FDA approvals relying on weaker evidence, study finds

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While the FDA has gotten faster at approving new drugs, it is relying on weaker evidence in granting those approvals, according to a study published Jan. 14 in JAMA. 

Researchers analyzed FDA drug approvals, changes in laws and regulations and the rise in drug industry funding of the FDA's reviews from 1983 until 2018.

Almost half of recent drug approvals were based on just one pivotal clinical trial instead of the two or more that used to be standard, NPR reported. There has also been a greater reliance on surrogate measures in clinical trials, which are stand-ins for presumed patient benefits. 

The researchers found that in 2018, the median review time for standard drug applications was 10.1 months, compared to 2.8 years from 1986 to 1992. 

The result is that there are more drugs on the market but less proof that they're safe and effective, according to NPR

Patients and physicians "should not expect that new drugs will be dramatically better than older ones," Jonathon Darrow, PhD, the study's lead author and a lawyer at Harvard Medical School, told NPR

Drugmakers began paying the FDA to fund the review process in the 1980s after AIDS activists protested the agency's slow approval pace. In 2018, drug industry fees made up about 80 percent of the money spent on FDA employee salary for drug reviews, the study found. 

"There is some concern about the incentives that this created within the FDA," Dr. Darrow told NPR. "And whether it has created a culture in the FDA where the primary client is no longer viewed as the patient, but as the industry."

Read the full article here.

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