FDA-related Provision of House Reconciliation Bill

Q: What is contained in the FDA-related provision of the House Reconciliation bill?

A: There is a provision that would make $500 million in no-year funds available to support COVID-19 activities at FDA. The specific text follows, which is re-formatted for clarity:

SEC. 3004. FUNDING FOR COVID–19 VACCINE, THERAPEUTIC, AND DEVICE ACTIVITIES AT THE FOOD AND DRUG ADMINISTRATION. In addition to amounts otherwise available, there is appropriated to the Secretary for fiscal year 2021, out of any money in the Treasury not otherwise appropriated, $500,000,000, to remain available until expended, to be used for

1. the evaluation of the continued performance, safety, and effectiveness, including with respect to emerging COVID–19 variants, of vaccines, therapeutics, and diagnostics approved, cleared, licensed, or authorized for use for the treatment, prevention, or diagnosis of COVID–19;
2. facilitation of advanced continuous manufacturing activities related to production of vaccines and related materials;
3. facilitation and conduct of inspections related to the manufacturing of vaccines, therapeutics, and devices delayed or cancelled for reasons related to COVID–19;
4. review of devices authorized for use for the treatment, prevention, or diagnosis of COVID–19; and
5. oversight of the supply chain and mitigation of shortages of vaccines, therapeutics, and devices approved, cleared, licensed, or authorized for use for the treatment, prevention, or diagnosis of COVID–19 by the Food and Drug Administration.

Q: What did the Alliance say about the FDA funding provision in the House reconciliation bill?

A: The Alliance’s statement on the FDA funding provisions in the House reconciliation bill:

The FDA stakeholder community appreciates and supports the House Energy and Commerce Committee’s decision to include $500 million in no-year money to support COVID-19 activities at FDA. This assures that FDA has the funds it needs as its workload grows and shifts in response to the pandemic. Neither the pandemic nor FDA responsibilities in this area can be neatly segmented by fiscal year, so the flexibility provided by these funds is enormously valuable.

Apart from its COVID-19 work, FDA's mission and responsibilities have grown considerably in the last year and additional base funding will be needed in FY 22. We look forward to working with the Administration and the Appropriations committees to fully support the agency’s funding needs in areas such as food safety, cell and gene therapy, digital health, and advanced manufacturing.

Q: How was the $500 million for FDA determined?

A: During the reconciliation mark-up in the House Energy and Commerce Committee on February 11, Representative Eshoo, Chair of the Health Subcommittee, said that the $500 million was what FDA told her was needed to support its COVID-19 activities and assure the necessary flexibility to use the money when and where it would be needed to combat the pandemic.

Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.