Politics, Policy & Law
Congress passes American Rescue Plan with $500M for FDA’s COVID-19 activities, and billions for vaccines, testing and surveillance
The American Rescue Plan, passed Wednesday by the House of Representatives, includes $500 million for FDA’s COVID-19 activities and billions of dollars to support acquisition and deployment of vaccines, therapies and tests. President Joe Biden is expected to sign the legislation into law on Friday.
The legislation will give FDA a great deal of discretion to allocate the funding bolus. Allowable uses include evaluating 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 COVID–19, as well as evaluating advanced continuous manufacturing activities related to vaccine production.
Congress specified that FDA can use the funding to review devices authorized to treat, prevent, or diagnose COVID–19. The funding is needed in part because emergency use authorizations have been to rapidly deploy COVID-19 countermeasures and there are no user fees associated with EUAs.
The agency is also permitted to use the funds to conduct of inspections of medical product manufacturing facilities that were delayed or canceled for reasons related to COVID.
Other uses specified in the bill include oversight of the supply chain and mitigation of shortages of vaccines, therapeutics and devices for COVID-19.
Beyond FDA, the bill provides $6 billion for COVID-19 medical countermeasures R&D, manufacturing and acquisitions.
It allocates $1.8 billion for genomic sequencing and surveillance.
The law also funds the establishment and operation of a disease warning system and forecasting system aimed both at tracking COVID-19 and ongoing surveillance of emerging biological threats worldwide.