Pharma Reform

The Pharma Reform hub tracks the contested boundary between speed and evidence in U.S. drug regulation: accelerated approval, surrogate endpoints, post-marketing confirmation requirements, direct-to-consumer advertising, pharmacy benefit manager economics, and the transparency of clinical-trial data. The MAHA coalition’s position on pharma is more nuanced than its critics often allow. Some voices argue for tighter approval standards. Others argue for faster access to specific therapies where conventional medicine has stalled. The HHS leadership has signaled both at different moments.

The current policy landscape is shaped by three concurrent threads. FDA Commissioner Marty Makary has launched a National Priority Review Program and emphasized AI-assisted approval timelines. The Center for Biologics Evaluation and Research (CBER), under Vinay Prasad until late April 2026, became the most public test case for tighter evidence standards on rare-disease therapies before Prasad returned to UCSF, leaving Katherine Szarama as acting director. The Senate Finance Committee held bipartisan hearings on pharmacy benefit manager transparency in May 2025, and a Crapo–Wyden bill on PBM accountability was introduced in December 2025.

From the roster, Vinay Prasad is the most-published movement voice on FDA pathway reform; his academic work on accelerated approval and surrogate endpoints is the source of much of the coalition’s regulatory rhetoric. Marty Makary sits at the operational center as FDA Commissioner. Robert F. Kennedy Jr. has used HHS leadership to push pharma transparency posture in public statements and budget testimony.