The Government Accountability Report (GAO) recently issued a report that
raises concern about drug safety in the United States. The report found
that there are serious gaps in the U.S. Food and Drug Administration’s
(FDA) procedures for tracking drug safety issues. At the same time, the
report confirmed that the agency is increasingly relying on expedited
procedures to approve new drugs.
Prior to releasing a new drug on the market, pharmaceutical companies must
obtain approval from the FDA, which evaluates a drug application to determine
whether the new drug is safe and effective for its intended use. The FDA
has four expedited programs to facilitate and expedite the development
and review of new drugs that satisfy an unmet need. While these fast-track
procedures can allow patients to receive medications more quickly, it
is imperative that the FDA keep track of follow-up studies required for
According to the
GAO drug safety report, "FDA's data on post-market safety issues and studies were found
to be incomplete, outdated, to contain inaccuracies, and to be stored
in a manner that made routine, systematic analysis difficult." Specific
issues noted in the report include the FDA’s failure to complete
a timely review of more than half of the 1,400 follow-up studies it had
requested or required between 2008 and fall 2013. The reports could contain
valuable information about potential side-effects and other safety risks
that arose once the drug was administered to a larger group of patients.
“If FDA is shifting more of the safety risk to consumers by allowing
fewer and shorter clinical trials on expedited drugs, adequate tracking
of drug safety issues and review of post market studies are absolutely
vital,” Congresswoman Rosa DeLauro, D-CT, said in a statement. Rep.
DeLauro commissioned the study after the GAO concluded in a prior report
that medical devices approved by the FDA are making it onto the market
without sufficient testing or oversight.
San Diego injury lawyers, we are also concerned that lax FDA oversight could expose patients to
drugs that have not been adequately tested and increase the risk of unanticipated
safety risks once a drug is on the market. We will continue to closely
monitor the situation.
If you or someone you care about has suffered serious harm due to a defective
or dangerous drug, you may be entitled to compensation, including reimbursement
of lost wages and medical bills and damages for pain and suffering. To
discuss your claim, please contact
a San Diego product liability attorney at the Law Offices of Robert Vaage
for a free consultation.