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Before we head out for the holidays, we're back with some breaking news about a few of BIO's legislative priorities. Happy Holidays and Happy New Year! We'll see you in 2025 (unless there's major breaking news over the break). (566 words, 2 minutes, 49 seconds)
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Congress set to pass PBM reform and extensions of Pediatric PRV Program, PAHPA, Farm Bill
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Congress’ end-of-year spending package includes legislation to increase transparency of pharmacy benefit managers (PBMs) and to extend funding for the Pediatric Priority Review Voucher (PPRV), the Pandemic and All Hazards Preparedness Act (PAHPA), and the Farm Bill.
BIO applauded the healthcare and agriculture provisions in the package, which must pass by Dec. 20 to keep the government open: - PBM legislation included would prevent Medicaid spread pricing, in which PBMs pay pharmacies less than the PBMs receive from health plans
- Part D cost-sharing legislation would eliminate generic drug cost-sharing for the Medicare Part D Low-Income Subsidy (LIS) program.
- The Pediatric PRV, a program to encourage the development of treatments for children with rare diseases, would be extended until September 2029.
- PAHPA, which enables public-private partnerships to address pandemics, bioterrorism, and other public health emergencies, was extended, including key provisions such as the medical countermeasure priority review voucher (MCM PRV) and the viral families strategy.
- The Accelerating Kids' Access to Care Act (H.R. 4758) would prevent delays to the ability of children with complex medical conditions to seek specialty care at out-of-state centers of excellence.
- Another bill to note: passage of H.R. 5397, the Joe Fiandra Access to Home Infusion Act, which would provide Medicare coverage to home infusion drugs that are not self-administered.
- The Farm Bill is a package of legislation authorizing most agriculture programs and policies conducted by the U.S. Department of Agriculture (USDA)—including programs with a big impact on the biotech industry. It was extended for a year. BIO will continue to advocate for a new five-year Farm Bill.
BIO’s view: “Congress now has a pivotal opportunity to pass reforms and to authorize funding for programs that will make a meaningful difference to advance the health and well-being of the American people,” said BIO President & CEO John F. Crowley. Read more on Bio.News. |
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Avantor Debuts the Bridgewater Innovation Center
| Longstanding BIO partner, Avantor, recently opened a new innovation center in Bridgewater, NJ. The 60,000-square-foot state-of-the-art research and development facility is part of Avantor’s network of 13 research and innovation centers across the globe.
A new laboratory resource for the life science community: The Bridgewater Innovation Center was purpose-designed for collaborative work housing spaces for upstream and downstream process development, dedicated analytical testing labs, and a viral vector laboratory. In addition, the facility has an expanded pilot plant to support scale-up simulations, enabling rapid customization across the entire bioprocessing workflow.
The Bridgewater Innovation Center allows member companies and the biopharma ecosystem to optimize and accelerate biomanufacturing processes at scale; resulting in faster problem solving, streamlined knowledge exchange, and strategic co-innovation.
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What Else to Read This Week
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A report released yesterday by the House Bipartisan Task Force on Artificial Intelligence notes the importance of AI as an emerging biotech tool. The document highlights AI’s potential for “biomedical or pharmaceutical research” and to advance food security in agriculture through “development to enhance efficiency in specialty crops.” It also discusses the issue of “AI, inventorship, and patentability,” noting its importance to biotech.
Another six states joined the National Milk Testing Strategy to screen raw milk for avian flu,according to the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS). Under the National Milk Testing Strategy (NMTS), APHIS is working in partnership with state veterinarians in collecting and testing milk samples for avian flu. As of yesterday, Indiana, Maryland, Montana, New York, Ohio, Vermont, and Washington joined the first six states—California, Colorado, Michigan, Mississippi, Oregon, and Pennsylvania—in participating in the NMTS. “APHIS will continue to work with each of the 48 contiguous states to participate in the strategy until all states are participating and testing under the NMTS,” USDA said.
ICYMI: CMS directs insurers to cover ALS drug. The Centers for Medicare & Medicaid Services (CMS) issued a Dec. 9 directive telling private insurers providing Medicare Advantage plans to cover Biogen’s amyotrophic lateral sclerosis (ALS) drug Qalsody after finding instances of noncoverage. Qalsody received accelerated approval last year, but some insurers had been refusing to cover the drug, incorrectly classifying it as “experimental and investigational,” CMS said. “CMS does not make a distinction” between traditional and accelerated approval. “This is a victory for the entire ALS community. It’s critical that FDA-approved treatments are made accessible rather than being labeled as ‘experimental,’” said ALS Association CEO Calaneet Balas.
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Beltway Report: What's Ahead in Washington
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