FUFRA Enacted; HP&M Issues Detailed Summary and Analysis

On September 30, 2022, President Biden signed into law the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, Division F of which is titled the “FDA User Fee Reauthorization Act of 2022” (“FUFRA”).   In addition to reauthorizing for an additional five fiscal years—Fiscal Years 2023-2027—several drug, biological product, and medical device user fee provisions that were scheduled to sunset on September 30, 2022, FUFRA reauthorizes—but only through December 16, 2022—several other statutory provisions that were scheduled to expire.

Unlike prior user fee reauthorizations, FUFRA does not include any “riders” addressing additional, non-user fee related statutory changes.  The limited reauthorizations will likely force Congress back to the negotiation table later this year to pass additional legislation that would extend those provisions through Fiscal Year 2027.  At that time, Congress may also consider various “riders” that were included in the House and Senate versions of FDA’s user fee program reauthorizations.

As we have done in the past for the initial and each quinquennial reauthorization of the drug and medical device user fee laws—in 1992, 1997, 2002, 2007, 2012, and 2017—Hyman, Phelps & McNamara, P.C. has prepared a detailed Summary and Analysis of FUFRA.  The memorandum summarizes each section of FUFRA and analyzes the new law’s potential effects on the FDA-regulated industry.