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:
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.
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.
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.
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.
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.
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