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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. 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.
Subject Terms
Product safety
Prescription drugs
Pharmacological research
Pharmaceutical industry
Drugs
Decision making
Consumer protection
Safety regulation
Safety standards
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