US FDA Generic Approvals Peak In April, But Annual Pace Trends Down
Executive Summary
The April total is the highest monthly total in seven months, but only a few are first generics. Approval volume might continue rising if FDA does not find too many applications requiring in-person inspections, which were largely postponed as part of coronavirus containment measures, Robert Pollock, senior advisor and outside director to the board at Lachman Consultants, said.
Generic drug approval totals peaked in April as the US Food and Drug Administration’s Office of Generic Drugs continued its teleworking output surge.
Full and tentative approval totals reached their highest levels of fiscal year 2020 in April, although OGD remains on pace to report a significantly lower annual total than the previous year. The agency said there were 65 full approvals in April, as well as 22 tentative approvals. The full approval figure is the highest since August 2019 and the tentative approval total is the highest since January 2019.
OGD’s performance has improved since the coronavirus pandemic forced most FDA workers to telework. The office posted two of its three best months in FY 2020 during March and April, when telework orders were implemented. In addition, the two highest tentative approval totals so far in FY 2020 were posted in March and April. (See charts below.)
OGD saw the number of full ANDA approvals increase once teleworking began, which was attributed in part to fewer distractions and use of alternatives to in-person inspections. (Also see "Seven Days In March: NDA-BLA and ANDA Approval Output Diverged As Coronavirus Teleworking Began" - Pink Sheet, 29 Apr, 2020.)
Approval volume could continue rising if OGD does not find too many applications requiring in-person inspections, which were largely postponed as part of coronavirus containment measures, said Robert Pollock, senior advisor and outside director to the board at Lachman Consultants.
But there are too many variables to say whether virtual or in-person inspections could slow the approval pace, said Brian Malkin, counsel at Arent Fox.
The FDA told the Pink Sheet that CDER continues to meet user fee deadlines for non-coronavirus applications, but reiterated that “in the long-term, that work could be affected by an inability to conduct pre-approval inspections the way FDA did before COVID-19.”
“The generic drug program is experiencing an increase in prioritization efforts due to COVID-19 and continues to successfully meet goals for general submissions,” the agency said.
Averages Suggest Fewer Than 700 Full Approvals In FY 2020
The agency was averaging nearly 58 full approvals per month and 14 tentative approvals per month through April, a pace that is well-below the record annual totals OGD has posted the previous three fiscal years.
Through April, the agency approved 404 ANDAs and tentatively approved 98. Assuming the current averages hold through the remaining five months of the fiscal year, the agency would issue 693 full approvals and 168 tentative approvals for all of FY 2020. The full approval total would be the lowest since FY 2016, when 650 were reported and the tentative approval total would be the lowest since FY 2015, when 120 were reported.
OGD set a record in FY 2019 with 935 full approvals and 236 tentative approvals. (Also see "US FDA Generic Approvals Break 900 Barrier In FY 2019" - Pink Sheet, 16 Oct, 2019.)
Center for Drug Evaluation and Research Director Janet Woodcock has predicted the full and tentative approval volume would plateau because the agency had largely worked through a large bolus of backlogged applications that the agency was able to start clearing at the beginning of the generic user fee era. (Also see "ANDA Approval Records Will End As US FDA Mops Up Backlog" - Pink Sheet, 4 Dec, 2019.)
Non-First Generic Approvals Also Peak In April
The agency reported 61 of the full approvals in April were not first generics, beating the previous high of 56 posted in October 2019. FY 2020 is the first year the stat has been reported.
The four first generics approved in April were the second-lowest monthly total. In October 2019 and January 2020 the agency approved only one first generic.
The FDA, along with the White House, have prioritized increasing generic competition as part of a campaign to lower drug costs. (Also see "Drug Pricing Activity At US FDA May Be Unique To Gottlieb Tenure" - Pink Sheet, 30 Jan, 2020.) The campaign in particular encourages generic entry in markets where there are none. The agency published lists of products with no blocking patents or exclusivities to spark sponsor interest. (Also see "FDA's Off-Patent, Off-Exclusivity List Draws Few Takers Early On" - Pink Sheet, 4 Aug, 2017.)
ANDA Submissions Trending Near FY 2019, Supplements Increasing
ANDA submission volume remained about on the pace set in FY 2019, suggesting that, as expected, the generics pipeline remains strong.
OGD reported 69 submissions in April, which pushed the total for FY 2020 to 536. The agency received about 77 ANDAs per month during that time, which extrapolates to about 919 for the entire fiscal year.
That total would be slightly higher than the FY 2019 total of 909, but below the FY 2018 and FY 2017 totals of 1,044 and 1,306.
FDA officials predicted an increase in submissions in FY 2020 and FY 2021 compared to FY 2019. Data also suggested that the workload burden also may shift to supplements.
Through March, the mid-point of the fiscal year, the agency received 4,344 changes being effected (CBE) supplements and 510 prior approval supplement (PAS) submissions. Both are more than half of the totals received in all of FY 2019. (Also see "Generics Approvals Will Decline, US FDA Predicts, But Supplement Work May Grow" - Pink Sheet, 19 Feb, 2020.)