Centennial State News

Congress must pass a government funding package by Friday at midnight in order to avert a government shutdown.  Earlier this week, passage of a $1.7 trillion omnibus spending package looked likely, but the bill has been snarled by a border policy dispute.  It is now unclear whether the omnibus spending package will be passed in time or whether Congress will have to move forward with a short-term funding fix through a continuing resolution (CR) extending into next year. 

What’s Included in the Omnibus Spending Package? 

If the fiscal year 2023 Omnibus Appropriations bill is passed, this 4,000+ page bill would impact life sciences in a number of ways.  The explanatory statements and bill summaries for each of the twelve appropriations bills are available here and a topline summary of all twelve bills is available here.  The package includes $47.5 billion for the National Institutes of Health, $9.2 billion for the Centers for Disease Control and Prevention, $1.5 billion for Advanced Research Projects Agency for Health (ARPA-H, the President’s new initiative to fight cancer), and $950 million for the Biomedical Advanced Research and Development Authority.  Below is a non-exhaustive list of some highlights. 

What’s In: 

The bill includes policies originally considered during User Fee Agreement negotiations.   

• The U.S. Food and Drug Administration (FDA) would be tasked with developing Accelerated Approval (AA) reforms. 
• There are various provisions related to: clinical trial modernization and diversity, “platform” technologies for drugs and vaccines, and a new review pathway for designating advanced manufacturing technologies. 

There would be increased funding for key pandemic preparedness and public health priorities, including: 

• The Administration for Strategic Preparedness and Response (ASPR), 
• The Biomedical Advanced Research and Development Authority (BARDA), and 
• The Strategic National Stockpile. 
• Many of the provisions from the proposed PREVENT Pandemics Act are included as well. 

There are several provisions related to antimicrobial resistance (AMR): 

• Antifungal Research and Development (commonly known as the FORWARD Act), 
• Advancing Qualified Infectious Disease Product Innovation (from the PREVENT Pandemics Act), and  
• CDC Laboratory Capacity. 

What’s Out: 

• The Verifying Accurate Leading-edge In Vitro Clinical Tests (IVCTs) Development (VALID) Act 
• The Pioneering Antimicrobial Subscriptions to End Up-Surging Resistance Act (PASTEUR Act) 
• The Medicare Multi-Cancer Early Detection Screening Coverage Act (MCED) 
• Changes to the Section 174 rules requiring capitalization and amortization of research and experimentation (R&E) expenses 

While we are disappointed that these key bills did not make it into this omnibus package, we are appreciative of the life sciences community’s advocacy and are hopeful that this legislation may proceed next year. 

What’s Next? 

CBSA will continue to keep a close eye on federal developments and will work with national partners to build on the momentum generated by this year’s progress going into the 118th Congress. 

Original source can be found here.