Overview

The FY 2019 fiscal year bill provides a total program level of $5.7 billion.  The FY 2019 total funding includes $3.1 billion in budget authority and $2.6 billion in user fees. 

Budget Authority

The bill provides $3.1 billion in budget authority.  This is an increase of $184.6 million over FY 2018, which includes net increases of $11.0 million for Food Safety, and $173.6 million for Medical Product Safety, including an increase of $10.0 million in no-year funding for the 21st Century Cures Innovation Account, and $47.0 million for regulatory science, enforcement, and innovation activities to combat the opioid epidemic.  Included in the total of $47 million for Opioids, $20.0 million is set-aside to create a large-scale data warehouse to perform data analytics.  The bill also states that for the Foods program no less than $15,000,000 shall be used for inspections of foreign seafood manufacturers and field examination of import seafood.

User Fees

The bill provides $2.6 billion in user fees, including appropriating Over-the-Counter Monograph User Fee contingent upon the enactment of the Over-the-Counter-Monograph User Fee Act of 2019.

Key Initiatives

Food Safety – an increase of $11.0 million for Food Safety compared to FY 2018

• +$2.0 million for FSMA Cooperative Grants
• +$2.8 million for Food Import Safety
• +$5.0 million for Strengthening Food Outbreaks
• +$0.5 million for NARMS – Seafood
• +$2.0 million for Standard of Identity and Product Labeling
• +$1.5 million for Consumer Education and Outreach Regarding Biotechnology (for a total of $3.0 million)
• -$2.8 million in savings

Medical Product Safety – an increase of $173.6 million for Medical Product Safety compared to FY 2018

• +$47.0 million for Combatting the Opioids Epidemic
• +$38.5 million to Promote Domestic Manufacturing
• +$12.0 million for New Domestic Drug Industry
• +$6.0 million MedTech Manufacturing
• +$50.7 million for New Medical Data Enterprise
• +$25.0 million for Growth and Transformation of Digital Health
• +$43.3 million for New Platform for Drug Development
• +$25.1 million for Modernizing Generic Drug Development and Review
• +$10.0 million for Investment and Innovation for Rare Diseases
• +$10.0 million for 21st Century Cures (for a total of $70.0 million)
• -$94.0 million for Opioids International Mail

Facilities Activities (one-time increase)

Required Transfer: The bill directs FDA to transfer $1.5 million from FDA Headquarters (HQ) to HHS’ Office of Inspector General to support oversight of FDA’s expanded authorities.