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REPORT HIGHLIGHTS
DRUG SAFETY: Improvement Needed in FDA’s Postmarket Decision-making and
Oversight Process
Two organizationally distinct FDA offices, the Office of New Drugs (OND) and
the Office of Drug Safety (ODS), are involved in postmarket drug safety
activities. OND, which holds responsibility for approving drugs, is involved
in safety activities throughout the life cycle of a drug, and it has the
decision-making responsibility to take regulatory actions concerning the
postmarket safety of drugs. OND works closely with ODS to help it make
postmarket decisions. ODS, with a primary focus on postmarket safety, serves
primarily as a consultant to OND and does not have independent
decision-making responsibility. ODS has been reorganized several times over
the years. There has been high turnover of ODS directors in the past 10
years, with eight different directors of the office and its predecessors. In
the four drug case studies GAO examined, GAO observed that the postmarket
safety decision-making process was complex and iterative. |
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FDA lacks clear and effective processes for making decisions about, and
providing management oversight of, postmarket safety issues. The process has
been limited by a lack of clarity about how decisions are made and about
organizational roles, insufficient oversight by management, and data
constraints. GAO observed that there is a lack of criteria for determining what
safety actions to take and when to take them. Certain parts of ODS’s role in the
process are unclear, including ODS’s participation in FDA’s scientific advisory
committee meetings organized by OND. Insufficient communication between ODS and
OND has been an ongoing concern and has hindered the decision-making process.
ODS does not track information about ongoing postmarket safety issues, including
the recommendations that ODS staff make for safety actions. FDA faces data
constraints in making postmarket safety decisions. There are weaknesses in the
different types of data available to FDA, and FDA lacks authority to require
certain studies and has resource limitations for obtaining data.
Some of FDA’s initiatives, such as the establishment of a Drug Safety Oversight
Board, a draft policy on major postmarket decision making, and the
identification of new data sources, may improve the postmarket safety
decision-making process, but will not address all gaps. FDA’s newly created Drug
Safety Oversight Board may help provide oversight of important, high-level
safety decisions, but it does not address the lack of systematic tracking of
ongoing safety issues. Other initiatives, such as FDA’s draft policy on major
postmarket decisions and regular meetings between OND divisions and ODS, may
help improve the clarity and effectiveness of the process, but they are not
fully implemented. FDA has not clarified ODS’s role in certain scientific
advisory committee meetings. FDA’s dispute resolution processes for
disagreements about postmarket safety decisions have not been used. FDA is
taking steps to identify additional data sources, but data constraints remain.
Why GAO Did This Study
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.
What GAO Recommends
To improve the decision-making process for postmarket drug safety, GAO suggests
that the Congress consider expanding FDA’s authority to require drug sponsors to
conduct postmarket studies when needed. GAO also recommends that FDA
systematically track postmarket drug safety issues, revise and implement its
draft policy on major postmarket safety decisions, improve the dispute
resolution process, and clarify ODS’s role in scientific advisory committees. In
its comments on a draft of this report, FDA stated that GAO’s conclusions were
reasonable. FDA did not comment on GAO’s recommendations.
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