FDA Finalizes PDUFA User Fee Guidance

By Michelle L. Butler –

On September 27th, FDA published a guidance document regarding user fee waivers, reductions, and refunds for drug and biological products.  See 76 Fed. Reg. 59705 (Sept. 27, 2011); FDA, Guidance for Industry: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (Sept. 2011).  This is a final version of the document FDA published in draft in March 2011, which we described in detail here.  

According to the Federal Register notice that announced publication of the guidance document, the Agency received no comments in response to its request for comments on the draft guidance document earlier this year, and the only changes to the guidance document were minor editorial changes and a small clarification.  This clarification pertains to the determination of whether an applicant has limited financial resources for purposes of the public health and barrier to innovation waiver grounds.  FDA clarified that $20 million benchmark for determining that an applicant has limited resources for user fee purposes will begin with fees assessed for FY 2011.  Guidance, at 8.  For waivers of fees for fiscal years prior to 2011, “the Agency intends to continue to use as its general market of limited resources the $10 million benchmark cited in the 1993 interim guidance, adjusted for inflation.”  Id. at 8, n.20.