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# Pazdur, Others Concerned About Voucher Program Integrity
- URL: https://www.fdaweb.com/pazdur-others-concerned-about-voucher-program-integrity/
- Published: 2026-01-16T12:00:00.000Z
- Updated: 2026-09-14T15:30:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160504

Former FDA oncology drug leader **Richard Pazdur** said concerns surrounding a controversial fast-track drug review initiative under commissioner Marty Makary reflect deeper problems inside the agency, including politicization of regulatory decisions, diminished transparency, and disregard for scientific staff — issues that ultimately led to his departure from the agency late last month. In an interview by Reuters, Pazdur said unease among drugmakers over the commissioner’s National Priority Voucher Program has become a proxy for broader worries about how the agency is operating under Makary’s leadership. The program allows the FDA to complete reviews of select drugs in as little as one to two months, far faster than the agency’s traditional timelines.

“There are companies that came up to me at conferences and said they are not going ahead with it,” Pazdur told Reuters, referring to the voucher program. Some companies asked whether opting out could be viewed negatively by the agency, he added, prompting him to reassure them that deserving products would still receive expedited consideration through existing pathways.

The voucher program, unveiled in June, gives Makary authority to grant rapid reviews for medicines deemed critical to public health or national security, or those manufactured domestically or offered at lower prices. The initiative has been promoted by the Trump administration as a means to accelerate patient access to important therapies.

However, more than half a dozen pharmaceutical companies participating in the program are being counterbalanced by others that are hesitant, citing potential legal and regulatory risks, according to Reuters. Industry executives and advisers interviewed this week at the J.P. Morgan Healthcare Conference said a two-month review window could undermine the scientific rigor traditionally associated with FDA approvals.

Executives expressed concern that abbreviated reviews could weaken the credibility of FDA decisions and expose manufacturers to increased liability if safety issues emerge after approval. One Washington-based attorney specializing in FDA regulatory law warned that rushed label determinations could make it easier for plaintiffs to argue that warnings were inadequate, shifting more legal responsibility onto drugmakers.

A senior executive at one large pharmaceutical company said their firm would not pursue a priority voucher, citing doubts about whether the program would survive beyond the current administration and fears that approvals could later be challenged in court.

The Department of Health and Human Services defended the initiative, saying FDA decisions remain grounded in evidence-based science and that the agency continues to operate as a stable, science-driven regulator.

To date, the FDA has issued vouchers for 18 drugs, including a highly anticipated weight-loss pill from Eli Lilly, as well as products from Merck, GSK, Johnson & Johnson and Regeneron. Only one product, a generic antibiotic previously marketed in the U.S., has so far been approved under the program.

Despite the promise of one-to-two-month decisions, some reviews are already extending to four months or longer ([see story](https://www.fdaweb.com/2-voucher-program-drug-reviews-delayed-reuters/)), and several candidates have been delayed after FDA scientists flagged safety and efficacy concerns, including a patient death associated with one investigational drug.

Supporters of the initiative argue it prioritizes the most impactful medicines without compromising standards. Eli Lilly research chief **Dan Skovronsky** said the program moves high-priority drugs to the front of the review queue rather than cutting corners, while emphasizing that companies still want the FDA to remain firmly science-driven.

Meanwhile, senior FDA officials are still debating who has the legal authority to approve drugs cleared through the voucher pathway, according to reporting from the [Associated Press](https://apnews.com/article/fda-makary-voucher-drug-reviews-a3f550f229dc4ed196da9d1a2bc86bc3?utm%5Fsource=st.%20albert%20gazette&utm%5Fcampaign=st.%20albert%20gazette%3A%20outbound&utm%5Fmedium=referral). Traditionally, approvals are issued by career review scientists and their immediate supervisors, not by political appointees or top agency leadership. And reviewers say they have received little guidance on how the program operates. In at least one case, staff working on a closely watched anti-obesity pill were told they could skip established regulatory steps to meet aggressive deadlines set by senior officials.

Legal concerns reportedly prompted former CDEER director **George Tidmarsh** to refuse to sign off on approvals under the program before his resignation in November. His successor in line, principal deputy commissioner **Sara Brenner**, also declined the role after reviewing potential legal risks. The responsibility has since fallen to **Mallika Mundkur**, who reports to CBER director **Vinay Prasad**.

“The concept of doing a review in one to two months just does not have scientific precedent,” Harvard Medical School professor **Aaron Kesselheim** told the AP. “FDA cannot do the same detailed review that it does of a regular application in one to two months, and it doesn’t have the resources to do it.”

Not all FDA watchers see the program as unlawful. **Dan Troy**, FDA’s chief counsel during the George W. Bush administration, said federal law grants the commissioner broad authority to reorganize reviews. Still, he warned the initiative may be fleeting because it lacks formal grounding. “If you live by the press release then you die by the press release,” Troy told the AP, noting a future administration could quickly dismantle it.

“They are fundamentally changing the application of the standards, but the underlying law remains what it is,” Kesselheim said. “The hope is that one day we will return to scientifically and legally sound principles.”