According to a recent article in The New England Journal of Medicine, FDA may not be carrying out their full responsibility in regards to post-marketing studies. New legislation has set the grounds for accelerated approval, which means post-marketing studies will become even more crucial. After investigating the safety trial of GlaxoSmithKline’s drug Avandia against Takeda Pharmaceuticals’ Actos, it was determined “usual informed consent” is not sufficient. The safety trial’s origin lies within the accusations of Avandia resulting in increased risk of heart attack and cardiovascular casualties. If Avandia indeed did carry these risks, the article asserts that FDA needed to ensure that Actos was free of similar dangers. Although the trial received some hesitation from FDA, ultimately the inconclusive elements of each drug prevailed and the safety trial continued so long as Avandia remained on the market.

Essentially, NEJM advises FDA to take a closer look at the regulations pertaining to their post-marketing safety studies. Not only do trial participants need to be fully informed on the risks, but the article suggests that FDA needs to follow through in a complete manner on their safety study commitments.

Keeping up to date on post-marketing studies can be time consuming for our clients, and at times, difficult to attain. Need help keeping up to date with regulatory requirements for a post-marketing trial? Contact us at

The NEJM article, authored by three Institute of Medicine members goes into further detail of the safety trial and  outcomes and can be found here.