HHS Says the FDA's Fast-Track Drug Voucher Program Is Still Running After a Report It Stalled Without Makary

A Trump administration program built to move promising medicines through the Food and Drug Administration in a matter of weeks has gone largely quiet since former Commissioner Marty Makary left the agency in May, Reuters reported Thursday, citing six people familiar with the matter and internal agency documents ^[1]. The Department of Health and Human Services disputes that account and says the effort is still alive ^[1][2].

HHS spokesperson Emily Hilliard told Reuters the pilot is ongoing and that the FDA is studying feedback from a public hearing held in June so it can refine the program's framework ^[1]. Becker's Hospital Review, which relayed the Reuters findings, also noted the department's position that the pilot continues, and neither HHS nor the FDA has announced that the program is over ^[1][2].

What the report found

The program at the center of the dispute is the Commissioner's National Priority Voucher, a pilot the FDA rolled out in June 2025 ^[5]. Makary said at the time that vouchers would go to a select group of products whose makers agreed to make medicines more affordable, bring manufacturing home as a matter of national security, or meet an unmet public health need, and the agency promised a highly expedited review of one to two months, according to an Arnold & Porter advisory published when applications opened ^[5]. The FDA later listed five priorities: answering a U.S. public health crisis, delivering more innovative cures, addressing a large unmet medical need, onshoring drug development and manufacturing, and increasing affordability ^[5].

According to Reuters, no new drug has received a voucher since Makary's departure, and an executive council of political appointees that drove the speedy reviews has gone dormant ^[1]. Twelve of the 22 drugs awarded vouchers have been approved, including five since Makary left, the news agency reported ^[1]. For the nine drugs still in the program, career FDA scientists have resumed overseeing review timelines, two of Reuters' sources said ^[1].

Becker's Hospital Review highlighted one case that shows the slowdown: Merck KGaA's fertility treatment Pergoveris, which received a voucher as part of a drug-pricing agreement with the administration, remains unapproved three months after the FDA accepted its final application ^[2].

Fierce Pharma separately reported that the agency appears to have stopped adding entries to its public database of complete response letters, the letters the FDA sends companies when it declines to approve an application, with nothing new posted in about three months ^[3]. The FDA told the outlet it remains committed to releasing those letters proactively and will keep publishing them with appropriate redactions ^[3].

Why it matters to patients and families

For a family waiting on a new treatment, speed at the FDA is not an abstraction. The voucher pilot reflected a common-sense idea that many conservatives share: once the science on a safe, effective medicine is in, Washington should not make sick Americans wait months longer than necessary, and the government can use its leverage to reward companies that build plants here and lower prices at home ^[5]. Among the products cleared under the program, BioSpace has reported, are Eli Lilly's obesity pill Foundayo and Regeneron's gene therapy for hearing loss, Otarmeni ^[4].

The program also drew pointed criticism. Several patient, industry and trade groups asked the FDA to pause it, citing worries about transparency and the risk of political influence over which drugs move to the front of the line, BioSpace reported ^[4]. At the June hearing, former FDA official Peter Lurie argued that the pilot handed review decisions to political appointees, risked consumer safety by compressing timelines and lacked transparency, according to Reuters ^[1]. HHS told BioSpace that initiatives Makary started, including the voucher pilot, would carry on after he left ^[4].

Related Beating Breast Cancer Shouldn't Cost a Woman Her Bones: What Survivors Should Ask Their Doctors

Both sides of that argument can hold some truth. A reform that gets safe cures to patients faster is worth defending, and it will be easier to defend if its rules are written down, applied evenly and kept clear of favoritism, so that a mother whose child has a rare disease never has to wonder whether lobbying outran the science.

What comes next

The pilot's future may rest with the agency's next leader. The Senate Health, Education, Labor and Pensions Committee is scheduled to vote Nov. 18 on Dr. Heidi Overton, President Trump's nominee for FDA commissioner, Medical Daily reported ^[6]. Her path is uncertain: Republicans hold a one-vote edge on the panel, and Chairman Bill Cassidy of Louisiana has not said whether he will vote to advance her, having raised serious concerns about her role in the administration's childhood vaccine order ^[6]. Sen. Lisa Murkowski of Alaska also joined Democrats in pressing Overton about the abortion pill mifepristone, the outlet reported ^[6].

A committee vote would not settle the nomination; if the panel advances her, Overton would still need a vote of the full Senate ^[6]. Until the agency has a confirmed commissioner, the nine drugs still holding vouchers remain in the hands of career reviewers, and companies hoping for the fast lane are left waiting for a clear answer from the FDA ^[1].