GAO: Generic drug approvals too slow

August 13, 2019

While FDA’s drug approval time is generally improving, the agency needs to speed up generic drug application reviews, according to a new report.

While FDA’s drug approval time is generally improving, the agency needs to speed up generic drug application reviews, a new report said.

FDA approved only 12% of 2,030 generic drug applications in the first cycle from 2015-2017, according to the Government Accountability Office (GAO) report.

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After reviewing an application, FDA may return it with comments. The pharma maker can address the comments and resubmit. On average, applications go through 3 of review cycles before approval-a process that could take years, GAO said.

While FDA has taken steps to increase the rate of generic drug approvals in the first review cycle, “GAO’s review of a judgmental selection of 35 applications found examples of variation in the clarity and content of FDA's comments to applicants. Such variation may have contributed to whether applicants could adequately address deficiencies within the first cycle, and therefore whether the applications were approved.”

Stakeholders GAO interviewed also expressed concern that changes to the brand-name drug's labeling mid-cycle could delay or prevent generic drugs' approval in the first review cycle. “Some stakeholders said they believe that the labeling changes may be strategically timed to delay approvals,” GAO said.

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“Although FDA officials noted that it would be difficult for brand name companies to time labeling changes in this way, they said that the agency has not conducted analysis that would enable it to assess the validity of these concerns. Therefore, FDA lacks the information needed to respond to these concerns or address problems should they exist,” GAO said.

FDA supports the findings of the report, Acting Commissioner Ned Sharpless, MD, acting FDA Commissioner, said in a tweet. “From the report, it’s evident GAO recognizes the challenges we face in reaching first-cycle approvals,” Sharpless tweeted.

However, Sharpless defended FDA’s actions on generic drug approvals. “Over the past few years, FDA has been deeply committed to improving the efficiency of our generic drug program & has focused on providing helpful, clear advice to industry in order to facilitate drug competition,” he tweeted.

“It’s not enough to bring more generics to market, consumers must also have confidence in the safety and quality of generic medicines. Through our review and approval process, we help ensure the safety, effectiveness and quality of all FDA approved generics,” Sharpless added.

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