FDA Strengthens Monitoring of Post-Approval Drug Safety
April 24th, 2012 tmccoy
At last, the Food and Drug Administration is giving the same priority to drugs that have been released on the market to ones that are still in the pre-market review phase, and amidst an environment where new drug defects are seemingly found every day, the FDA’s new priorities seem to be working.
A new report released by the agency’s Center for Drug Evaluation and Research states that the new tools used in post-market drug assessment are having a marked impact on increased safety. The crux of the new FDA efforts centers around the distribution of more effective and efficient drug safety information to the public.
Specifically, in 2001, 68 drug safety communications were issued by CDER, up from 39 in 2010. In addition, there has been other evidence of the recent efforts working, including 65 safety-related label alterations over the past 4 years, the implementation of 64 Risk Evaluation and Mitigation Strategies since 2008, and the development of new safety-related programs such as Safety First, Sentinel, and Safe Use.
The Huffington Post reports that the FDA’s focus on post-market drug safety comes after the agency was sharply criticized as being slow to respond to drug side effects, notably Vioxx, a painkiller that Merck & Co Inc pulled five years after approval because of a link to heart attacks and strokes. Congress later gave the FDA more power to oversee drugs after approval, such as ordering companies to change their labels or conduct additional safety trials, and fining them if they fail to do so.
