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The Latest in Regulatory and Reimbursement
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Biocom provided public comments on the PDUFA VIII commitment letter at the FDA’s public meeting. CMS has finalized its Global Benchmark for Efficient Drug Pricing Model. The FDA launched a new pilot program aimed at expediting the time it takes to initiate a first-in-human study and issued a new final rule on the use of new approach methodologies. HHS announced permanent leadership at FDA drug and biologics centers. 40 states signed agreements to participate in the CMS Most Favored Nation pricing model.
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Biocom comments on PDUFA VIII Commitments
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CMS Finalizes GLOBE Rule
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Last month, Biocom’s President and CEO, Tim Scott, provided in-person comments at the FDA’s Prescription Drug User Fee Act (PDUFA) reauthorization public meeting.
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CMS finalized its Global Benchmark for Efficient Drug Pricing (GLOBE) Model, a most-favored-nation pricing model for certain Medicare Part B drugs that Biocom opposes.
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New Expedited IND Pilot Begins
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FDA Issues New NAM Rule
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FDA has launched the expedited Investigational New Drug (IND) pilot program to accelerate the time it takes from identifying a drug to initiating a first-in-human clinical trial. Applications due October 30.
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FDA issued a direct final rule updating regulations to clarify that new approach methodologies (NAMs) can be used, where appropriate, to generate safety information for drugs and biological products. |
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Permanent CDER and CBER Directors Announced
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States Agree to Participate in GENEROUS Model
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Michael Davis and Karim Mikhail, acting directors of the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), were selected by HHS as directors of the centers.
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40 states and Puerto Rico have signed agreements to participate in the GENErating cost reductions for U.S. Medicaid (GENEROUS) Model, which would provide most-favored-nation pricing for certain prescription drugs to people with Medicaid. |
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Upcoming Regulatory and Reimbursement Events:
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Featured Member
Congratulations to Biocom member, Ultragenyx, on its FDA approval of Fayuvi, the first treatment for pediatric patients with Sanfilippo syndrome type A.
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Biocom Policy & Advocacy
Biocom is the leading advocate for California’s life science sector. Our Policy & Advocacy staff across the Bay Area, Los Angeles, San Diego, Sacramento and Washington, D.C. work with lawmakers and regulators to shape policy and strengthen government relations through coordinated regional, state and federal engagement, supporting industry growth and keeping California globally competitive.
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San Diego | Bay Area | Los Angeles | Seattle | Sacramento | Washington D.C. | Tokyo
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Biocom Headquarters
10996 Torreyana Road, Suite 200, San Diego, CA 92121
Bay Area
1 Tower Place, Suite 150, South San Francisco, CA 94080
Los Angeles
15260 Ventura Blvd., Suite 725, Sherman Oaks, CA 91403
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