Updated: GDUFA II Performance Goals: 8-Month Priority Reviews, More Timely Correspondence

Regulatory NewsRegulatory News | 17 October 2016 |  By 

The US Food and Drug Administration (FDA) will speed the review of abbreviated new drug applications (ANDAs) and work with generic drugmakers on a closer and more timely basis, according to the draft performance goals and program enhancements for the Generic Drug User Fee Act (GDUFA) reauthorization for FYs 2018-2022, known as GDUFA II.

The GDUFA II performance goals letter, released last Friday, follows more than a year of negotiations between FDA and the generic drug industry and the fruit of their labor could result in not only faster approvals and structured commitments to deal with backlogged ANDAs, but new features, like eight-month priority reviews and enhanced communications, as well as a massive boost in the amount of user fees the industry will pay to FDA. 

The speed at which FDA reviews and approves ANDAs has been in focus recently as one of the reasons for spiking drug prices. And even though the agency has brought on more than 1,000 new employees to speed a once-lagging backlog, the agency's impact on drug prices does not seem to have had an impact on at least 315 generics, which have doubled in price since 2010, including many without competition.

With those issues in mind, FDA and the generic industry took some significant measures to improve GDUFA in its latest iteration.

For instance, FDA says that under GDUFA II, it will “strive to determine whether to receive an ANDA within 60 days of the date of ANDA submission,” which will give sponsors, a higher number of which received complete response letters in 2016 than any previous year, a more prompt reply on why their submissions might be deficient.

The Generic Pharmaceutical Association (GPhA) said it is optimistic that the provisions of this agreement will streamline approvals by assigning goal dates to all ANDAs so that no submissions from GDUFA I are left behind. 

Review Goals

The goals letter includes the expected and oft-mentioned faster reviews of generics, with the goal of reviewing and acting on 90% of standard original ANDAs within 10 months of the date of ANDA submission (by comparison, in 2012, FDA set its goal of reviewing and acting on 60% of original ANDA submissions within 15 months from the submission date).

FDA will also feature a new priority review for generic applications, with the goal of reviewing and acting within eight months of the date of ANDA submission (if the applicant submits a complete and accurate Pre-Submission Facility Correspondence two months prior to the date of ANDA submission) or within 10 months of the date of ANDA submission if the applicant does not submit such Pre-Submission Facility Correspondence.

ANDA amendments will also see quicker reviews, with FDA reviewing and acting on such amendments within eight months (or six months for priority reviews) of submission if a preapproval inspection is not required and within 10 months if such an inspection is required.

FDA also mentions cases where with an ANDA or prior-approval supplement (PAS) (FDA also finalized guidance on PASs under GDUFA on Friday), the review classification could change from a standard to priority review, in which case FDA says it will notify the applicant within 14 days of the date of the change.

New User Fee Structure

According to the new fee structure plan for GDUFA II, the generic industry will pay almost $200 million more annually than under GDUFA I ($493.6 million annually under GDUFA II and adjusted each year for inflation).

That significant increase comes as FDA notes that GDUFA I was built on the assumption that the agency would receive 750 ANDAs annually, but over the first four years of GDUFA I, FDA actually averaged about 1000 ANDAs per year.

"To address the increased workload, FDA hired additional staff and is projected to spend about $430 million in the final year of GDUFA I. In order to maintain FDA’s current productivity and implement negotiated improvements, Industry and FDA agreed that user fees should total $493.6 million annually adjusted each year for inflation," according to the summary.

In addition, FDA is taking small generic companies into account with GDUFA II.

For instance, under GDUFA I, facilities would pay an annual fee if it was listed in an ANDA, regardless of whether it was listed in any approved ANDAs (so facilities listed only in pending applications could be charged an annual fee even though it had no generic drug revenue stream).

Under GDUFA II, however, no facility or ANDA sponsor would be charged an annual fee until an ANDA in which it is listed is approved. Also, a firm and its affiliates will pay one program fee under GDUFA II that is commensurate with the number of approved ANDAs that the firm and its affiliates collectively own. In addition, contract manufacturing organizations will be a part of GDUFA II and pay one third the annual fee paid by firms that manufacture under ANDAs. 


In addition to determining whether to receive ANDAs within 60 days of a submission, FDA pledges to review and respond to 90% of standard controlled correspondence within 60 days of the date of submission, and review and respond to complex controlled correspondence within 120 days of submission.

And in terms of information requests (IRs) and discipline review letters (DRLs), FDA says it will issue the appropriate ones from each review discipline as soon as the review is completed, “with the first IR(s) and/or DRL(s) at about the mid-point of the review.”

FDA also says it will continue to issue IRs and/or DRLs late in each review cycle in order for applicants to develop and FDA to review complete responses to the IR and/or DRL.

And FDA will grant or deny 90% of Product Development Meeting requests within the applicable goal, which for FYs 2018 and 2019 is 30 days from receipt of the request, while for FYs 2020, 2021 and 2022, the goal is 14 days from receipt of the request.

In terms of setting forth procedures for filing reviewers on communication of minor technical deficiencies (e.g., document legibility) and on deficiencies potentially resolved with information in the ANDA at original submission, FDA says it will issue a MAPP by 1 October 2017 in order to provide applicants with an opportunity for resolution within 7 calendar days.

“If such a deficiency is resolved within 7 calendar days, that deficiency will not be a basis for a refuse-to-receive decision,” the agency said.

Helping Generic Drug Developers

FDA will also issue product-specific guidance identifying the methodology for developing drugs and generating evidence needed to support ANDA approval, for 90 percent of new chemical entity New Drug Applications that are approved on or after 1 October 2017, at least two years prior to the earliest lawful ANDA filing date.

The agency is holding a public meeting on the draft goals letter this Friday, 21 October, at its White Oak campus from 9 a.m. to 5 p.m., but comments can be submitted until 7 November.


Editor's note: Story updated on 10/18/16 with new information on the user fee structure.


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