Bioscience Bulletin – December 5, 2025

Dr. Richard Pazdur announced his retirement from FDA, weeks after being named the head of the Center for Drug Evaluation and Research (CDER). Disagreements with FDA policies and leadership are cited as motivations for his departure. Dr. Tracy Beth Høeg has been named as his replacement. She is close to to Director Makary, and will be CDER’s fifth leader this year.

Center for Biologics Evaluation and Research (CBER) Director Dr. Vinay Prasad, indicated plans to more stringently regulate vaccine development. He cited child mortalities attributable to COVID-19 vaccines, as the rationale, however, the validity of this claim is disputed. 12 former FDA commissioners, condemned this move in a piece published in the New England Journal of Medicine.

The agency issued a request for information (RFI) to gather views on increasing access to nonprescription drugs that can be dispensed without a doctor’s supervision. Comments are due February 2, and information gathered will inform a public meeting later in 2026. Concurrently, the Director of the Office of Nonprescription Drugs, Theresa Michele, was transferred to another position at the agency.

Director Marty Makary announced that the agency will lower the number of clinical trials required for most medical product approvals from two to one. He indicated that this reflects current practice where the agency allows many drugmakers to submit one trial for evaluation, particularly in situations where conducting two trials is not feasible.

A draft guidance on reducing testing of non-human primates for monoclonal antibodies was posted, as were final guidances on a handful of other topics.

The agency announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot on Friday. This collaboration with CMS, is designed to expand access to chronic disease digital health devices or services. Up to ten companies will be selected participate in the pilot, which enables them to commercialize without going thorough standard or 510(k) clearance processes. Submissions for statements of interest will open in January.

The agency announced the ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model, to evaluate outcome aligned payments to expand access to technology supported care for chronic disease. This would be a voluntary ten year program that diverges from a traditional fee for service model. A directory of digital health technologies and vendors will be maintained to facilitate ACCESS model participation and compliance. Applications to participate in the first performance period starting in July, are due in April.

The agency published a final rule indicating that Medicare hospital payments would increase in 2026, including an $8 billion increase in  reimbursement for outpatient services at acute care hospitals and $9.2 billion to ambulatory surgical centers.

The agency posted prices for 15 drugs subject to the Medicare Drug Price Negotiation Program, and these prices will take effect in 2027. Reported savings are ~$8.5 billion.

Former Congressman & Louisiana Surgeon General, Dr. Ralph Abraham, is now Principal Deputy Director at the agency. He is a noted critic of vaccination and immunization mandates.

 On Friday, the Advisory Committee on Immunization Practices (ACIP) voted to rescind the 35 year old recommendation that all babies be given hepatitis B vaccines shortly after birth. President Trump praised the decision and subsequently issued a memo directing HHS to align US childhood vaccine recommendations with those in peer nations. By contrast, Senate HELP Committee Chair Cassidy strongly criticized the decision and decried ACIP’s credibility.

340B: A coalition of hospitals sued the department over implementation of the 340B Rebate Model Pilot program, that would require them to purchase certain drugs at market rate upfront starting in January.

Drug Pricing: The Administration announced a deal with the UK to allow tariff free pharmaceutical product imports from that country. The British government will reduce the rebates drug companies pay to the UK National Health Service, and increase spending on drugs by 25%. This is effort is aligned with the President’s goal of ending what he calls ‘freeloading’ by other countries on American R&D.

Genesis Mission: Key to this new AI initiative is the ‘American Science & Security Platform’, which will integrate and secure infrastructure like national-lab supercomputers, federal scientific datasets, and AI modeling tools, with the purpose of training scientific foundation models to address major challenges, including in biotechnology and advanced manufacturing.