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FDA is Issuing More Postmarketing Requirements, but Challenges with Oversight Persist


FDA approves new drugs for sale in the United States through the new drug application (NDA) review process. FDA requires all new drugs to undergo clinical testing to demonstrate their safety and efficacy prior to approval. However, premarket clinical trials may not always identify or fully characterize risks. Postmarketing research can provide additional information about the risks, benefits, and optimal use of an approved drug. In 2006, the Office of Inspector General (OIG) found that FDA could not readily identify whether or how timely postmarketing studies were progressing toward completion, and that FDA lacked an effective monitoring system for postmarketing studies. Since then, the Food and Drug Administration Amendments Act (FDAAA) expanded FDA's authority to require postmarketing studies and to take enforcement action when sponsors are out of compliance. This study follows up on OIG's previous work in light of FDA's expanded authority.


We analyzed data from FDA's Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) for all prescription drug PMRs initiated in FY 2008 through 2014. We reviewed all FY 2014 Annual Status Reports (ASRs) and FDA ASR review documents for PMRs initiated in our review period. We also reviewed all noncompliance communication from FDA to sponsors of PMRs from FY 2008-FY 2014. Finally, we interviewed FDA staff.


FDA used its FDAAA authority to issue half of all PMRs in FY 2008 through FY 2014, and required multiple types of studies and clinical trials to fulfill PMRs. It issued PMRs for both supplemental applications and NDAs, and the majority of PMRs were related to NDAs. FDA issued PMRs more often for NDAs reviewed through expedited programs than for non-expedited NDAs. Sponsors are completing most PMRs according to schedule, but a few PMRs are delayed. For about half of all PMRs fulfilled in FY 2014, FDA required sponsors to make labeling changes and/or take other actions to ensure the safety of their drugs. However, FDA continues to have problems with its data management system and work processes, which hinder its ability to track PMRs.


FDA should:

  1. Provide a standardized form for ASRs, ensure that they are complete, and require sponsors to submit them electronically. Standardized forms and electronic submission would provide FDA staff with comparable information across ASRs and eliminate the need for manual data entry, enhancing FDA's ability to track PMRs.
  2. Build capacity in DARRTS to support PMR oversight. Automated reports could improve FDA staff's ability to identify pending ASR due dates, PMR statuses that are overdue for updates, or missing and late ASRs.
  3. Determine the reasons why some PMRs have been delayed for years, and take action as appropriate.

FDA implemented our recommendation to determine the reasons some PMRs have been delayed and concurred with our other two recommendations.