Modifications in the U.S. Food and Drug Administration (FDA) procedures meant to speed support for medications could have resulted in less exacting requirements, a new evaluation suggests.
Congressional acts that changed the best way the FDA evaluates drugs have led to less rigorous reviews, with drug licenses being based on fewer or earlier-stage clinical trials that may not be randomized, managed, blinded or based on conventional measures of efficacy, experts noted in the article revealed in JAMA.
For instance, the proportion of recent drug approvals supported by at least two so-referred to as pivotal trials – the clinical trials the FDA primarily depends on for its license decisions – decreased from 80.6% in 1995-1997 to 52.8% in 2015-2017.
Those modifications may result in less confidence in the FDA’s permission course, stated lead author Jonathan Darrow of Harvard Medical School in Boston and Brigham.
If drugs accepted with much less evidence become problematic, it may result in “an erosion of the ‘FDA approved’ model,” Darrow said.
Darrow stated the FDA didn’t always have a rigorous overview course. In 1962, when researchers decided that thalidomide, an anti-nausea drug given to pregnant women, brought about congenital disabilities, the company’s mandate to test the efficacy and safety of recent medicines was stepped up.