Strong BA Support for FDA on Capitol Hill -- At Different Levels

Both House and Senate appropriators are showing strong support for the FDA. However, they did so with substantially different levels of funding and, by implication, different priorities. We are told that the Senate’s lower numbers were mostly driven by a lower spending allocation for the Ag/FDA subcommittee compared to their House counterparts. Nonetheless, we will be advocating for funding at the House level with some additional funding for food safety programs. As it stands now (committee-passed bills in both House and Senate):

• The House proposed an increase of $308 million in budget authority (BA) spending for FY 19. Of that, $259.5 million is for new medical product initiatives. Additionally, $30 million would go to programs to address opioids and another $20 million is aimed at infrastructure development and White Oak expansion. There is a $2 million offset from elsewhere in the FDA budget.
• The Senate proposed an increase of $159 million in BA spending. Of that, $88.5 million is for medical product initiatives. Additionally, $59 million would pay for opioid programs and $15.5 million for food safety initiatives. The food increases would go for FSMA cooperative agreements with states, food import safety, food safety outbreaks, and testing antibiotic resistance in imported seafood. There is a $4 million offset from elsewhere in the FDA budget.

Within these totals, both House and Senate committee bills would provide a $5 million increase to fully fund the Oncology Center for Excellence and add $20 million for investment and innovation in rare diseases. The bills would also fund (at different levels) two advanced manufacturing initiatives (one for drugs/biologics and one for medical devices) and an initiative to modernize the generic drug review process.For four other initiatives proposed by the Administration:

• New Domestic Drug Industry. FDA will expand engagement with outsourcing facilities and states to help the pharmacy outsourcing industry grow to meet its intended function and adhere to higher quality standards to protect patient health. The House committee bill would provide $12 million; the Senate committee would not provide any new funding.
• New Medical Data Enterprise. Advance the use of real-world experience (RWE) to better inform patient care and provide more efficient, robust, and potentially lower-cost ways to develop clinical data that can inform product review and promote innovation. The effort will cover a broad range of medical products, including drugs, biologics, and medical devices. The House committee bill would provide $60 million; the Senate committee bill would not provide any new funding.
• Growth and Transformation of Digital Health. FDA will work with stakeholders to establish a new risk-based regulatory paradigm for digital health technologies that would allow companies to: (1) market lower-risk products without FDA premarket review and (2) market higher-risk products following a streamlined FDA premarket review. The House committee bill would provide $40 million; the Senate committee bill would not provide any new funding.
• New Platform for Drug Development.  Rapidly advancing science in drug development requires FDA to have up-to-date scientific standards and assessment tools, as well as the ability to stimulate evolving methods, technologies and approaches. The House committee bill would provide $45 million; the Senate committee bill would provide $8.2 million.

Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.