Office of Inspector General to Focus Enforcement on Five Areas of FDA Regulation

October 18, 2012

The Office of the Inspector General (OIG) recently released its Work Plan for Fiscal Year 2013 (Work Plan) in which the OIG summarizes new and ongoing reviews and activities that it plans to pursue with respect to the Department of Health and Human Services programs and operations during 2013 and beyond.

The OIG has decided to focus its attention on five main areas of the Food and Drug Administration’s (FDA) oversight:

  1. Implementation of Risk Evaluation and Mitigation Strategies Program. The OIG will examine the extent to which the FDA ensures that drug manufacturers comply with the requirements of the Risk Evaluation and Mitigation Strategies (REMS) program. The REMS program is designed to identify risks and benefits of drugs. Drug manufacturers are often required to submit a REMS plan for a drug whose risks may outweigh its benefits. The OIG has targeted the effectiveness of the REMS program as one of its top management and performance challenges, citing the program as critical to drug safety oversight.
  2. Oversight of Wholesale Prescription Drug Distributors. The OIG will assess the adequacy of the FDA’s oversight of wholesale prescription drug distributors, including whether the FDA ensures that states are licensing wholesalers according to applicable state and federal laws.
  3. Complaint Investigation Process. The OIG will determine the adequacy of the FDA’s complaint investigation process, including whether complaints are properly recorded, investigated and categorized to identify potentially significant trends or patterns in reported illnesses or injuries.
  4. Oversight of Investigational New Drug Applications. The OIG will assess the FDA’s timeliness in reviewing and evaluating investigational new drug (IND) applications. IND applications must be submitted to the FDA by sponsors of a new drug product for human use and include all known information about the new drug and describe how the proposed human trials will occur.
  5. 510(k) Process. The OIG will determine the extent to which the FDA documents its decisions to clear devices through the less-stringent Premarket Notification process (510(k)) instead of requiring a more stringent Premarket Approval Application (PMA) to be filed.