Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Amendments (MDUFA), on August 3, 2017, the Senate passed the FDA Reauthorization Act (FDARA). FDARA reauthorizes the user fee programs, which fund much of the operations of the Food and Drug Administration (FDA), for the five-year period beginning October 1, 2017. President Trump is expected to sign FDARA into law.
In addition to setting fees relating to innovator and generic drugs, biologics and biosimilars, and medical devices, and reauthorizing several related programs, FDARA also contains numerous riders of note, summarized briefly below:
There are several benefits to receiving a competitive generic therapy designation, including increased communication and meetings with the FDA during the drug development process, and cross-disciplinary review. Perhaps most importantly, drugs designated as competitive generic therapies are eligible for 180-day marketing exclusivity.
Specifically, in certain circumstances in which the FDA denies a request for a CFG, the agency is required to provide the basis for denial in writing and provide a process to request a review of a denial. An inspection report is not permitted to be the sole basis for denial, if a corrective action plan is in place. Both domestic and, under certain circumstances, foreign establishments are eligible for CFGs. Finally, the FDA is to issue draft guidance on this process within one year after enactment and final guidance within one year after the draft guidance comment period closes.
These provisions enable a sponsor to request that the FDA independently classify an accessory as part of a 510(k) or pre-market approval (PMA) submission for the parent device. In addition, for accessories that have already been granted marketing authorization as part of a submission for its parent device, (i) the FDA will propose a list every five years in the Federal Register of accessories that are suitable for a Class I classification, and (ii) there is a new process for sponsors to submit a written request to FDA for appropriate classification of an accessory.
In addition to the user fee legislative package, the FDA issues a Commitment Letter for each user fee program to capture the agency’s recommendations for the reauthorizations, and performance goals for fiscal years 2018–2022. Several commitments in both the PDUFA VI and MDUFA IV Commitment Letters relate to, or otherwise complement, the user fee legislation riders and are described below.
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The provisions in FDARA are intended to foster innovation, improve the FDA’s efficiency and advance medical product safety. However, FDARA and the accompanying commitment letters only establish a framework; many of the details will be determined by guidances and informal procedures that the FDA adopts over the coming months and years. It is important that industry and other stakeholders engage with the FDA as the agency implements FDARA to ensure that the legislation achieves its full potential.