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# Senate Spending Bill has $50 Million Boost for FDA
- URL: https://www.fdaweb.com/senate-spending-bill-has-50-million-boost-for-fda/
- Published: 2020-11-11T12:00:00.000Z
- Updated: 2026-09-14T16:36:00.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148066

A U.S. Senate Appropriations Committee-released [bill](https://www.appropriations.senate.gov/imo/media/doc/AGRept.pdf?ref=fdaweb.com) for fiscal year 2021 proposes $3.21 billion in discretionary funding for FDA, which is about 3% ($90 million) less than the Trump Administration proposed in February ([see earlier story](https://www.fdaweb.com/trump-budget-proposes-flat-6-2-billion-fda-budget/)). Nonetheless, the Senate bill is $50 million (1.6%) more than the FY 2020-enacted $3.16 billion FDA discretionary funding. The only medical product program area seeing any increase (4%) is medical devices with its budget growing $17 million from $395 million in FY 2020 to a proposed $412 million for FY 2021 under the Senate bill. All other program Centers’ funding has been kept flat, and user fees under the bill would increase from $2.6 billion in FY 2020 to $2.69 billion in FY 2021.

In the bill, the Senate indicates that it is encouraged by FDA’s ongoing efforts to accelerate review and approval of cancer immunotherapies. The committee urges the agency to work with and provide guidance to the research community and pharmaceutical industry on standardized clinical trial design considerations for immunotherapy-based combinations in order to help clinicians better select optimal treatment options for their patients, as well as to expedite regulatory review of novel regimens.

Regarding decentralized trials, the committee says it is encouraged by the development of novel health digital technologies to facilitate the use of virtual decentralized clinical trials (DCTs) that would make it easier for patients to participate in trials, regardless of where they live. “Through telemedicine and digital health technologies, (e.g. connected sensors and direct data capture tools), DCTs are conducted geographically near the patient,” it says. The committee recommends that the FDA develop the necessary policy to advance the use of DCTs while still maintaining quality data necessary for FDA approval.”

Turning to foreign high-risk inspections, the committee encourages FDA to focus its inspection activities on the highest risk foreign suppliers and continue efforts to “develop and utilize targeted, risk-based, and efficient models that incorporate commercially available information as appropriate, including onsite facility verification about all foreign establishments for the purpose of regulatory compliance and surveillance of manufacturing practices.” It is directing the agency to provide it with an update on these efforts, including estimated efficiencies and concerns and plans to continue or expand these efforts in the future.

Additionally, the committee says it supports the agency’s work to “promote the domestic manufacturing of drug and biological products and encourages the FDA to increase its efforts to encourage the pharmaceutical industry to adopt advanced manufacturing technologies that have the potential to improve product quality.” The committee also directs FDA to brief the committee on its efforts to promote advanced manufacturing technologies.