-  March 19, 2012

Details on draft legislation circulating in the House and Senate.

Draft User Fee Bills Aim To Streamline And Strengthen Device Regs

Article preview from "The Gray Sheet"-  March 19, 2012

"Discussion drafts" for FDA user fee reauthorization legislation that surfaced in the House and Senate last week have yet to incorporate language to actually reauthorize device user fees, but do already include significant provisions to reform FDA device oversight.

The device sections of the House draft package, generated by the Republican leadership on the Energy and Commerce Committee, are focused almost exclusively on streamlining the device center’s regulatory pathways, including the de novo, humanitarian device exemption and third-party review programs, and increasing FDA’s accountability to industry. Meanwhile, the Senate version, which is bipartisan, includes more of a mix, with some focus on facilitating the path to market, but also significant attention to improving device safety oversight.

The discussion drafts are just the starting point for the reauthorization of the user fee programs for devices, prescription and generic drugs, and biosimilars, all of which which expire Sept. 30.

FDA released draft proposed legislative language for device user fee reauthorization and a draft commitment letter March 15. FDA is presenting the plan to the House Energy and Commerce Committee and the Senate Health, Education, Labor and Pensions Committee, which will need to incorporate it into their broader user fee bills.

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