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This couldn't wait for Monday. We have an exclusive interview with Sen. Todd Young on biosecurity, plus good news about Centers for Medicare and Medicaid Services (CMS) rules governing drug rebates in Medicaid. (668 words, 3 minutes, 20 seconds)
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Exclusive: Bio.News interview with Sen. Todd Young on biosecurity |
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Sen. Todd Young (R-IN) was recently named Chair of the National Security Commission on Emerging Biotechnology (NSCEB), established by Congress to recommend policy on biotech and national security. Highlights of our Bio.News exclusive are below.
Why it matters: “This is the Age of Biology and if the United States is going to lead in this age with our values and our market, we must lay the groundwork with policies that bolster innovation, foster industry growth, and support the safety and security of Americans.”
House passage of the BIOSECURE Act: “I support the bill’s goal of preventing American taxpayer dollars from going to biotechnology companies that are owned by and answerable to the Chinese Communist Party or other foreign adversaries.”
The NSCEB’s first year: “Outstanding,” he said. “More than a few of our early policy ideas have been incorporated in proposed legislation.”
The PASTEUR Act: “Antimicrobial resistance has become a growing crisis in recent years,” causing more than 35,000 U.S. deaths annually, but market failures mean we lack R&D. “Americans understand that we must take every reasonable and responsible measure to prevent future public health crises.”
What’s next for NSCEB: “My goal as Chair, and the priority of the Commission as a whole, is to educate my colleagues in Congress on the urgency of this moment and show them that turning our recommendations into law is of vital necessity for our nation’s future.” Read more at Bio.News. |
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CMS listens to BIO on MDRP policies that threatened patient-first innovation |
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BIO is pleased to see that the new Centers for Medicare and Medicaid Services (CMS) rules governing drug rebates in Medicaid excluded several provisions that would have harmed a patients-first innovation ecosystem.
What happened: The final rule for "Medicaid Program: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (MDRP)" was published Sept. 20, more than a year after the first proposal was released.
BIO provided feedback to CMS throughout the process through an evidence-driven letter and meetings with multiple agencies, bipartisan and bicameral engagement with lawmakers, and educating advocacy groups and providers.
Why it matters: Earlier proposals would have increased uncertainty, devalued innovation, and hampered patient access. Ultimately, the rules avoided most of these pitfalls: - CMS will not “stack” different rebates that drug manufacturers offer on medicines, which would artificially drive prices down and threaten the viability of the Medicaid market.
- CMS will not survey manufacturers of certain drugs for extensive details on pricing. The burdensome data collection would have raised the possibility of CMS attacks on innovative products based solely on price.
- CMS won’t institute a new definition of “vaccine” that might have reduced access to a range of innovative vaccines.
- CMS finally conforms its regulation to a 2022 court decision, barring the use of patient assistance dollars, when retained by pharmacy benefit managers (PBMs) as a part of an accumulator program, from being used to lower the Medicaid best price. Had the original rule been implemented, it would have imperiled patient copay support.
COD concern: However, while CMS narrowed the definition of “covered outpatient drug” (COD), it still allows for some bundled drugs to be included, as long as certain requirements are met. This could compromise direct reimbursements that allow providers to be fully reimbursed for cutting-edge biotech treatments.
Read more at Bio.News.
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FDA approves first novel antipsychotic in decades. Cobenfy, made by BIO member BMS, has been shown to treat schizophrenia without side effects like sluggishness and weight gain. Earlier drugs have worked by blocking a dopamine receptor. “Cobenfy, also influences dopamine levels, but it does so indirectly, by changing levels of another neurotransmitter, acetylcholine,” according to The New York Times.
CSL Seqirus was awarded its fifth avian influenza pandemic preparedness award from Biomedical Advanced Research and Development Authority (BARDA). The multi-year $121.4M award will enable the expansion of the MF59® adjuvant inventory to 40 million equivalent doses, said the BIO member company. Read our past coverage of the company’s avian flu work at Bio.News. |
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Beltway Report: What's Ahead in Washington
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Congress left town early due to Hurricane Helene in the Southeast. Stay safe this weekend. |
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