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The Latest in Regulatory and Reimbursement
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A new FDA Commissioner and NIH Director have been confirmed and sworn into their leadership roles. The Department of Health and Human Services has terminated 10,000 employees as part of reductions in force. A Senate vote is pending to confirm the CMS Administrator and President Trump has announced that he intends to nominate a new CDC Director. Manufacturers have agreed to participate in the second cycle of the Medicare Drug Price Negotiation Program and the CMS Innovation Center has recently cancelled payment and demonstration models.
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NIH & FDA Leadership
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On March 25, the Senate confirmed Dr. Jay Bhattacharya as NIH Director on a party line vote of 53-47, and Dr. Martin Makary as FDA Commissioner with a vote of 56-44. Both agency leaders were sworn in by President Trump and began in their new roles last week. |
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Reductions in HHS Workforce
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Last week, 3,500 FDA staff, 1,200 NIH employees and 300 CMS workers were terminated as part of large-scale reductions in force. While FDA product reviewers and inspectors were not affected, administrative and support staff were let go across all centers.
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CMS Administrator Update
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Last Thursday, the Senate confirmed Dr. Mehmet Oz to lead the Centers for Medicare and Medicaid Services in a party-line vote of 53-45. As Administrator, he will oversee the single largest payer for healthcare in the U.S. |
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CDC Director Nomination
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President Trump announced that he intends to nominate Susan Monarez as CDC Director. Last year, Biocom California hosted a roundtable in San Diego with her, in her previous capacity as ARPA-H Deputy Director. |
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Agreements Signed for Drug Price Negotiations
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CMMI Cancels Payment Models & Demonstrations
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The CMS Innovation Center is canceling four payment models by December 31 and stopping two demonstration projects, the Medicare $2 Drug List and the Accelerating Clinical Evidence demonstration, before they begin. |
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Congratulations to Biocom California members, Visby Medical and GSK, on their recent FDA marketing authorizations for products related to women’s health!
Last month, the FDA granted marketing authorization for Visby Medical’s Women’s Sexual Health Test which is the first home test to diagnose Chlamydia, Gonorrhea and Trichomoniasis.
The FDA also approved GSK’s Blujepa, which is the first in a new class of oral antibiotics for the treatment of uncomplicated urinary tract infections in female adults and pediatric patients.
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Biocom California
For over 29 years, Biocom California has helped move the life science industry forward with transformative resources that enable companies to make meaningful connections. As the largest life science association in the world, we connect our members to each other so they can collaborate and work stronger and smarter together. We connect organizations to capital investment and purchasing solutions so they can grow faster and work more efficiently. We’re their link to advocacy that fights for innovation and we provide an environment where their business and talent can thrive. Biocom California is how the life science industry gets connected.
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