FDA Reports on Status of Postmarketing Requirements and Postmarketing Commitments

The FDA has released its annual Report on the Performance of Drugs and Biologics Firms in Conducting Postmarketing Requirements (PMRs) and Postmarketing Commitments (PMCs) for Fiscal Year (FY) 2022. The agency reported that applicants successfully completed or released most of the PMRs/PMCs for the year reported on. Few PMRs/PMCs are delayed, with the majority moving along according to schedule.

As stated by the FDA, a PMR is “a study or clinical trial that an applicant is required by state or regulation to conduct postapproval” (1). A PMC is “a study or clinical trial that an applicant agrees in writing to conduct postapproval, but that is not required by statue or regulation.” PMRs and PMCs can be instituted as a condition of an approval or post approval of a drug. There are various reasons that the agencycan require application holders to conduct postmarketing studies and clinical trials, such as: to assess a known serious risk, assess signals of that risk, or identify a serious risk related to the use of a drug product; to study new drugs for pediatric patients, if these drugs are not properly labeled for children; to verify and describe the effect or clinical benefit of drugs that have been approved with accelerated approval provisions; or for a drug which human efficacy trials are not ethical or feasible, and therefore was approved on animal efficacy data.

The FDA requires applicants of approved drugs and licensed biological products to submit annual reports on the status of each clinical safety, clinical pharmacology, clinical efficacy, nonclinical toxicology study, or clinical trial that the applicants have committed to conducting or were required by the agency to conduct. They are required to report to the FDA on the requirements and commitments made for new drug applications (NDAs) and abbreviated new drug applications (aNDAs).

This report combines data from both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) and provides information on PMRs/PMCs as of September 30, 2022. As of the date of reporting, there were 386 unique applicants with open PMRs/PMCs under 798 unique NDAs and biologics license applicants (BLAs). There were 277 unique NDA applicants (and 591 associated applications) and 109 unique BLA applicants (and 207 associated applications) with open PMRs/PMCs. Applicants must submit an annual status report (ASR) on the progress of each open PMR/PMC within 60 days of the US approval of the original application or an alternate reporting date that was granted by FDA. There were 746 NDAs and BLAs with an ASR due in 2022 (547 NDAs and 199 BLAs). Of the 547 NDA ASRs due, 83% were received on time, 10% were received late, and 7% were expected but not received. Of the 199 BLA ASRs due, 82% were received on time, 14% were received late, and 4% were expected but not received.

Reference

1. FDA. Report on the Performance of Drugs and Biologics Firms in Conducting Postmarketing Requirements and Commitments Fiscal Year 2022 (CDER/CBER, 2022). https://www.federalregister.gov/documents/2024/04/23/2024-08649/report-on-the-performance-of-drug-and-biologics-firms-in-conducting-postmarketing-requirements-and