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The Latest in Regulatory and Reimbursement
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The FDA has announced increased regulatory flexibilities for cell and gene therapy products and launched a plan to implement the PreCheck pilot program to support onshoring efforts. CDER has released its annual report highlighting last year’s new drug approvals and the White House unveiled its “Great Healthcare Plan.” CMS has published the list of the next 15 drugs selected for the Medicare Drug Price Negotiation Program and the agency has requested public feedback on approaches for strengthening the domestic PPE supply chain.
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FDA Increases CGT Regulatory Flexibilities
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The FDA announced an enhanced flexible approach on chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT) which affects development, specifications and process validation for products. |
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White House Announces “Great Healthcare Plan”
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The Trump Administration unveiled “ The Great Healthcare Plan,” outlining reforms which it states will lower drug prices and insurance premiums, increase price transparency and hold insurers and middlemen accountable. |
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FDA Launches Roadmap for PreCheck Implementation
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The FDA announced the implementation roadmap for the PreCheck Pilot Program. The roadmap details the application process and timeline that the agency will use to determine the program’s first cohort of new pharmaceutical manufacturing facilities. The FDA will accept applications starting February 1. |
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CDER Releases Drug Approval Annual Report
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CDER recently released its 2025 New Drug Therapy Approvals report highlighting 46 novel drug approvals, 34 of which were new molecular entities and 12 biologics. The report states that the number of approvals last year was similar to the average number of drug and biologic approvals over the last five years. |
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CMS Publishes Next 15 Drugs for Price Negotiations
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CMS selected the next 15 drugs for the Medicare Drug Price Negotiation Program and these drug manufacturers will have until February 28 to agree to participate in the program. |
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CMS Seeks to Strengthen Domestic PPE Supply Chain
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CMS is seeking public feedback on ways to promote purchasing by U.S. hospitals and strengthen the domestic supply chain for personal protective equipment (PPE) and essential medicines.
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Request for Comments
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Biocom welcomes feedback from members on the following proposed demonstration models. Click here to submit comments via email. |
► CMS GLOBE and GUARD Demonstration Models
- The Center for Medicare and Medicaid Innovation (CMMI) has proposed two new, mandatory most-favored nation (MFN) pricing models, GLOBE and GUARD, for certain drugs covered under Medicare Part B and D, respectively.
- As part of these models, manufacturers would be required to pay a rebate if a current Medicare drug price exceeds an international benchmark price.
- The rebate would only be paid for specified drugs used by 25% of Medicare Part B beneficiaries and 25% of Part D enrollees who reside in randomly selected geographic regions in the United States.
- CMS is collecting public comments on the proposed GLOBE and GUARD demonstration models until February 23.
This comment opportunity may be of interest to drug developers.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Congratulations to Sentynl Therapeutics on receiving FDA approval for Zycubo, the first and only treatment approved for Menkes disease, a rare and fatal genetic condition.
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Biocom
For over 30 years, Biocom has advanced the life science industry with transformative resources that accelerate innovation. We help companies build meaningful connections and gain valuable insights through Conferences & Events, deliver access to Funding & Partnering opportunities, provide Group Purchasing solutions that drive efficiency and savings, champion Policy & Advocacy that protects and advances the innovation ecosystem, and strengthen talent pipelines through Workforce Development. Biocom is how the life science industry gets connected.
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