The Full Senate Position on FDA's FY 19 Appropriation

The Senate Appropriations committee proposed an increase of $159 million in BA spending for FDA in FY 19. Following this week’s vote, that is now the full Senate’s position:

• $88.5 million is for new medical product initiatives
• $59 million would pay for new opioid program initiatives, and
• $15.5 million would for food safety programs, notably for FSMA cooperative agreements with states, food import safety, food safety outbreaks, and testing antibiotic resistance in imported seafood.

Program increases total $163 million and there are $4 million of offsets elsewhere in the FDA budget.The Administration requested about $400 million for 10 new medical product initiatives. The House provided some level of funding for all of them, while the Senate proposed less funding in the aggregate, as well as funding fewer of the initiatives. Fuller analysis of the House's and the Senate’s responses to the Administration’s proposals are here and here.Here are the medical products initiatives in the Senate-passed bill:

• Promote Domestic Manufacturing. The House committee bill would provide $38.5 million; the Senate bill would provide $11.7 million.
  • New technologies have great potential to accelerate new, more targeted therapies, enhance product quality and bolster stability in the U.S. drug supply to meet domestic and global needs. These new manufacturing platforms may be especially important in the development of personalized medicines and innovations in cell– and gene-based therapies and vaccines.

• MedTech Manufacturing. The House committee bill would provide $12 million; the Senate bill would provide $6 million.
  • As medical devices become more complex ‒ and given the frequent modifications made to devices – spurring advanced manufacturing and creating a competitive marketplace for device quality is critical for both driving technological innovations and assuring patient safety. FDA is already working collaboratively with industry, patients, providers, and payers through the Medical Device Innovation Consortium to develop the parameters of this program.

• New Platform for Drug Development.  The House committee bill would provide $45 million; the Senate bill would provide $8.2 million.
  • Rapidly advancing science in drug development requires FDA to have up-to-date scientific standards and assessment tools, as well as evolving technologies, methods, and approaches. Without these tools, the Agency’s ability to support innovation and review applications will lag behind the latest science and inhibit innovation.

• Modernizing Generic Drug Development and Review. The House committee bill would provide $27 million; the Senate bill would provide $37.6 million.
  •  Create a new review platform that will significantly modernize generic drug review from a text-based to a data-based assessment with structured submissions and FDA assessments. This more automated system will improve clarity for generic sponsors, making initial reviews more efficient; decrease the risk of refuse-to-file letters; increase the rate of first-cycle approvals, and greatly increase overall efficiency

• FDA’s Oncology Center for Excellence and Investment and Innovation for Rare Diseases. 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.

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