$3.2 billion FDA budget clears U.S. House

House lawmakers passed a four-bill appropriations minibus for fiscal year (FY) 2021 that includes a measure to give FDA the ability to recall both OTC and prescription drugs. Moreover, “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.” In addition, FDA’s proposed budget allocates funds for ramping up influenza vaccine manufacturing technologies and creating a cannabidiol regulation framework. Medical product development would receive a $70 million appropriation as part of the 21st Century Cures Act. Overall, HR 7608 proposes $3.21 billion for FDA, up more than $40 million from the 2020 enacted level. Senate lawmakers must now work on the FY 2021 FDA budget, but it is unclear if a budget will be finalized before the beginning of the next fiscal year on October 20, or if the agency will need to start FY 2021 with funding from a Continuing Resolution.