Shutdown:

The longest ever government shutdown is now over, but a return to regular agency operations will take time. On Wednesday, the House by a vote of 222-209, passed a package to re-open the government that was cleared by the Senate on Sunday. It was immediately signed into law by President Trump. Key part of the package are:

• Full year funding of three appropriations bills: Agriculture-FDA, Legislative Branch, and Military Construction-Veterans Affairs
• A continuing resolution (CR) to fund the majority of agencies supported by the remaining nine appropriations bills through January 30, including the Department of Defense (DoD) and most of HHS.
• Return to work and back pay for furloughed workers
• A promised Senate vote on extending expiring enhanced Affordable Care Act (ACA) tax credits, although there is no guarantee of passage

Congress:
On Thursday, the Senate Finance Committee will convene a hearing on the 'Rising Cost of Health Care’ and the House Ways and Means Health Subcommittee will convene a hearing on 'Modernizing Care Coordination to Prevent and Treat Chronic Disease'

Administration & Agencies:

FDA:

• Dr. Richard Pazdur was named the head of CDER on Tuesday. He is the founding director of the FDA’s Oncology Center of Excellence (OCE).
• New Pathway for Rare Disease Therapies: Director Makary and CBER Director Vinay Prasad outlined a new framework for regulatory approval of bespoke customizable therapies in a piece in the New England Journal of Medicine. This is being referred to as the ‘Plausible Mechanism Pathway’ and aims to:
  • Scale single-patient approaches, citing a case where a baby with a rare disorder was treated with a therapy that used CRISPR gene editing technology
  • Prioritize rare diseases including those with single digit incidences, where conducting conventional clinical trials is difficult or impossible
  • Facilitate approval of personalized medicine therapies that demonstrate a likely biological mechanism, and improvement of clinical outcomes
  • Move the agency towards approving platform technologies that can be customized to successfully treat different diseases
• Commissioner’s National Priority Voucher (CNPV) Pilot: The agency announced a second round of recipients of CNPVs. This program allows for accelerated review of drug candidates for companies aligned with national health priorities including domestic manufacturing. The total number of awardees is now at 15.

CDC:

The Advisory Committee on Immunization Practices (ACIP) will meet on December 4 and 5, to revisit its discussions from September on the childhood vaccine schedule, and newborn hepatitis B vaccination, and potentially issue new recommendations.

MAHA Summit:

A closed door event on Wednesday brought together key officials, including Vice President Vance and Secretary Kennedy, biotech industry executives and activists to discuss the Administration’s progress in implementing its MAHA agenda. Details on readouts are limited, but topics discussed include:

• The recently announced policies of expanding access to anti-obesity durgs
• The continued role of NIH in supporting research
• The role of AI in healthcare
• Food as medicine
  Drug costs, and ongoing efforts to lower them.