House Appropriations advances FDA funding bill

Regulatory NewsRegulatory News
| 01 July 2021 | By Michael Mezher 

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


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