FDA's FY2022 Senate funding bill clears Appropriations committee

Regulatory NewsRegulatory News | 05 August 2021 |  By 

The Senate Appropriations committee has completed its markup of the FY2022 budget for the US Food and Drug Administration (FDA), advancing by a 25-5 vote a bill that would hold the agency to a $200 million increase in its budget authority.
The bill exited the Appropriations subcommittee responsible for FDA funding on Monday with no objections to the Senate’s proposed 6% increase for the agency over FY2021 figures. (RELATED: Senate subcommittee advances FY2022 FDA funding bill, Regulatory Focus 03 August 2021)
In late July, the House passed a budget that would give FDA $3.471 billion in FY2022, $257 million more than the previous year. The Senate bill sets aside $3.414 billion in budget authority for FDA.

President Joe Biden’s proposed budget for FDA would have given a boost of $344 million, or about 8%, to the agency over FY2021 figures. (RELATED: House Appropriations advances FDA funding billRegulatory Focus 1 July 2021; Biden’s first budget request seeks $6.5 billion for FDARegulatory Focus 1 June 2021)
The Senate’s total proposed budget allocation also includes $2.723 billion in user fees, with $1.142 billion coming from prescription drug user fees. Generic drug user fees would contribute $528 million, while medical device user fees would make up $241 million of this portion of the budget. Biosimilar user fees would account for $43 million.
FDA salaries and expenses would make up $3.399 billion, more than the $3.201 billion enacted for FY2021 but less than the $3.527 requested for FY2022.
The Appropriations committee’s report called out several initiatives which are slated for funding boosts in the Senate’s proposed budget, or that the committee deemed especially important.
“Information technology continues to be a priority for the agency and the bill includes an increase of $25 million,” according to the Appropriations committee’s summary statement.
Foreign high risk inspections are among FDA’s high-priority activities, and the report notes that the proposed budget “maintains funding for the evaluation of foreign high-risk sites to allow the FDA to 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.” The Appropriations committee directs FDA to prepare a report that will help the agency better target overseas inspection activities.
FDA’s inspection efforts are to receive an additional $15 million in FY2022 according to the proposed Senate budget; in addition, the budget would allocate an increase of $24 million to FDA’s work at international mail facilities and US ports of entry to target opioids and other illicit and counterfeit drugs from coming into the US. “Millions of illegal products, including opioids, enter these facilities from countries all over the world.  FDA is on the front lines to ensure these products do not make it into commerce and these additional funds will allow FDA to continue this important work,” according to the committee’s summary.

In the proposed FY2022 budget, FDA is allocated an additional $5 million to address gaps in the development of therapies for rare cancers, with specific focus directed to collaborative work with the National Cancer Institute’s developmental therapeutics program. Separately, FDA’s Center for Biologics Evaluation and Research (CBER) is to receive an additional $5 million to boost staff capacity in the Office of Tissues and Advanced Therapies and facilitate CBER’s ability to use existing expertise at its sister Center for Drug Evaluation and Research (CDER).
Biofilm regulatory science efforts would also receive a $500,000 increase to address the issue of biofilm contamination of multiple-use medical devices.
Several other FDA initiatives and programs received callouts in the budget report, with various requests to speed progress and report back to the Senate within a specified time frame. Specifically, the Appropriations committee’s report addresses FDA’s efforts to address the opioid epidemic, the need for a proposed rule on switching from prescription to over-the-counter licensing, and efforts to address drug and medical device shortages, especially concerning essential medicines. Nanotechnology research, innovations in glass packaging, and efforts to use innovative approaches to avoid animal testing were also called out by the report.
Other priorities for FDA, according to the report, should be ongoing work in addressing unmet need in systemic lupus erythematosus, inflammatory bowel diseases and Duchenne muscular dystrophy. When orphan drugs are reviewed, the budget bill encourages FDA to include at least two advisory committee members with expertise in the condition the drug is meant to treat, or in other relevant rare diseases.
The bill that encompasses the proposed budgets for FDA, along with the departments of Agriculture, Rural Development, and related agencies will next come before the full Senate for a vote.
Senate Appropriations committee report


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