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FDA Report
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.
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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