FDA Defends Generic Drug Approvals Despite Dip in June

Regulatory NewsRegulatory News
| 12 July 2019 | By Zachary Brennan 

Despite just 45 generic drug approvals and 17 tentative approvals in June, the US Food and Drug Administration (FDA) told Focus that the dip­, from an average of about 89 approvals and 23 tentative approvals in the previous eight months, is not due to a specific issue.

“FDA approved or tentatively approved more than 900 ANDAs as of June 30, 2019, which is on par with (or above) previous fiscal years,” an FDA spokesperson told Focus. “Approval numbers can vary from month to month, due in part to the natural flow of action goal dates assigned to applications under the GDUFA II Commitment Letter and the dates on which abbreviated new drug applications (ANDAs) can be first approved from a patent or exclusivity perspective.”

For years FDA has been targeting the issue of multiple cycle reviews for ANDAs but said that it’s seeing improvements.

“The average number of review cycles and the overall time to approval is decreasing for newly submitted applications,” the FDA spokesperson said.

The only other time in recent years that the monthly approval numbers dipped as low as last month was back in January 2018 and February 2018, when a new deadline related to elemental impurities was put into place.

Robert Pollock, a senior advisor to Lachman Consultants who blogs about FDA’s generic approvals, told Focus: “Certainly if the trend continues it will be worrisome to the generics industry. There are still a lot of ANDAs sitting out there with CRLs [complete response letters] and many are minor amendments so you would actually expect the approval rate to pick up.”

The FDA spokesperson also noted this “significant increase” in communications on deficiencies, which he said helps to “demonstrate that our decreased time to approval does not come at the expense of our high approval standards.”

He also noted how in April, FDA updated all data for FY 2019 “to reflect an accounting change that provides a better representation of actual work done by the FDA Generic Drugs Program each month. The metrics web page footnotes were updated accordingly.”

FDA Activities Report


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