Congress Passes Long-Awaited Appropriations/COVID-19 Relief Package

Ending months of haggling between lawmakers, Congress passed an omnibus appropriations bill and COVID-19 relief package late Monday with a seven-day continuing resolution in place to keep the government funded at fiscal 2020 levels until the legislation is signed into law as expected.

The $2.3 trillion combination package of appropriations for the remainder of the fiscal year and $900 billion in COVID-19 relief measures passed by the House will grant an increased $42.25 million to the FDA for fiscal 2021 and $55 million to the agency for coronavirus-related relief.

The $1.4 trillion spending bill means the agency will receive a total $3.2 billion in funding, or $5.876 billion when counting user fees, in fiscal 2021. This compares with fiscal 2020 funding of $3.16 billion in appropriations, with a total budget of $5.8 billion including user fees.

Of the increased $42.25 million going to the FDA, $22 million is for medical product initiatives. This includes $5 million for modernizing flu vaccines, $2 million for human drug compounding, $3.5 million for a foreign unannounced inspection pilot and $2.5 million for rare cancer treatments. It also gives the agency $7 million for artificial intelligence and other emerging technologies.

On the medical device side, the appropriations bill gives the agency $9 million to establish a knowledge management system and portal.

The omnibus spending bill additionally hands the agency $55 million in emergency funding for developing and reviewing medical countermeasures, vaccines, therapies and medical devices used to fight the pandemic. The funds will help agency efforts to monitor the supply chain.

Notably, $30.5 million of the pandemic emergency funding will be used for the advanced manufacturing of medical products; $9 million will go toward product development; $5 million will be used for after-action review activities; $7.6 million is granted for public health research and response investments; and $1.4 million will be used for data management operation tools, according to the legislation.

The package passed by the House also includes a $900 billion COVID-19 relief component that funds a number of different measures for Americans impacted by the pandemic. — James Miessler

Note: Updated on Dec. 22, 2020