FDA In Brief: FDA issues annual report on efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs

August 6, 2019

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“The FDA takes very seriously its role in continuing to monitor and regulate the safety of drugs once they are on the market. The drug approval process requires rigorous testing and clinical trials, yet once a drug is approved, many more people may use the drug – and that is when new safety signals sometimes emerge. To fully understand a drug’s safety and benefits once used in the real-world population, we have the authority to ask that drug companies conduct additional studies following approval, called postmarketing requirements and postmarketing commitments, and we annually update the public on the progress of these important studies,” said Acting FDA Commissioner Ned Sharpless, M.D. “Our most recent report shows that in fiscal year 2018, the majority of these studies were successfully completed or are progressing toward completion according to the original schedule, with very few studies delayed. When studies are delayed, the FDA carefully assesses why and works with companies to meet their reporting expectations. But a delay doesn’t necessarily mean a study isn’t taking place – the study may be ongoing, but behind the original timeline because it was more difficult than anticipated to enroll participants in the clinical trial, or a complex study protocol required extended discussions between the applicant and the FDA. Additionally, emerging scientific information may result in a need to complete additional post-approval studies or to change the nature of the studies that we initially required, necessitating the company to modify timelines and protocols. We are committed to working with companies on these issues and holding them accountable for completing these important studies on time to ensure that our understanding of a drug’s safety and efficacy keeps pace with its use in all relevant populations once a product is approved. As we work to increase our body of knowledge about a drug’s performance, post-marketing studies have an important role to play. Patients and health care professionals deserve up-to-date, quality information to inform effective medical care.”

Today, the U.S. Food and Drug Administration released the Report on the Performance of Drugs and Biologics Firm in Conducting Postmarketing Requirements (PMRs) and Postmarketing Commitments (PMCs) Fiscal Year 2018 detailing the progress made by industry in fulfilling certain postmarketing studies. Once the need for a PMR or PMC is established, the company must report on the progress within 60 days of the anniversary date of the drug product’s approval until the FDA determines that the PMR or PMC has been fulfilled, is no longer feasible or would no longer provide useful information. All PMRs and certain PMCs are required to have a timetable for completion. Certain information about PMRs and PMCs is made available to the public in a searchable database. Results from completed post-market studies provide additional information that can lead to safety labeling changes, support expanded use of a drug, or alleviate concerns about a potential drug risk.

The fiscal year 2018 data shows that 69% of PMR/PMC annual status reports were received on time. For those that were open but not due, 79% for new drug applications and 86% for biologics license applications PMRs were progressing on schedule, and most open PMCs – 76% for new drug applications and 84% of biologics license applications – were also on schedule. Summary information about the status of PMRs and PMCs established from fiscal year 2012 to fiscal year 2018 is described in the report.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.