House approves $3.2 billion FDA budget
The House of Representatives passed a four-bill appropriations minibus for fiscal year 2021 that includes an amendment giving the FDA the authority to recall drugs. The agency’s proposed budget also includes targeted boosts to spending for medical product and food safety activities and influenza vaccine manufacturing technologies.
Other targeted initiatives include cross-departmental initiatives designed to enhance food and medical product safety; additionally, “[T]he bill includes a strong focus on continuing FDA’s efforts to enable faster responses to foodborne illness outbreaks and increase the safety and cybersecurity of medical devices,” according to the House Appropriations Committee’s summary of the minibus.
Additional funds are targeted to develop a cannabidiol regulation framework, and medical product development would receive a $70 million appropriation, as provided by the 21st Century Cures Act.
The bill includes language providing FDA, for the first time, with mandatory recall authority for prescription and over-the-counter drugs,” according to the minibus summary. Additionally, “The bill includes language directing the FDA to develop a plan to identify, detain, and refuse the import of FDA-regulated products from a foreign establishment that did not allow physical access to FDA investigators.”
A total of $3.212 billion is slated for FDA in HR 7608, $40.8 million more than the 2020 enacted level. The $259.5 billion minibus package includes appropriations for State-Foreign Operations, Interior-Environment and Military Construction and Veterans Affairs in addition to the Agriculture-Rural Development-FDA appropriations.
The priorities and budget for FDA in the minibus are unchanged from the bill approved by the House Appropriations Committee on 9 July. At that time, the Alliance for a Stronger FDA thanked the House Appropriations Agriculture/FDA subcommittee in a blog post, while calling for increased levels of support for FDA: “We view the proposed $41 million increase in FY 21 as a vote of confidence in the agency, given the severe budgetary constraints for all federal programs. We believe the FDA will still need more resources in the coming fiscal year to fulfill its mission and we will continue to work with Congress to achieve that end,” said the Alliance.
Action on the FY 2021 FDA budget next comes from the Senate; it is uncertain whether a budget will be finalized before the beginning of the next fiscal year on 20 October 2020, or whether the agency will need to start fiscal year (FY) 2021 with funding from a Continuing Resolution (CR).
Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, stated that “The consequences of a CR are severe, even though they may be temporary. The FDA would need to carry out its programs using the FY 20 (prior year) funding levels, without the increased monies proposed for FY 21 by the House.”
“Further,” said Grossman, “FDA would be limited in its ability to start new initiatives (variously defined) for as long as it is on CR funding. Last (but hardly least), CRs create uncertainty, which makes program and personnel planning difficult.”
RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.