FDA Reports on Status of Postmarketing Requirements and Commitments
Posted 06 August 2019 | By
The US Food and Drug Administration (FDA) on Tuesday released a report on drugmakers’ performance in conducting postmarketing requirements (PMRs) and postmarketing commitments (PMCs) in FY2018 that finds most of the studies are progressing on schedule.
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 postapproval, but that 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 sponsor 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.
“The majority of these studies were successfully completed or are progressing toward completion according to the original schedule, with very few studies delayed,” said Acting FDA Commissioner Ned Sharpless, noting that there are multiple legitimate reasons for studies to be delayed, such as difficulty enrolling participants or extended discussions between FDA and a sponsor regarding the study protocol.
According to the report, there were 318 sponsors with open PMRs/PMCs for 755 unique drugs and biologics as of 30 September 2018. Of those, 581 PMRs/PMCs were for new drug application (NDA) products and 174 were for products marketed under a biologics license application (BLA).
FDA says that 719 of those products (569 NDAs and 150 BLAs) had PMRs/PMCs with an ASR due in FY2018.
Of those, 69% of the reports for NDA products were received on time, 13% were submitted late and 18% were not received by the end of the fiscal year. The data was similar for BLAs, with 69% of reports submitted on time, 11% submitted late, and 21% expected but not yet received.
As with its previous report
, FDA says that most PMRs and PMCs are progressing on schedule, with 81% of open PMRs and 80% of open PMCs being on schedule as of 30 September 2018.
But FDA also notes that “nearly half [44% and 47%] of the open NDA and BLA PMRs were pending” at the end of FY2018, with 28% of NDA PMRs and 30% of BLA PMRs marked as “ongoing”.
Looking at the PMRs that were open and off-schedule, FDA says that 21% of open NDA PMRs and 14% of open BLA PMRs were off-schedule. Of the off-schedule open PMRs, 98% were delayed and only a handful (4 NDA and 1 BLA) were terminated.
FDA notes that, for the purpose of the report, studies were considered delayed based on their original timetables and that the report does not consider whether the agency subsequently acknowledged that more time would be required to conduct the studies.