On July 11, 2024, the Senate Appropriations Committee met for a full committee markup and approved subcommittee allocations for the Fiscal Year 2025 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act. The Committee advanced the funding bill in a bipartisan vote, which includes a $22 million increase in discretionary funding for the FDA.
The Senate Appropriations report on its funding bill outlines several directives for the FDA’s regulatory work in the upcoming fiscal year. Specifically, the Senate appropriators have requested the FDA to develop a “Rare Disease Innovation Agenda,” within 180 days, to enhance communication with the rare disease community and promote collaboration on novel endpoints, biomarker development, real-world data usage, and innovative trial designs. The agenda should incorporate public input, with a summary and recommendations posted on the FDA’s website.
Additionally, the report requests that the FDA report on its artificial intelligence (AI) efforts within 180 days, determining if new statutory authorities are needed for post-approval oversight of AI in medical devices within 90 days. The report also directs the FDA to unify its accelerated approval processes, encourage manufacturers to adopt innovative technologies to address drug shortages, and improve supply chain transparency. Furthermore, the Committee expressed its support for the expedited development of Alzheimer’s treatments and its concern about other agencies potentially limiting patient access to these therapies.
View the bill text, bill summary, full report, and press release
Last Updated on July 23, 2024 by Aimed Alliance
