By Patrick Cooney, for AMRC
FEDERAL AGENCY NEWS
FDA Announces National Priority Voucher Awards
On November 6, 2025, the U.S. Food and Drug Administration (FDA) announced six awardees under the Commissioner’s National Priority Voucher (CNPV) pilot program. This second cohort brings the total number of voucher recipients to 15, as part of the agency’s effort to accelerate the review of products with the potential to address key national priorities.
“National priority vouchers are granted to a select group of products where the company has agreed to increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We are pioneering new ways of bringing these cures and meaningful treatments to the market faster.”
Upon submission of a complete application, national priority voucher holders will receive a decision within months, a drastic reduction of the typical review timeline. The faster timeframe is contingent upon additional requirements from the company, and FDA staff reserve the right to extend the review as needed.
The following products were selected following external applications and internal nominations from FDA review divisions:
- Zongertinib for HER2 lung cancer
- Bedaquiline for drug-resistant tuberculosis in young children
- Dostarlimab for rectal cancer
- Casgevy for sickle cell disease
- Orforglipron for obesity and related health conditions
- Wegovy for obesity and related health conditions
On October 16, 2025, the U.S. Food and Drug Administration (FDA) announced nine voucher recipients.
The following products were selected:
- Pergoveris for infertility
- Teplizumab for Type I diabetes
- Cytisinicline for nicotine vaping addiction
- DB-OTO for deafness
- Cenegermin-bkbj for blindness
- RMC-6236 for pancreatic cancer
- Bitopertin for porphyria
- Ketamine for domestic manufacturing of a critical drug for general anesthesia
- Augmentin XR for domestic manufacturing of a common antibiotic
Trump Administration Announces Deal to Lower Cost of GLP-1 Drugs
On November 6, 2025, the Trump administration announced a deal with Eli Lilly and Novo Nordisk to lower prices on their GLP-1 drugs in exchange for Medicare and Medicaid coverage. The five-year pilot program reportedly under development by CMS would allow Medicaid programs to voluntarily cover GLP-1s for obesity starting in 2026 and Medicare plans the following year.
President Donald Trump announced the GLP-1 agreement Thursday from the Oval Office, unveiling that Medicaid and Medicare prices for Ozempic, Wegovy, Mounjaro, and Zepbound will be set at $245 per month, with qualifying Medicare beneficiaries paying a $50 copay.
By covering GLP-1s under a pilot program, CMS may be able to sidestep formally reinterpreting the Medicare statute’s ban on weight-loss drug coverage. While states must cover most FDA-approved medications, they have discretion over obesity treatments. Currently, only a few state Medicaid programs offer these drugs, and some have cut coverage this year due to budget constraints.
FDA Announces New Guidance on Biosimilar Development
On October 29, 2025, the U.S. Food and Drug Administration (FDA) announced significant action to make it faster and less costly to develop biosimilar medicines. In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing. The agency through a separate initiative also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily.
In its announcement, the FDA stated that the new draft guidance, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies,” is based on the agency’s accrued data and experience since the first biosimilar was approved in 2015. The agency highlighted that despite requiring 1-3 years and costing $24 million on average, comparative efficacy studies generally have low sensitivity compared to many other analytical assessments. The FDA’s new guidance reduces this resource-intensive requirement for developers to conduct comparative human clinical studies, allowing them to rely instead on analytical testing to demonstrate product differences.
The approval pathway for biosimilars was established by Congress in 2010 through the Biologics Price Competition and Innovation Act (BPCIA) to promote competition in markets dominated by high-cost biologics. Since then, the FDA has approved 76 biosimilars that provide Americans additional treatment options for conditions such as cancer, rheumatoid arthritis, diabetes, Crohn’s disease, and osteoporosis.
CAPITOL HILL NEWS
Senate Votes to Reopen the Federal Government
On November 9, 2025, the United States Senate took a pivotal step toward ending the ongoing government shutdown by voting 60-40 to advance a bill, originally passed by the United States House of Representatives, which would fund federal operations and extend appropriations through January 30, 2026. The measure, backed by eight Democratic senators who joined Republicans, also includes three full-year appropriations bills and promises a future vote on restoring premium tax credits under the Affordable Care Act—though the final text does not guarantee the tax credits will be extended now. The vote clears the way for the House to consider the amended funding plan and potentially reopen the government this week—though significant division remains within the Democratic caucus and key issues, including healthcare subsidies, are yet unresolved.
With the resolution of the funding impasse and the reopening of federal operations, many of the bottlenecks hampering clinical research could begin to ease. During the shutdown, agencies such as the National Institutes of Health (NIH) and Food and Drug Administration (FDA) scaled back non-essential operations, resulting in paused enrollments, delayed peer review of grants and submissions, and cancelled or suspended inspections and audits of clinical sites. A reopening means that the staff and functions critical to trial oversight, regulatory review, and site monitoring can resume full capacity, thereby reducing backlog and restoring momentum for new and ongoing study protocols.
