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Drug Safety: FDA Has Begun Efforts to Enhance Postmarket Safety, but Additional Actions Are Needed

GAO-10-68 Published: Nov 09, 2009. Publicly Released: Dec 09, 2009.
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There have been long-standing concerns regarding the Food and Drug Administration's (FDA) oversight of postmarket drug safety. In 2006, GAO reported that FDA had not clearly defined the roles of two offices involved in making decisions about postmarket safety--the Office of New Drugs (OND) and the Office of Surveillance and Epidemiology (OSE). GAO and others reported additional concerns such as limitations in the data FDA relies on to identify postmarket drug safety issues and the systems it uses to track such issues. At that time, GAO made recommendations, including that FDA improve the independence of its program for resolving scientific disputes related to postmarket drug safety. In 2007, legislation further expanded FDA's postmarket responsibilities. This report examines the steps that FDA is taking to (1) enhance its processes for making decisions about the safety of marketed drugs, (2) improve access to data that help the agency identify drug safety issues, and (3) build its capacity to fulfill its postmarket drug safety workload. GAO reviewed FDA policies and planning documents, and interviewed FDA officials.


Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration To address weaknesses in FDA's oversight of postmarket drug safety, the Commissioner of FDA should develop a comprehensive plan for transferring the additional regulatory authorities from OND to OSE that includes time frames for the transfer and steps to ensure resources are properly aligned to allow OSE to assume these responsibilities.
Closed – Not Implemented
FDA agreed that developing a comprehensive plan to prepare the Office of Surveillance and Epidemiology (OSE) for the transfer of additional regulatory authorities from the Office of New Drugs (OND) was desirable. However, in 2012, FDA said it believes that our recommendation is no longer necessary and should be considered closed. FDA said that it has made significant progress toward the goal of OSE assuming more responsibility in the oversight of postmarketing safety, but that our recommendation has been taken over by events and is no longer warranted. FDA cited various initiatives, revised procedures, and associated guidance documents as the basis for its justification. FDA stated that its approach has involved activities in both the preapproval and postapproval phases of the product lifecycle. For example, OSE's Division of Medication Error Prevention and Analysis was given signatory authority for all decisional letters regarding review of proposed proprietary names submitted during the preapproval phase and this process has been formalized in the agency's policies and procedures. The roles and responsibilities of the offices involved in the review and management of significant postmarketing safety issues are now specified. In addition, new policies and processes to appropriately address these issues (such as classification and prioritization of significant safety issues and expected timelines for review and decision making) have been established. FDA has clarified that OSE also has responsibility for coordination and management of postmarketing safety issues. OSE has also worked with the OND and external epidemiology research investigators to complete in-depth safety studies, the results of which inform FDA's regulatory decision-making process and enhance drug safety assessments. These and other efforts currently ongoing have greatly increased OSE?s role in the management of postmarketing safety issues. For example, according to FDA, OSE plays an integral role in developing and clearing drug safety communications to the public, determining the priority for significant safety issues based on input from multi-disciplinary teams, and leading the implementation of the new capabilities it has developed through FDA's new Sentinel System--an active surveillance system for monitoring drugs, using electronic data from healthcare information holders on FDA regulated products. In addition to these efforts, FDA has undertaken other efforts to promote postmarket safety such as implementing its new FDA Adverse Event Reporting System which will eventually replace its current system.

Full Report

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