GDUFA III Talks Completed; Fees will Fund Inspection, Complex Generic Improvements
Executive Summary
Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.
US Food and Drug Administration and industry representatives have reached an agreement to extend the generic drug user fee program another five years, which will include enhanced communications on inspections, as well as additional clarity on so-called “imminent” ANDA approvals.
FDA confirmed on 2 September that the GDUFA III talks have been completed and the ratification process among the various industry and FDA stakeholders is under way. That process is expected to be completed in about a week. Later, the commitment letter text will be released and a public meeting scheduled.
Among the changes in the agreement is the addition of a post-warning letter meeting for sponsors to obtain FDA feedback on corrective and preventive actions (CAPAs), which are used in manufacturing to identify, investigate and correct, as well as prevent, product and quality problems.
The meeting should allow sponsors to ask questions and potentially avoid repeat mistakes, which could help reduce the number of assessment cycles prior to ANDA approval. Both sides also discussed the coronavirus pandemic’s impact on inspection requirements. (Also see "US FDA’s Drug Shortage Program On ‘Site Engagement’ To Be Nixed In GDUFA III" - Pink Sheet, 12 May, 2021.)
Adjustments also were made to imminent approval practices, according to information on the agreement obtained by the Pink Sheet. The FDA policy allows it to miss an assessment goal intentionally if an approval is close, rather than force another application cycle. Sponsors asked for annual reporting, as well as more senior management awareness, of affected products.
Imminent approvals typically are those that miss the goal date by 60 days or less. The FDA’s on-time decision rate during the second quarter of fiscal year 2021 reached the mandated 90% threshold because imminent approvals were included. (Also see "COVID-19 Supplement Approvals Jump, Some On-Time Decision Rates Slip For US FDA" - Pink Sheet, 30 Aug, 2021.)
FDA officials committed to the imminent approval idea for GDUFA II, but sponsors questioned when and how often the practice was employed. (Also see "ANDA Reviews Sometimes Miss GDUFA Goal Dates To Get Quicker Approval, But How Often?" - Pink Sheet, 18 Oct, 2019.)
Complex Generic Enhancements Upcoming
The FDA’s complex generic program also will undergo changes in GDUFA III as sponsors look for more ways to speed the products to market.
The GDUFA III agreement includes updates to the mid-assessment cycle meeting and post-complete response meeting processes.
Complex generics became a major theme of the talks, in part because the sector is becoming more popular among sponsors. Dan Leonard, president and CEO of the Association for Accessible Medicines, one of the trade associations that negotiated on behalf of industry, has said that complex generics still have enormous potential that has yet to be unlocked. (Also see "Generic Industry’s Future May Include A Role In The Gene Therapy Space" - Pink Sheet, 27 May, 2021.)
Bioequivalence and device issues often prevent or delay complex generics from entering the market. During GDUFA II, the agency unveiled new pre-ANDA formal meetings for complex product sponsors to help streamline the development and assessment process. (Also see "Complex Generics: US FDA, Sponsors View Roadblocks Very Differently" - Pink Sheet, 9 Feb, 2021.)
GDUFA Final Piece Of Human Drug, Biologic Fee Puzzle
GDUFA III talks ultimately required about the same amount of time as GDUFA II, even though the program was the last of the three FDA human drug and biologics user fee programs to complete that portion of the renewal process.
The talks began in September 2020 and included at least 34 meetings. The prior reauthorization talks lasted from October 2015 through August 2016 and required 38 meetings. (Also see "Predicting The User Fee Reauthorization Schedule" - Pink Sheet, 4 Feb, 2020.)
GDUFA III discussions reached the final stages in late July and August, as both sides began making final tweaks to the commitment letter language and resolved program revenue issues. (Also see "US GDUFA III Talks In Final Stages, Agreement Nearly Complete" - Pink Sheet, 12 Aug, 2021.)
Industry and FDA officials finished the prescription drug user fee reauthorization talks in February and published the resulting commitment letter in August. (Also see "PDUFA VII Commitment Letter Outlines Real-Time Review Expansion, Hiring Goals" - Pink Sheet, 23 Aug, 2021.) Biosimilar user fee talks ended in June, but that commitment letter has not yet been released. (Also see "Biosimilars Will Get Regulatory Science Program, Supplement Timeline Changes In Next User Fee Agreement" - Pink Sheet, 12 Jul, 2021.)
Once the commitment letters for the three user fee programs are completed and public comments solicited, they will be sent to Capitol Hill and packaged into legislation. PDUFA, BsUFA and GDUFA will expire 1 October 2022 absent reauthorization.