President Signs Law Reauthorizing Drug And Device User Fees: Legislation Contains Several Important FDA Reforms

On Monday, July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). This statute reauthorizes the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA), which provide a significant portion of FDA's funding for new product application review. In addition to reauthorizing these user fees, FDASIA includes a number of provisions affecting FDA regulation of drugs and medical devices. Several of the most controversial proposals ultimately were not included in the legislation, including a provision that would have established a national "track and trace" program for drugs and a provision that could have delayed FDA's ability to regulate mobile medical devices. This alert briefly summarizes the law's most important provisions.

Key Provisions in FDASIA

User Fees: In addition to reauthorizing prescription drug and medical device user fees, FDASIA introduces new user fees for generic drugs and biosimilar product applications. Generic drug fees: FDA will establish user fees for generic drug applications for the first time, based on the total amount of such fees authorized by Congress ($299 million for FY 2013, with $50 million designated for a one-time backlog fee); Biosimilar biologic fees: FDA will establish several new user fees for biosimilar biologic products. These include: an initial development fee, to be assessed for the submission of a request for a biosimilar biologic product development meeting, or the submission of a clinical protocol for an IND; an annual development fee, due each year following the initial development fee until a marketing application is accepted for filing by FDA, or program participation has discontinued; and, an application fee. Product application fee: If clinical safety or efficacy data is required for approval, the fee will be equal to the amount determined by the Secretary minus the cumulative amount of fees paid for that product (i.e., development fees). If safety or efficacy clinical data is not required, the fee will be equal to half the Secretary-established amount, minus cumulative fees paid to date. Transition rule: an initial product development fee will be assessed for IND applications submitted prior to the bill's enactment, due at the earlier of 60 days after the bill's enactment, or five days after the Secretary grants a meeting request. Medical Device Regulatory Improvements: FDASIA includes a...