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Around the nation: FDA approves first drug through priority voucher program


FDA has approved the first drug through its Commissioner's National Priority Voucher (CNPV) pilot program, which aims to expedite the review of treatments aligned with public health priorities, affordability, or supply chain resistance, in today's bite-sized hospital and health industry news from the District of Columbia, Indiana, and Maryland. 

  • District of Columbia: Since May, U.S. Department of Agriculture (USDA) has approved waivers for 18 states to ban the purchase of soda, energy drinks, candy, and prepared desserts with food stamps provided by the Supplemental Nutrition Assistance Program (SNAP). Six of these states, including Hawaii, Missouri, North Dakota, South Carolina, Virginia, and Tennessee, were approved last week. The restrictions on SNAP purchases are expected to take effect next year and will impact over 14 million participants in 18 states. Eleven other states may also receive waivers to ban unhealthy food purchases on SNAP. "We all know we're at the point where we must do something to correct the chronic health problems that Americans face," said agriculture secretary Brooke Rollins. According to the New York Times, the decision to restrict certain SNAP purchases is a reversal for the USDA, which has usually denied such requests under both Republican and Democratic administrations, including President Donald Trump's first term. (Qiu, New York Times, 12/11; USDA press release, 12/10)
  • Indiana: Former Pfizer executive Amy Schulman will join Elevance's board as an independent director and serve on the audit and finance committees, effective Jan. 12. Currently, Schulman is a managing partner at Polaris Partners and chair of Alnylam Pharmaceuticals' board. She also teaches leadership and corporate governance at Harvard Business School. Previously, Schulman held several senior executive positions at Pfizer. She originally joined Pfizer in 2008 as its general counsel before becoming president of Pfizer Nutrition. According to Elevance board chair Ramey Peru, Schulman's "insight into the intersection of science, technology, and patient care makes her an exceptional addition as we continue to advance and expand our services." (Pifer, Healthcare Dive, 12/11)
  • Maryland: FDA has approved the first drug through its new CNPV pilot program. The program, launched in June, aims to expedite the review of treatments aligned with public health priorities, affordability, or supply chain resistance. So far, FDA has named 15 voucher recipients, including obesity drugs like Wegovy and orforglipron and gene therapies. The first drug approved through the program was Augmentin XR, an oral antibacterial that is used to treat community-acquired pneumonia and acute bacterial sinusitis. In an announcement about the approval, FDA said USAntibiotics' Augementin XR application "demonstrated clear alignment with the CNPV program's national health priorities by strengthening the U.S. drug supply chain through enhanced domestic manufacturing capacity at a U.S. facility" and would help counter antibiotic shortages. However, Fierce Pharma noted that it's unclear what version of Augmentin XR FDA approved through the new program, since the drug was previously approved under its original manufacturer GSK in 2002 and later in 2022 under USAntibiotics, which currently owns the marketing rights. (Jeffries, Becker's Hospital Review, 12/10; Kansteiner, Fierce Pharma, 12/10)

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