GAO Releases New Report on FDA’s Failure to Safely Monitor Medications

The U.S. Government Accountability Office (GAO) has issued a new report finding that the U.S. Food & Drug Administration’s (FDA) process for tracking drug safety issues still contains serious gaps. Instead, the FDA continues to use more and more expedited procedures to approve new drugs.

All new drugs must apply for FDA approval in order to ensure that they are safe and effective as they are intended to be used. In some cases, however, the FDA can “fast-track” a drug where there is a clear need for the drug. Ideally, the FDA should conduct follow-up studies on the drug in order to determine any side-effects and potential safety risks by using the medication.

Unfortunately, the new GAO report finds that the FDA has been lax in reviewing follow-up studies in a large number of expedited drug cases. Some of the studies were incomplete, contained inaccuracies, and were organized in a way that made routine analysis difficult, at best. As a result, the report raises concerns about whether drugs are undergoing significant research and clinical trials before being placed on the market.

We share the concerns of the GAO with respect to the unknown hazards of new medications that could cause severe injuries and even death to patients who are prescribed the drugs. We also recognize that if you or a loved one are injured by a new medication, it may be due to a lack of oversight on the part of the FDA, among others.

Individuals who suffer injuries due to defective or dangerous drugs may have valid legal claims for damages stemming from their injuries. At Boller & Vaughan, we know how to stand up for the rights of those who have been injured at the hands of others. Call us today at (608) 268-0268, schedule an appointment with one of our Wisconsin personal injury attorneys, and learn how we can assist you.