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Regulatory Focus™ > News Articles > 2019 > 8 > GAO Pushes FDA to Improve First Cycle Generic Approval Rate

GAO Pushes FDA to Improve First Cycle Generic Approval Rate

Posted 08 August 2019 | By Michael Mezher 

GAO Pushes FDA to Improve First Cycle Generic Approval Rate

In a report released Wednesday, the Government Accountability Office (GAO) calls on the US Food and Drug Administration (FDA) to take steps to improve the rate of first cycle approvals for generic drugs by increasing the clarity and consistency of reviewer comments.
GAO notes that FDA has worked to increase first cycle approvals in recent years but points out that the average generic applicant goes through three review cycles and that only 12% of generics were approved in the first review cycle in FY2015-2017.
While a 12% first cycle approval rate may seem very low compared to the first cycle approval rate for new drugs, which is often upward of 90%, it is a marked increase from prior to the enactment of the Generic Drug User Fee Amendments (GDUFA) in 2012 when the first cycle generic approval rate was less than one percent.
In January 2018, FDA issued a draft guidance and manual of policies and procedures covering good ANDA submission and review practices aimed at decreasing the number of review cycles ANDAs undergo before approval.
In response to the report, Acting FDA Commissioner Ned Sharpless said FDA supports GAOs findings and emphasized that the agency’s generic drug reviews have “become increasingly efficient” and that the number of review cycles for new ANDAs is decreasing.
GAO Report
Under the FDA Reauthorization Act of 2017, which reauthorized GDUFA and FDA’s other user fee programs through FY2022, GAO was instructed to investigate FDA’s first cycle approval rate and actions the agency has taken to boost first cycle approvals.
After reviewing the approval decisions for all ANDAs reviewed from FY2015-2017, GAO says it has identified steps FDA can take to improve the rate of first cycle generic approvals. Over that time period, FDA reviewed 2,030 ANDAs, 240 of which were approved or tentatively approved in the first review cycle.
While acknowledging that FDA has increased communication with ANDA applicants and developed templates for reviewers to follow, GAO says it found “variation in the clarity and content of FDA’s comments to applicants” that could have affected whether those applicants could adequately address deficiencies within the same review cycle.
GAO also reviewed a sample of 35 ANDAs to determine the specific deficiencies cited and communication between applicants and FDA reviewers. Of those, 26 applications were not approved in the first cycle, with the most commonly cited deficiencies being related to drug quality (356/435).
Facility inspections were also cited as a factor impacting first cycle approval. “Among the 26 applications we reviewed that were not approved, eight had an outstanding deficiency related to the manufacturing facility,” GAO writes.
GAO says that some of the stakeholders it interviewed “expressed concern that changes to the brand-name drug’s labeling mid-cycle could delay or prevent generic drugs’ approval in the first cycle,” with some stakeholders claiming such labeling changes “may be strategically timed to delay approvals.”
FDA officials interviewed by GAO pushed back on those claims, stating that, “It would be difficult for brand-name companies to time labeling changes in this way,” but acknowledged that the agency does not track the timing of labeling changes.
GAO, Report

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