Rounding Up And Down: Assessing FDA FY 2019 and FY 2020 Workload Estimates
Executive Summary
US FDA provides a few hints about upcoming industry application filing volume and the agency's assessment pace in FY 2020 budget documents.
The US FDA is not expecting a decrease in ANDA receipts in fiscal years 2019 and 2020, even though its budget request suggests that a drop will happen.
The agency wrote in its FY 2020 budget request congressional justification that after receiving 1,044 ANDAs in FY 2018, the agency expected to receive only 1,000 in FY 2019 as well as FY 2020.
Such an estimate may suggest signs of a slow-down in generic drug development and alarm industry and other stakeholders, especially those counting on increased generic competition to help lower drug prices. But the agency clarified that it is "not projecting a decrease in ANDA receipts" compared to FY 2018.
"Our data reflects GDUFA II program size which is based on 1,000 receipts per year," FDA told the Pink Sheet. "It is important to note that our projections are estimates and will be adjusted with the actual numbers once they are available. These estimates were provided by industry during the GDUFA negotiations."
Indeed, ANDAs are trending toward breaking the 1,000-submission barrier once again in FY 2019. After reporting 118 submissions in March, the total for the first half of FY 2019 was 512, which translates to 1,024 ANDA submissions by the end of the year. Sponsors on average submitted 1,030 ANDAs per year during GDUFA's first six years.
FDA said the estimate includes "the understanding that some years could have less than 1,000 receipts … and some years could have more." During three of GDUFA's first six years there were less than 1,000 ANDAs submitted, most recently in FY 2016.
Receipts are difficult for the agency to predict, in part because of the exterior forces that may affect the development pipeline. FDA stressed that the estimates in the budget request are derived from "rounding down a bit from the FY 18 numbers to get FY 19 and up a bit to get FY 20."
ANDA Approval Estimates Based On Prior Success, FDA Says
FDA also projected an increase in full and tentative ANDA approvals from 971 in FY 2018 to 975 in FY 2019 and 1,000 in FY 2020.
The agency said those figures were "based on historic data and the need to project for budget planning" and that it "concluded that recent years' approval and tentative approval success will continue in FY 2019."
Since FY 2015, FDA's actual approval output often has exceeded estimates, including in FY 2018. (See chart at end of the story.)
The agency issued a record number of full ANDA approvals in FY 2018, exceeding the mark set the previous year. However, industry wants the focus to shift to product launches, which trail the approval total. (Also see "US FDA Sets Generic Approval Record, But Generic Sponsors Aren't Celebrating" - Pink Sheet, 12 Oct, 2018.)
New Drug Submissions Steady, Promotional Submissions Increasing
FDA predicted no change in the pace of new drug submissions, saying in the budget request documents that after receiving 153 NDAs and BLAs in FY 2018, the same number is expected in FY 2019 and FY 2020.
Total NDA/BLA reviews, both priority and standard, also are expected to be remain the same at 70 and 141, respectively, in the current and upcoming fiscal years compared to FY 2018. Median review time for priority and standard NDAs and BLAs, also are estimated to be unchanged in FY 2019 and FY 2020 from FY 2018. (See sidebar.)
The agency is projecting increases in promotional material submissions in FY 2019 and FY 2020, an indication that FDA's Office of Prescription Drug Promotion will remain busy despite ongoing questions about its ability to regulate advertising content.
Promotional submissions are expected to increase more than 6% from the FY 2018 total of 107,108 to 114,000 in FY 2019, and then another 2% in FY 2020 to 116,500.
FDA's advertising enforcement letter totals have lagged in recent years, in part because of legal questions. The agency has decided to focus on promotional issues where health and safety may be involved. (Also see "Advertising Enforcement: US FDA Content To Let Competitors 'Duke It Out,' Woodcock Says" - Pink Sheet, 23 Sep, 2018.)
Workload Predictions To Improve With New Formula
FDA is hoping a potentially more accurate model now in development will improve its workload estimates and by extension better illuminate personnel needs.
The agency and industry recognized that using historical data to predict future workload and approvals is not ideal and is creating "more robust" forecasting algorithms "that take into account other factors beyond historical submission rates," FDA said.
Resource capacity plan capability development was included in the 2017 prescription drug, biosimilar and generic drug user fee reauthorizations, along with creation of a modernized employee time reporting system. FDA is expected to have the new capacity planning formula in place by October 2022, the end of the current user fee program cycle. (Also see "FDA May Not Implement User Fee Workload Adjuster In PDUFA VI" - Pink Sheet, 2 Apr, 2018.)