FDA: Majority of applicants complied with postmarketing requirements, commitments

The US Food and Drug Administration (FDA) reported that most drug and biological manufacturers satisfied their postmarketing requirements (PMR) and postmarketing commitments (PMC) during fiscal year 2023, according to the agency’s latest annual report.

FDA requires applicants of approved drugs and biological products to conduct a PMR if there is a known serious risk associated with the drug or if the product is not adequately labeled for children, as mandated by the Pediatric Research Equity Act (PREA). Additionally, the FDA may require a PMR to verify the predicted effects or other clinical benefits of drugs that were approved under accelerated approval. A PMR is also necessary when products are approved based on animal efficacy data due to ethical or feasibility concerns surrounding human efficacy trials.

A PMC is a postapproval study or clinical trial that the applicant agrees to conduct in writing, which is not mandated by statute or regulation.

The report found that the majority of PMRs and PMCs have been fulfilled or were proceeding according to schedule.

The agency classifies PMRs and PMCs as either open or closed, and as either on-schedule or off-schedule, depending on whether they have met their milestone dates. Open PMRs/PMCs can be categorized as pending, ongoing, delayed, submitted, or terminated. In contrast, closed PMRs/PMCs are classified as either fulfilled or released.

As of 30 September 2023, the FDA says 279 NDAs with PMRs/PMCs were held by unique applicants and 120 BLAs with PMRs/PMCs.

There were 759 NDAs and BLAs with an annual status report (ASR) due in FY 2023. This includes 549 NDAs and 210 BLAs. Of the 549 NDA ASRs that were due, 82% were submitted on time, while 70% of the 210 BLAs were submitted punctually.

FDA also reports that in FY 2023, 70% of the open PMRs for NDAs and BLAs were on schedule, while 30% were not. For PMCs, 78% of the NDAs and BLAs were proceeding as planned, whereas 22% were off schedule.

Out of the total 1,098 PMRs that were open in FY 2023, 41% are waiting for safety studies, 23% are awaiting PREA studies, 5% are waiting for accelerated approval studies, and 1% are awaiting animal efficacy studies.

The report indicates that an average of 295 PMRs have been established each year since FY 2017, with most PMRs from the earlier years either fulfilled or released. For instance, in FY 2023, 51% of the PMRs established in FY 2017 were fulfilled, while 21% were released. However, a significant number of PMRs required in more recent years are either pending or ongoing. Specifically, in FY 2023, 92% of the PMRs established in FY 2023 were pending, and only 3% were ongoing. Overall, 77% of all PMRs are currently pending.

The report reflects combined data from FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research and addresses the number of applicants with open PMRs/PMCs and the number of closed ASRs. Sponsors subject to PMRs or submitting PMCs must submit an 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.

Report

FDA: Majority of applicants complied with postmarketing requirements, commitments

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