Public Misinformed About FDA Drug-Approval Process

William E. Johnson
February 10, 2014


         Many patients and physicians assume that the safety and effectiveness of newly approved drugs is well understood; however, the strength of the evidence necessary in drug approval by the US Food and Drug Administration (FDA) has not been evaluated. That is, until now. A new paper published by Nicholas Downing of Yale University found that there is a wide variation in the quality of evidence considered by the FDA in approving new drugs. This alarming new study raises substantial questions about what is exactly required of a new drug entering the market. 

No Tangible Benefit Required

        Between 2005 and 2011, nearly half of all new drug formulations in the United States were approved without pharmaceutical companies having to demonstrate a single tangible benefit. In other words, new drugs do not have to have a positive impact on a patient, or any utility whatsoever, to be approved. While patients and physicians rely on the FDA to serve as a proper gatekeeper for pharmaceutical companies attempting to enter the market, it appears as though their trust is misplaced.

Misplaced Trust in Pharmaceutical Companies

         A study conducted in 2011 found that the role of the FDA’s drug-approval process is severely misunderstood. 39% percent of those surveyed mistakenly believed that the FDA approves only “extremely effective” drugs; 25% mistakenly believed that the FDA approves only drugs without serious side effects. Rather than conducting a thorough investigation into the benefits and risks of new drugs that enter the market, it appears as though the FDA’s gate keeping standards are completely randomized.

Pharmaceutical Liability

        Pharmaceuticals are supposed to heal, comfort and protect. Unfortunately, not all work as they’re supposed to and some can cause severe problems, even death. Pharmaceutical companies know how to fight a court case, and they have the resources to litigate and delay a valid claim for years. That's why it is essential that those who have been harmed by their negligence choose their lawyers wisely. If you or a loved one have had a problem with a defective drug, contact William E. Johnson today for a free consultation and case evaluation.