The FDA should have a plan for postmarketing safety monitoring of each drug that it approves, according to a report recently released by an Institute of Medicine (IOM) committee. The report also offers general guidelines for when the agency should require a postmarketing safety study.
Each drug’s Benefit and Risk Assessment Management Plan (BRAMP) would be publicly available and would include a description and risk-benefit assessment of any safety questions that exist when the drug is approved, as well as any that emerge once it is marketed, along with details on any regulatory actions taken and their results. Much of this information is already gathered by the FDA, the committee noted, although it is not centralized and easily accessible.
In general, the committee recommended that postmarketing safety studies be required when regulatory decisions can’t be made with existing safety evidence, when research can be designed to help inform a regulatory decision that can be made in a timely fashion, and when the rights and interests of research participants can be adequately protected. The committee notes that randomized controlled studies may be difficult to conduct once a drug has been approved, so observational studies may be preferred for postmarketing safety evaluation on ethical and practical grounds.