Second Quarterly Activities Report of the Generic Drugs Program FY 2021 Released

The FDA released its Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance for the second quarter of FY 2021 late yesterday.  And there were not any real surprises.

The number of ANDAs awaiting FDA action continues to decrease over the figures for FY 2020, while the number of ANDAs awaiting applicant Tentative Approval (TA) increased over FY 2020 figures but not by much.  The 2020 report can be viewed here for comparative purposes.

ANDAs awaiting applicant action dropped significantly over the first 2 quarters of FY 2020 when the number were 1755 and 1831, respectively.  However, now the numbers are reflective of the last 2 month figures reported in the FY 2020 report.

Mean approval times fluctuate greatly from quarter to quarter, but there has not been a real significant drop in that metric over the past two years. Mean approval times also fluctuate but not as greatly but are higher in the first two quarters in FY 2021 than in FY 2020.

Mean TA approval times are consistent with those seen for last FY, but median TA times appear to be climbing slightly.

For all the work the Agency puts in to gather this data, it does not really provide much useful information to the industry but is it something that is required under the GDUFA II negotiations.  With the high degree of “bounce” in the data, it is really difficult to see any reasonable trends and reviewing the specific data sets does not (in my opinion) show much meaningful change.  Perhaps industry needs to look at different metrics that would be more reflective of whether the Agency is improving or if GDUFA is having the desired effect of significantly shortening approval times, reducing the number of review cycles, or improving industry performance. Should industry be looking at metrics that provide a better barometer of GDUFA Goals during its GDUFA III negotiations? Maybe.