An 'erosion' of standards at the FDA over 40 years has led to the quick approval of new drugs, Harvard Medical researchers allege. The FDA said the statistics considered by the researchers 'could result in inaccurate conclusions.'
The FDA is approving new drugs more quickly than ever, and using less-stringent standards to determine whether those drugs actually work, according to a new study published in the peer-reviewed JAMA, the journal of the American Medical Association.
The researchers examined FDA databases of approved new drugs and several FDA drug-approval programs, some of which were designed to get life-saving drugs to patients faster. They also looked at the issue of so-called user fees, which drug manufacturers pay to help fund FDA activities. The FDA is conducting a detailed review of the JAMA article and its recommendations, he added, and plans to issue a more comprehensive response after analyzing the publication.
Meanwhile, the median review time for standard and priority drug applications dwindled: It was 2.8 years in 1986-1992, 1.5 years in 1993-2005 and 1.2 years in the 2006 to 2017 period. In 2018, that review time sat at just 10 months for standard applications and less than eight months for priority applications.
“These regulatory innovations have not clearly led to an increase in new drug approvals or to reduced total development times,” they wrote.
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