"Makary launched initiatives to streamline some of the FDA's regulatory functions - including real-time clinical trials and the awarding of vouchers to speed up reviews of some treatments deemed in step with the administration's priorities. He also took steps to reduce animal testing."
"For example, President Trump had to pressure him to approve flavored vapes after Makary initially resisted, The Wall Street Journal reported."
"Anti-abortion groups called for Makary to be fired, frustrated that he didn't roll back liberalized rules for obtaining the widely used abortion pill mifepristone and reinstate in-person dispensing requirements. Indeed, under his tenure the FDA approved a generic version."
"Under Makary's leadership, the FDA also drew controversy for rejecting certain rare disease drugs. Biologics division chief Vinay Prasad, who has also since left the agency, was at the center of those decisions as well."
Marty Makary’s departure from the FDA followed repeated controversies involving abortion pills, flavored vapes, vaccines, and rare disease drugs. Internal criticism focused on his limited alignment with some President Trump priorities, while health care investors complained about regulatory unpredictability that rejected some promising drugs. Makary also pursued initiatives to streamline FDA regulation, including real-time clinical trials, vouchers to speed reviews for treatments aligned with administration priorities, and steps to reduce animal testing. Despite these efforts, he faced pressure to approve flavored vapes after initial resistance. Anti-abortion groups sought his removal for not reversing mifepristone rules and for allowing a generic version. The FDA also faced controversy for rejecting certain rare disease drugs, with biologics division chief Vinay Prasad involved in related decisions.
Read at Axios
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