FDA: Most postmarketing requirements, commitments progressing on schedule
In its latest annual report on drugmakers’ performance in conducting postmarket requirement (PRMs) and postmarketing commitments (PMCs), the US Food and Drug Administration (FDA) says that most studies are progressing on schedule.Background
A PMR is a study or clinical trial that an applicant is required by statute or regulation to conduct following approval, while a PMC is a study or clinical trial that an applicant agrees in writing to conduct, but is not required by statute or regulation. PMRs and PMCs can be issued upon approval of a drug or biologic, or following approval, if warranted.
FDA categorizes PMRs/PMCs as open (pending, ongoing, delayed, submitted or terminated) or closed (fulfilled or released) and either on-schedule or off-schedule based on whether the applicant has missed a milestone date in the original schedule. Sponsors subject to PMRs/PMCs are required to submit an annual status report (ASR) within 60 days of the date of the product’s original approval or according to an alternate reporting schedule if granted by the agency.
FY2019 Report
As with the agency’s FY2018 report, FDA finds that most PMRs/PMCs “were successfully completed (fulfilled) or are progressing toward completion according to their original schedule.” (RELATED: FDA reports on status of postmarketing requirements and commitments, Regulatory Focus 6 August 2019).
As of 30 September 2019, FDA says there were 597 new drug applications (NDAs) with PMRs/PMCs held by 239 unique applicants and 173 biologics license applications (BLAs) with PMRs/PMCs held by 95 applicants.
According to FDA, 670 of those applications were required to submit ASRs in FY2019. Of those, 77% of ASRs for NDAs (395/515) were submitted on time, 14% were received, but not on time, and 9% were not yet received. For BLAs, 87% (135/155) were received on time and the remaining 13% were received late.
Combined, FDA says that 79% of open PMRs and 75% of PMCs for NDAs and BLAs are progressing according to schedule, with less than half of open PMRs listed as pending (46% of open NDA PMRs and 36% of open BLA PMRs).
By the end of FY2019, 22% of open NDA PMRs (238/1068) and 18% (57/315) of open BLA PMRs were off schedule. Of those, nearly all the off-schedule NDA PMRs (97%) were delayed and just six were terminated, while all 57 off-schedule BLA PMRs were delayed.
FDA also reported that most open PMCs were proceeding according to schedule, with 72% (124/173) of NDA PMCs and 78% (143/184) of BLA PMCs on-schedule. As with PMRs, a large portion of the on-schedule PMCs for both NDAs and BLAs, 38% and 25%, respectively, are reported as pending.
Most off-schedule PMCs for drugs and biologics were delayed, with only three NDA PMCs and one BLA PMC being terminated.
FDA reports that it considered most of the PMRs and PMCs that were closed in FY2019 to have fulfilled their requirements, with BLA PMRs/PMCs being fulfilled at a higher rate than those for NDAs.
According to FDA, 64% (114/117) of NDA PMRs that were closed in FY2019 were fulfilled, while 8% were released and given revised requirements and 27% were released because the requirement was considered infeasible or the product was withdrawn. For NDA PMCs, 81% (29/36) of those closed in FY2019 fulfilled their requirements.
Looking at BLAs, 89% of closed PMRs and 93% of closed PMCs were considered fulfilled, with the remainder being released because the requirement was no longer feasible or the product was withdrawn.