“A postmarketing requirement (PMR) is a study or clinical trial that an applicant is required by statute or regulation to conduct postapproval. A postmarketing commitment (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.” In previous years, the FDA as well as Congress has criticized firms for failure to submit annual progress reports documenting the status of PMRs and PMCs, as well as being critical of firms not meeting timelines for the completion and submission of the reports themselves. However, according to the FDA’s recently released report entitled, Report on the Performance of Drugs and Biologics Firms in Conducting Postmarketing Requirements and Commitments Fiscal Year 2021 (here), firms are currently doing better.

According to the report, the Agency can require firms to conduct certain postmarketing studies and clinical trials for the following goals:

  • To assess a known serious risk, assess signals of serious risk, or identify an unexpected serious risk related to the use of a drug product.
  • Under the Pediatric Research Equity Act (PREA), to study certain new drugs for pediatric populations, when these drugs are not adequately labeled for children.
  • To verify and describe the predicted effect or other clinical benefit for drugs approved in accordance with the accelerated approval provisions.
  • For a drug that was approved on the basis of animal efficacy data because human efficacy trials are not ethical or feasible.

There are a myriad of other studies that firms agree to conduct as part of post approval commitments when the Agency’s conditions approval of the application on undertaking and completing certain studies as agreed to at either the time of application approval or subsequent to approval. For both of these types of post approval reports there is a requirement to submit annual updates to the approved application. The FDA report notes that “Of the 566 NDA ASRs due in that fiscal year, 79 percent (446/566) were received on time, 12 percent (66/566) were received, but not on time, and 10 percent (54/566) were expected but not received during FY2021. Of the 186 BLA ASRs due, 78 percent (145/186) were received on time; 15 percent (28/186) were received, but not on time; and 7 percent (13/186) were expected but not received during FY2021.”  FDA cautions that comparing one time period to another may be a bit misleading due to the cohort year of the application.

The FDA report details studies and commitments where the status of the PMRs and PMCs are pending, ongoing, submitted, delayed, terminated, released, and fulfilled.  It describes what these terms mean in the context of the reporting requirements and gives context around the numbers.