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  4. Government Funding Bill Includes FDA User Fees Without Additional Policy Riders

A bill funding the federal government through December 16 passed Congress on Friday to avoid a partial government shutdown. The continuing resolution funding bill also included a five-year renewal of Food and Drug Administration (FDA) user fees collection but does not include additional policy riders.

On September 27, the Senate Committee on Health, Education, Labor and Pensions, and the House Committee on Energy and Commerce agreed to reauthorize the FDA user fee with the understanding that additional policy riders would be considered for inclusion in an end of year omnibus package.

Policies debated earlier this year, including the Verifying Accurate Leading-edge IVCT Development (VALID) Act could be attached to an omnibus legislative package later this year before government funding runs out on December 16. Given the urgency to fund the government and the FDA before a September 30 deadline, lawmakers opted to enact “clean” legislation without other policies attached. Previously, the House and Senate had considered several FDA-related provisions, including measures to prevent future pandemics, oversight of dietary supplements, cosmetics regulation, generic drug manufacturing, and other bipartisan measures such as the VALID Act.

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