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New GAO Report Highlights Flaws in FDA Drug Oversight

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 the drugs.

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to the GAO drug safety report, "FDA's data on post-market safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult." An example of the specific issues the report noted were the FDA's failings to review more than half of follow-up studies that took place from 2008-2013. These reports could contain important information about side-effects.

“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.

As 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.