House Appropriations advances FDA funding bill

The House Committee on Appropriations on Wednesday advanced legislation that would provide the US Food and Drug Administration (FDA) with $3.45 billion in budget authority for FY2022, a $257 million increase over the FY2021 enacted level.

In a voice vote, the committee moved to send the $26.55 billion bill to the full House for consideration, less than a week after the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee’s markup of the bill. The Senate Committee on Appropriation’s counterpart subcommittee has held a hearing examining President Biden’s FY2022 budget request for FDA, but has yet to release its version of a funding bill. (RELATED: House subcommittee proposes $257M increase for FDA in FY2022, Regulatory Focus 25 June 2021)

“Our bill increases the Food and Drug Administration’s funding by $257 million over last year’s level which will improve safety efforts and accelerate medical advancements,” said Subcommittee Chairman Sanford Bishop (D-AL).

The bill was advanced as amended by a manager’s amendment and two agriculture-focused amendments relating to line speed for poultry production and an amendment that would prohibit Chinese state-owned companies from purchasing agricultural land or participating in US Department of Agriculture programs.

Bishop described the manager’s amendment as “making non-controversial technical changes and addressing a number of member requests in the bill and the report. The amendment has been drafted in very close consultation and cooperation with Ranking Member Fortenberry [R-OK].”

In total, the bill would provide $6.27 billion in funding for FDA, including $2.817 billion in user fees paid for by industry.

The accompanying committee report on the bill makes a number of requests of FDA related to the agency’s oversight of medical products. Some of the issues highlighted in the report include the agency’s aging 510(k) guidance; the inclusion of pharmacogenomic data in product drug labeling; advancing innovative, inclusive clinical trials for Alzheimer’s disease; the feasibility of using AI technology to assess the medical product supply chain; and a request for FDA to support the development and implementation of continuous manufacturing technologies for domestic active pharmaceutical ingredient (API) production.

The report also calls on FDA to submit a report within 90 days of the bill’s enactment on the impact of COVID-19 on clinical trials, particularly those for drugs intended to treat rare diseases. Other provisions in the report include a request for FDA to submit a report to the committee on its efforts to improve international pharmaceutical quality standards and for the agency to develop a report on the feasibility of requiring drug manufacturing facilities to list all APIs and drug products the produce that are intended for the US market and the feasibility of implementing a “letter grading system for drug manufacturing facilities.”

The bill will now be reported to the full House for consideration.

Press release, markup, bill, amendments, report

House Appropriations advances FDA funding bill

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