Drugs

Changes in Evidence Supporting FDA Approvals: Study

Researchers from Yale School of Medicine and other academic centers and hospitals say that more recent FDA approvals of new drugs and biologics were based on fewer pivotal trials which, when aggregated by indication, had less rigorous designs but longer trial durations. Writing online at JAMA Network Open, the authors say the study results suggest an ongoing need for continued evaluation of therapeutic safety and efficacy after approval.

The researchers looked at 273 new drugs and biologics that were approved by FDA for 339 indications from 1995 to 1997, 2005 to 2007, and 2015 to 2017.

“Potentially contributing to this variability is the increasing number of special regulatory programs available to FDA during the past 30 years, now including Fast Track, Priority Review, Accelerated Approval, and Breakthrough Therapy designation,” the report says. “Many of these programs codify special evidentiary standards acceptable for FDA approval of certain drugs and biologics, such as the use of surrogate endpoints and the acceptability of single trials as the basis of approval, with the goal of promoting earlier market availability of certain therapies, such as those addressing an unmet need or those treating serious or life-threatening conditions.”

The study found that the proportion of approvals supported by the commonly understood standard of at least two pivotal trials declined from 81% to 53% and the proportion of approvals supported by at least one trial using a comparator declined from 96% to 83%.

“Meanwhile,” the authors write, “it has become more rigorous in other ways, with the proportion of indications supported by at least one trial of six months’ duration increasing from 26% to 46%. These findings have implications for patients and clinicians making decisions about whether to use products newly available on the market as well as clarifying the need for continued evaluation of the safety and efficacy of therapeutics after approval.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome