Expert: OGD on track to approve more generic drugs in FY2022

Regulatory NewsRegulatory News | 12 August 2022 |  By 

The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) will most likely approve a higher number of generic drugs in FY2022 compared to the prior year, and the number of generic applications received may continue to exceed OGD’s review capacity, asserted Robert Pollock, a senior advisor with Lachman Consultants.
Pollock, who regularly writes about FDA’s generic approvals, spoke to Regulatory Focus and shared these observations in his recent blog. His predictions were based on FDA’s monthly activities report for July 2022.
He estimates that, based on current trends, FDA will approve about 877 generic drugs, 695 of which will be full approvals and 182 will be tentative approvals.
In FY2021, FDA approved 836 generic drugs, with 669 full approvals and 157 tentative approvals, said Pollock. This may reverse the overall trend of declining generic drugs approvals, according to OGD’s annual report issued early this year. (RELATED: Generic drug approvals continued to fall in 2021, Regulatory Focus 16 February 2022)
Through July, FDA approved 731 generics drugs, with 579 full approvals and 152 tentative approvals.
He further projected that the number of receipts may continue to exceed OGD’s review capacity, and the agency will receive 842 submissions in FY2022, up from 809 in FY2021. “The delta between ANDA approvals and receipts in FY 2021 was 130 and, if the numbers hold for FY 2022, we project that delta will be 147; the gap has widened from 26 in 2019 and has gone up in both FYs 2020 (128) and 2021 (130),” he wrote.
Another noteworthy trend, said Pollock, is the high number of complete response (CR) letters issued in July, which are issued to applicants for deficient applications. OGD issued 171 CRs in July, which was the second highest number behind January’s issuance of 195 CRs.
Yet the overall number of CRs issued by OGD has continued to decline over the past five years, going from 2,648 in FY2018, to 2,310 in FY2019, to 2,010 in FY2020, to 1,851 in FY2021, with 1,833 CRs projected for FY2022.
At the same time, he told Regulatory Focus, the number of refuse to receive (RTR) letters have started to “creep up” over the last three years, which Pollock attributes to new entrants in the generics market. He said he hopes this does not indicate a “backslide” by industry or “OGD getting more stringent with new requirements.”
The agency also appears poised to approve more first-time generics compared to past years, and has already approved 100 so far this year, surpassing 93 first generics approved in FY2021. First generics provide access to therapies where no competition previously existed.
Lachman said this bump “is not unexpected” since first time generics are accorded priority review, and thus, can be reviewed faster. Another reason: due to the race to be a first approval, firms are “paying more attention to the details of the initial submission or response to a first CRL.”


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