Drug Safety: Improvement Needed in FDA's Postmarket Decision-making and Oversight Process
GAO-06-402
Published: Mar 31, 2006. Publicly Released: Apr 24, 2006.
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Highlights
In 2004, several high-profile drug safety cases raised concerns about the Food and Drug Administration's (FDA) ability to manage postmarket drug safety issues. In some cases there have been disagreements within FDA about how to address safety issues. In this report GAO (1) describes FDA's organizational structure and process for postmarket drug safety decision making, (2) assesses the effectiveness of FDA's postmarket drug safety decision-making process, and (3) assesses the steps FDA is taking to improve postmarket drug safety decision making. GAO conducted an organizational review and case studies of four drugs with safety issues: Arava, Baycol, Bextra, and Propulsid.
Recommendations
Matter for Congressional Consideration
| Matter | Status | Comments |
|---|---|---|
| To improve the decision-making process for postmarket drug safety, the Congress may wish to consider expanding FDA's authority to require drug sponsors to conduct postmarket studies, such as clinical trials or observational studies, as needed, to collect additional data on drug safety concerns. |
Closed – Implemented
|
Consistent with the matter for Congressional consideration that we put forth, Congress expanded FDA's authority through the Food and Drug Administration Amendments Act of 2007, which the President signed into law on September 27, 2007. Among other provisions, this law gives FDA authority to require drug sponsors to conduct postmarket studies to collect additional data on drug safety concerns. |
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Food and Drug Administration | To improve the postmarket drug safety decision-making process, the Commissioner of FDA should establish a mechanism for systematically tracking ODS's recommendations and subsequent safety actions. |
Closed – Implemented
In September 2007, FDA indicated that a new tracking system to systematically track post-market drug safety issues is being developed as a part of the Document Archiving, Reporting, and Regulatory Tracking System. Training of employees on this post-market drug safety system is currently underway. In January 2007, FDA began incorporating a safety module within the Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) to track the agency's response to significant safety issues identified with the use of marketed drugs. For every significant safety issue, the agency creates a (tracked safety issue (TSI) in DARRTS. In June 2009, the agency published a manual of policies and procedures for tracking significant postmarket safety issues related to drugs in the DARRTS system.
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| Food and Drug Administration | To improve the postmarket drug safety decision-making process, the Commissioner of FDA should, with input from the Drug Safety Oversight Board and the Process Improvement Teams, revise and implement the draft policy on major postmarket drug safety decisions. |
Closed – Not Implemented
In 2009, FDA stated they no longer plan to implement a draft policy on post-market drug safety decision-making. An FDA official stated that the post-market drug safety decision-making process has changed and as a result, the process described in its draft policy is no longer relevant. As a result, the agency does not feel it is necessary to issue a separate post-market drug safety decision-making policy.
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| Food and Drug Administration | To improve the postmarket drug safety decision-making process, the Commissioner of FDA should improve the Center for Drug Evaluation and Research's dispute resolution process by revising the pilot program to increase its independence. |
Closed – Implemented
In September 2007, FDA indicated that a Manual of Policies and Procedures entitled "Documenting Differing Professional Opinions and Dispute Resolution - Pilot Program" is in draft form. It includes a pilot procedure for CDER staff to express differing professional opinions concerning regulatory actions or policy decisions with significant public health impacts in instances when the normal procedures for resolving disputes are not sufficient. This draft manual is currently under internal review.In 2009, an agency official stated the Center for Drug Evaluation and Research is in the process of revising the Differing Professional Opinions policy, but they have not set a date yet for completing the revision. CDER is making a few changes to its policy, but CDER stated the planned changes do not address GAO's recommendation to increase the program's independence. 2012 FDA information indicates that FDA policy documents have implemented this policy.
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| Food and Drug Administration | To improve the postmarket drug safety decision-making process, the Commissioner of FDA should clarify ODS?s role in FDA's scientific advisory committee meetings involving postmarket drug safety issues. |
Closed – Implemented
In September 2007, FDA reported that the Center for Drug Evaluation and Research has implemented a restructuring to facilitate improvements in regulatory and drug development science and how to evaluate and ensure the safety and efficacy of the products FDA regulates. However, FDA response did not include a clarification of ODS's role in FDA's scientific advisory committee meetings involving postmarket drug safety issues. In 2009, FDA stated that instead of developing a policy clarifying ODS's role in meetings, they added language to the manual for agency staff responsible for managing the scientific advisory committees. The manual instructs staff to ask the OND division coordinating an advisory committee meeting on postmarket drug safety issues whether OSE should be involved in the meetings, but doesn't address OSE's role in giving presentations during the meetings. In 2012, FDA clarified that the Office of Surveillance and Epidemiology (new name for ODS) plays an prominent role in setting advisory committe agendas when a safety issue aries.
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Consumer protectionDecision makingDrugsPharmaceutical industryPharmacological researchPrescription drugsProduct safetySafety regulationSafety standardsDrug safety