Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs

The FDA remains committed to ensuring that FDA-approved drugs are safe and effective for Americans. As part of this commitment, we require evidence from premarket clinical trials that the medicine will be both effective and safe for use when prescribed according to its labeling. However, it’s not unusual for the FDA to identify issues that need additional evaluation either at the time of initial approval or later, once the drug has been marketed. These issues are evaluated through the conduct of additional post-marketing studies.

Today we’re announcing our FY 2017 Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. This report provides an update on how we’re doing at holding companies 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. We’re committed to ensuring that PMRs and PMCs are conducted and reported as required, and to providing transparent access to the progress of these studies for the public.

The full statement can be viewed at this link.  

The 2017 report can be downloaded below.