Changes in U.S. Food and Drug Administration (FDA) procedures meant to speed approvals for medications may have resulted in less exacting standards, a new analysis suggests.
Congressional acts that changed the way the FDA evaluates drugs have led to less rigorous evaluations, with drug approvals being based on fewer and/or earlier-stage clinical trials that may not be randomized, controlled, blinded or based on traditional measures of efficacy, experts noted in the article published in JAMA.
For example, the proportion of new drug approvals supported by at least two so-called pivotal trials – the clinical trials the FDA primarily relies on for its approval decisions – decreased from 80.6% in 1995-1997 to 52.8% in 2015-2017.
Those changes may lead to less confidence in the FDA’s approval process, said lead author Jonathan Darrow of Harvard Medical School in Boston and Brigham & Women’s Hospital Division of Pharmacoepidemiology & Pharmacoeconomics.
If drugs approved with less evidence turn out to be problematic it may lead to “an erosion of the ‘FDA approved’ brand,” Darrow said…