On May 9, 2017, a new study by Yale researchers in the Journal of the American Medical Association(JAMA) revealed that approximately one-third of new drugs approved by the U.S. Food and Drug Administration (FDA) had safety issues following their approval.
The Yale study looked at 222 drugs and biologics (vaccines, gene therapy, blood and blood components, allergenics, tissues and proteins). Within this group, 32% experienced post-market safety events — two were withdrawn from the market, 61 were given boxed warnings from the FDA and 59 were the subject of FDA safety communications. The researchers found that there were some categories that accounted for much higher rates of post-market safety events, including biologics, psychiatric therapeutics and drugs that underwent the accelerated approval process.
Another Yale study released in April concluded that the FDA approval process is quicker than its European equivalent, the European Medicines Agency (EMA). The study found that the median time for FDA approval between 2011 and 2015 was 306 days compared to 383 days for EMA approvals. The study also noted that the FDA approval process is faster than that in Canada as well.
A 2016 study of the FDA’s fast-track approval process by the U.S. Government Accountability Office (GAO) found that the agency failed to track safety issues and conduct post market studies, adversely impacting the FDA’s regulatory oversight of post market drug safety.
Currently, the FDA has four expedited programs for drug approval: accelerated approval, breakthrough therapy designation, fast track designation and priority review. These four programs are designed to help speed the development and review of new drugs for serious conditions.The GAO study found that from October 2006 to December 2014, one in four drug applications approved by the FDA used at least one expedited program.
Unfortunately for consumers, the GAO study found that the FDA’s data on post market safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult.”
If you have suffered injuries from an unsafe or defective medical product, the experienced product liability legal team at Roberts & Roberts is here to help with compassionate, aggressive representation. Please call 800-248-6000 or contact us for a free consultation.