The U.S. Food and Drug Administration (FDA) has reportedly halted its controversial fast-track drug review pilot program amid internal turmoil and a prolonged leadership vacuum.
The program was launched in June 2025 to shorten the review time from approximately 10-12 months to 1-2 months following a sponsor's final drug application submission.
Citing six sources and internal records, Reuters on Thursday reported that the Commissioner's National Priority Voucher program has stalled since former agency head Marty Makary exited in May.
Regulators once promoted the initiative as an aggressive reform for U.S. pharmaceutical oversight, yet infighting has left the effort adrift.
In November 2025, U.S. Rep. Frank Pallone and Sen. Bernie Sanders highlighted that the initiative was opaque. It risks favoritism, rushed reviews and threats to public confidence.
In a letter addressed to Makary, Pallone and Sanders warned that the vouchers create a lucrative incentive that may advantage firms aligned with the Trump administration.
Leadership Vacuum Fuels Regulatory Stagnation
The agency has operated without a permanent chief for months, with Kyle Diamantas serving as acting commissioner.
Meanwhile, President Donald Trump nominated Heidi Overton to lead the agency, and the Senate Health Committee will vote on her nomination on Nov. 18.
Although the voucher program accelerated approvals by at least eight months for several treatments, clearing 12 of 22 selected drugs, including five after May, the FDA has awarded no new vouchers since Makary's departure.
Citing internal documents, Reuters noted that a political appointee council central to driving those rapid reviews has become dormant.
One source told Reuters that FDA leaders informed drugmakers the agency will not advance the initiative, leaving open applications stalled.
However, HHS spokesperson Emily Hilliard insisted the pilot continues as officials evaluate feedback from a June public hearing.
Career Scientists Reclaim Oversight From Political Appointees
During that June forum, former FDA executive Peter Lurie joined medical experts, industry voices and patient advocates in condemning the program.
Critics argued that letting political appointees steer drug decisions compromised transparency and risked consumer safety through rushed timelines.
Records indicate that the dormant council bypassed vetting the two latest voucher drugs approved since May: Merck & Co. Inc. (NYSE: MRK) cholesterol pill Lipfendra and Revolution Medicines Inc. (NASDAQ: RVMD) pancreatic cancer therapy Rasonque.
Regulators cleared Rasonque on a swift timeline typical for cancer therapies by using preexisting oncology review mechanisms.
Two sources confirmed that FDA career scientists have now resumed managing review timelines for the nine drugs still active in the program.
