GDUFA Round 3: Opening Discussions

July 3, 2020By Sara W. Koblitz

Initially enacted in 2012 and reauthorized for the first time in 2017, the Generic Drug User Fee Act (“GDUFA”) was adopted to accelerate access to safe and improve the predictability of the generic drug review process.  FDA touts the GDUFA as a “remarkable success” that “demonstrates how FDA, industry and other stakeholders can work together to achieve tremendous results.”  Indeed, GDUFA was a product of extensive negotiation between the agency, the generic drug industry, and other stakeholders under which FDA agreed to adopt aspirational review timelines in exchange for fees paid to the agency by sponsors.  Initially, sponsors paid fees for review of Abbreviated New Drug Applications (“ANDA”), Drug Master Files, and Prior Approval Supplements, as well as annual fees for facilities generic drug facilities.  GDUFA II scrapped the supplement user fee in favor of an annual program fee based on the number of ANDAs a sponsor holds.

This summer, FDA begins negotiations with industry for GDUFA III.  GUDFA II expires at the end of fiscal year 2022 (September 2022), and FDA is soliciting public input on the path of the program going forward.  To that end, FDA will hold a (virtual) Public Meeting on the Reauthorization of GDUFA on July 21, 2020.  The meeting agenda has not yet been announced but will include presentations by FDA staff and stakeholder groups.  Public presentations are invited, and FDA will allot some time for public discussion.  To attend or speak at the meeting, register or email on or before July 7, 2020.  FDA will also accept public comments through August 20, 2020 to Docket Number FDA-2020-N-1459.

These types of meetings are a great opportunity for industry to air its grievances with GDUFA II.  Now that generic drug sponsors have had three years of experience with GDUFA II, there are undoubtedly some hiccups in the system that should be addressed.  Refunds often take years to process: maybe it is time to ask for some time commitments for review of refund requests?  Or maybe the consequences of failure to pay those fees are not adequate given that the last time a GDUFA-related Warning Letter was issued was 2015?   Whatever your gripe or praise of the system is, this meeting is a prime time for generic sponsors to give the Agency feedback on the amount of fees, the types of fees, and the consequences for failure to pay fees.  And, like everything this year, the meeting is virtual, so public presentations can be made without leaving the house.

More information about the Meeting will be posted on the Meeting Page as it becomes available.