With the Inflation Reduction Act signed into law, Congress returns to Washington from August recess and Labor Day with all eyes on averting a government shutdown by passing federal funding legislation before the fiscal year ends Sept. 30. It is highly unlikely all 12 appropriations bills will clear Congress in time, and calls for a stopgap spending bill or continuing resolution (CR) to fund the government through the midterm elections have already circulated.
The Biden administration on Sept. 2 requested that lawmakers attach to the CR an additional $47 billion in emergency spending. The administration seeks $22.4 billion in COVID-19 supplemental funds to meet immediate domestic needs, including testing, research, and development of next-generation vaccines and therapeutics; support the global response to COVID-19; and prepare for future variants.
The administration also seeks funding to prevent and treat monkeypox domestically and globally, aid Ukraine, and provide relief for recent natural disaster events, including major flooding in Kentucky and wildfires in California. However, congressional staff have indicated the CR will likely be “clean” and not include emergency spending or additional policy riders.
FDA User Fee Agreement Deadline
The Food and Drug Administration faces a Sept. 30 deadline for the user fee amendment (UFA) program, which allows the agency to collect user fees from pharmaceutical, medical device, and other health care developers. Congress is negotiating reauthorization proposals for the Prescription Drug User Fee Act, Medical Device User Fee Amendments, Generic Drug User Fee Amendments, and Biosimilar User Fee Amendments.
While the House passed its reauthorization legislation in a bipartisan fashion and with relatively little fanfare in June, the Senate hit a snag when Senate Health, Education, Labor, and Pensions Committee Ranking Member Richard Burr (R-N.C.) opposed several amendments to increase the size and scope of the pending legislation. The two versions of the legislation must be reconciled before the current UFAs expire at the end of the fiscal year.
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