Makary, Prasad balance vows to speed reviews with industry criticism 

In a JAMA article published Tuesday and a webinar held Wednesday, FDA Commissioner Marty Makary and CBER Director Vinay Prasad outlined initiatives aimed at accelerating drug reviews, increasing competition, and advancing the Trump administration’s “most favored nation” drug pricing policies.

The most consequential new policy may be a commitment to “massively streamlining the burden to develop biosimilar compounds.” Streamlining regulatory requirements for biosimilars could lower development costs, reduce healthcare spending on legacy biologics, and create incentives for biopharmaceutical innovation...