Appropriations bill would give FDA $269M boost over FY2018 budget

With one day left before the US government faces another shutdown, the House and Senate are poised to pass a seven-bill spending package on Thursday to fund large portions of the federal government through FY2019. And President Donald Trump has said he will sign the bill.

The spending package comes near the end of a three-week stopgap funding measure to allow the government to reopen after a record 35-day partial government shutdown that began on 22 December 2018 after President Donald Trump refused to sign a short-term spending bill over his demand for $5.7 billion for a wall along the southern border.

Included in the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies 2019 appropriations bill is $3.068 billion in discretionary funding, a $269 million increase over FY2018 levels. The increase in budget authority, if enacted, would be the largest increase the agency has seen since FY2010.

If the FDA is funded at the levels set in the funding bill, the agency’s total program level will be $5.67 billion, including the roughly $2.5 billion in user fees the agency is expected to collect.

According to an explanatory statement circulated along with the bill, the $269 million in new funding for FDA includes “$47,000,000 to combat the Opioid Epidemic, $38,500,000 to Promote Domestic Manufacturing; $12,000,000 for a New Domestic Drug Industry; $6,000,000 for MedTech Manufacturing; $50,700,000 for New Medical Data Enterprise; $25,000,000 for the Growth and Transformation of Digital Health; $43,300,000 for New Platform for Drug Development, including a $5,000,000 increase to fully fund FDA’s Oncology Center for Excellence; $25,100,000 for Modernizing Generic Drug Development and Review; and $10,000,000 for Investment and Innovation for Rare Diseases.”

The bill, while including $22.54 billion in “total border security funding” only includes $1.375 billion for 55 miles of physical barriers along the southern border, less than a quarter of what Trump is requesting.

First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email for more information.

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