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.
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We live in Friendship, Wisconsin, and Boller & Vaughan came to our doorstep to discuss our mother’s wrongful death claim on a Saturday morning. Not only were we pleased with the large recovery, we were so thankful to have lawyers who were willing to explain to us every twist and turn along the way. It is great to know there is a law firm that will fight for the rights of elderly people all over Wisconsin.
Mr. Boller and Ms. Vaughan were incredible in working on my case and my daughter’s case. I was out of work and in the hospital with a new baby. Mr. Boller and Ms. Vaughan protected our rights and it was a pleasure to work with them. I hope never to be in another motor vehicle accident, however, if I am and I am injured, I will contact Boller & Vaughan immediately.
I was referred to Michelle through a friend. I have never had a better experience. It took a little over a year to get my settlement but the staff there stayed in constant contact and kept me in the loop. Oh, and Michelle actually got me MORE money than we discussed. I will refer anyone to this firm. Words cannot do justice the thanks that I have for Michelle and her staff (Mary especially) thank you guys so much!
After my husband died as a result of a motor vehicle accident, Boller & Vaughan spent countless hours talking with me, meeting with me in person, and making sure that I was okay. The drunk driver who hit us did not have any insurance, and we had to make a claim through our own insurance. Boller & Vaughan was fantastic at explaining the law to me and the handling of our claims.
After my son was injured in a daycare setting, Ms. Vaughan took the time to thoroughly investigate our case and my son’s injuries. Michele was approachable and had answers to our questions. Talking with her helped to relieve many of our anxieties.