STAT+: Pharmalot: We’re reading about a lack of FDA adcomms, FDA loosening biosimilar rules, and more

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Source: STAT News

Original: https://www.statnews.com/pharmalot/2026/03/09/fda-biosimilars-prasad-novo-hims-w...

Published: Mon, 09 Mar 2026 13:11:56 +0000

Concerns are growing that the FDA is avoiding advisory committees (adcomms) that allow agency leaders, drugmakers, patients, and doctors to voice opinions publicly[1][2][4]. The percentage of FDA approved drugs with an advisory committee recommendation fell from 55% in 2010 to 6% in 2021[1]. In 2025, the FDA held only 7 advisory committees, instead of an average of 12 in 2021–2024, and ruled against committee recommendations in 3 cases, a 43% dissent[2]. From 2024 to 2025, total adcoms dropped by 65% ​​and there was a 9-month hiatus in drug meetings[4]. The FDA plans the first advisory committee in 2026 on April 30 to review two oncology applications from AstraZeneca[4]. Some FDA officials criticize the advisory committees as costly and slow[2][4]. Conflicts of interest persist especially among public speakers, where they are associated with positive testimony with a probability of 3.0 to 6.1 times higher[6].