The news: The FDA Commissioner’s National Priority Voucher (CNPV) program launched under former Commissioner Marty Makary to accelerate drug reviews is facing mounting scrutiny under new leadership. Critics raised concerns about transparency and potential safety risks, while drugmakers were among the only supporters at a recent FDA hearing. The FDA is accepting public comments through June 29 and will use the feedback to help determine the program's future.

Zooming out: The FDA’s decision will determine whether drugmakers retain another fast-track pathway, and whether the agency will tighten transparency and safety rules around how vouchers get rewarded.

The pharma industry is pushing to preserve the program, as it compresses drug review timelines from 10 to 12 months down to one to two months. The FDA has awarded 18 CNPVs since June 2025, including for Eli Lilly's weight loss pill Foundayo. At the hearing, Partner Therapeutics cited the six-week review of its rare cancer drug Bizengri as evidence the program can speed access to treatments for patients with unmet needs.

Critics argue the program lacks transparency in its decision-making. According to reporting from STAT, staff reviewers were entirely excluded from the first voucher decision meeting, which was attended only by senior leadership. This lack of open process has raised deeper concerns about political favoritism; several prominent scientists and former FDA officials pointed out that pharmaceutical giants Eli Lilly and Novo Nordisk received vouchers shortly after announcing broader drug-pricing agreements with the Trump administration, per STAT.

They also raise concerns about threats to patient safety. Doctors for America warned the accelerated pathway could increase the risk of post-approval safety issues. And these concerns are not just theoretical: at least one voucher was actively awarded despite explicit objections and safety concerns raised by the FDA's staff, per STAT.

Implications for pharma companies: The biggest risk is that the FDA eliminates or significantly curtails the program, removing a key pathway for getting priority drugs to market more quickly.

However, we think it’s more likely that the program will survive, but in a more structured and predictable way. In this scenario, clearer eligibility criteria and greater transparency around voucher awards would give drugmakers more certainty in regulatory planning and reduce the risk of unexpected FDA decisions.

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