Are Makary's priority review vouchers about to be canned?

Reports are emerging that the Commissioner's National Priority Voucher (CNPV) scheme launched by former FDA Commissioner Marty Makary may be heading for the scrap heap.

News agency Reuters has said that it believes that is the case, based on six sources close to the matter and a review of internal FDA documents. If confirmed, it means that the CNPV programme – which has already led to around a dozen product approvals – will be abandoned only around 18 months after it was announced.

First announced in June 2025, the CNPV route can deliver regulatory decisions on marketing applications in a matter of weeks, rather than the usual several months, and is intended to bring important new therapies to patients more quickly, as well as to plug gaps in the domestic supply of essential medicines.

Almost immediately after launch it proved controversial, however, with critics arguing that the selection process is opaque, the programme lacks statutory backing, and undermines usual FDA review process standards.

Meanwhile, there have also been suggestions that political appointees, rather than career regulators, are carrying out the reviews, and that recipients may be selected for political reasons – for example, as a quid pro quo for pricing deals announced by the Trump administration or investments in domestic manufacturing.

In response to those concerns, the FDA held a public hearing in June – shortly after Makary resigned from the agency after 13 months as Commissioner – to get feedback on the CNPV programme, and also published a request for comments in the Federal Register on the eligibility criteria, selection processes, and review procedures.

It also paused issuing the vouchers after Makary's departure, with no drugs cleared under the scheme since then. Reuters reports that "an executive council of political appointees that oversaw drug reviews ​and had a central role in speeding approvals […] has gone dormant."

One source told the news agency that applications are still being accepted by the FDA, but are being left in limbo thereafter. Meanwhile, an HHS spokesperson told Reuters that the pilot "is ongoing and that the FDA is reviewing feedback from a June public hearing on it to refine the ​framework."

There has been speculation that scrutiny of the CNPV programme could become a target for the Democrats, possibly in the context of a probe into Trump's Most-Favoured Nation (MFN) pricing deals, after the party swept to majorities in both the House and Senate in the midterm elections.