FDA Reviews Drug Program, Launches Mifepristone Study
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- U.S. Food and Drug Administration held a listening session at its White Oak Campus with 17 speakers from patient groups, drug companies, and academic organizations to discuss the speedy drug review program introduced by former commissioner Marty Makary.
- U.S. Food and Drug Administration received mixed feedback, with some participants praising the program’s approvals, but most urging the agency to pause it and revert to standard regulatory processes that include public input.
- U.S. Food and Drug Administration launched a six‑month safety study of the abortion medication mifepristone, a step that could enable the Trump administration to restrict its distribution and use.
- Anti‑abortion groups called the safety study a victory after months of pressure on the administration.
Why it matters: Pausing the fast‑track program will delay new drug approvals, hurting patients awaiting treatments and slowing pharma revenue, while the mifepristone safety study gives the Trump administration a regulatory foothold to curb abortion‑pill access, affecting providers and patients.
