House Passes FDA Spending Bill with $41 Million Boost
The U.S. House of Representatives has passed an FDA spending bill that sets the agency’s 2021 discretionary funding at $3.212 billion, an increase of $40.8 million (less than 1% increase) above the 2020 enacted level. Total funding for the agency, which includes user fees, is $5.99 billion. The measure is practically unchanged from when it began proceeding in the House appropriations subcommittee earlier this month.
“Within this total, the Committee provides targeted increases for medical product and food safety activities, including new initiatives to advance new influenza vaccine manufacturing technologies, support for a new, crosscutting activity enhancing food and medical product safety and includes funding to develop a framework for regulating CBD products,” a summary (page 10) of the bill says. “In addition, the 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. The bill also appropriates $70 million to accelerate medical product development as authorized in the 21st Century Cures Act.”
Additionally, the bill includes language providing FDA with mandatory recall authority for prescription and over-the-counter drugs. It also includes language directing the agency 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 inspectors.
In response to the bill’s passage, the Alliance for a Stronger FDA thanked House members for its “continuing support of the resources FDA needs to meet its expanding responsibilities. 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.”
Meanwhile, the Senate has not set any dates for mark-ups, which the Alliance says could come in September, but are more likely to be post-Election Day. If the Senate does not act by 9/30, FDA likely will be funded under a continuing resolution (CR). “The consequences of a CR are severe, even though they may be temporary,” the Alliance says. “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, 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.”