The following was originally posted by MassBio CEO and President Kendalle Burlin O’Connell to LinkedIn on November 13, 2025:
After 43 days, the federal government has reopened. Unfortunately, today marks the 44th day since we last had the SBIR program to support early-stage companies and their innovation. Here’s this week’s policy update, including new leadership at CDER:
- New CDER Director Appointed: On November 11, Dr. Richard Pazdur, a 26-year veteran of the FDA and founding director of the Oncology Center of Excellence, was appointed director of the Center for Drug Evaluation and Research (CDER). He is known for developing initiatives that streamlined cancer drug approvals, including Project Orbis for international coordination, Project Facilitate for expanded patient access, and Project Renewal for updating drug labeling.
- FDA Plausible Mechanism Pathway: On November 12, the FDA proposed a new “plausible mechanism pathway” to support the approval of personalized gene-editing therapies. The pathway would allow approvals based on evidence that a treatment acts through a well-understood biological mechanism, successfully targets the intended genetic abnormality, and produces measurable clinical improvement, without requiring large traditional trials.
- Shutdown Ends: The House approved and President Trump signed the Senate-passed legislation to end the 43-day government shutdown, the longest in U.S. history. The deal extends funding for most agencies until January 30th and includes three full-year funding bills for other parts of the government. While the bill does not address expiring health care tax credits, Senate Democrats secured a promise for a vote on that issue by mid-December. Unfortunately, the SBIR program remains paused.
- MAHA Summit: A “Make America Healthy Again” summit was held in Washington on Wednesday, November 12th, and featured Vice President JD Vance and Health Secretary Robert F. Kennedy Jr. alongside other HHS leadership. The closed-door event, organized by MAHA Action, also included sessions from biotech executives, including Regeneron, CRISPR Therapeutics, and Neuralink, that covered topics ranging from AI in healthcare and reversing aging to food policy and biotechnology acceleration.
- New CMMI Payment Model: CMMI has launched the “Generous” model, a five-year voluntary program starting in January, which will negotiate lower Medicaid drug prices with pharmaceutical manufacturers based on international pricing from select countries. The model follows similar “most favored nation” deals with Pfizer, AstraZeneca, Novo Nordisk, and Eli Lilly.