FY 19 Funding: House and Senate Proposals

FDA has requested FY 19 funding for nine new medical product initiatives. Here is a description of each and their status under the House and Senate appropriations committee bills.

• Promote Domestic Manufacturing. The House committee bill would provide $38.5 million; the Senate committee 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.

• New Domestic Drug Industry. The House committee bill would provide $12 million; the Senate committee would not provide any new funding.
  • With these resources, 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.

• MedTech Manufacturing. The House committee bill would provide $12 million; the Senate committee 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 Medical Data Enterprise. The House committee bill would provide $60 million; the Senate committee bill would not provide any new funding.
  • Advance the use of real-world experience 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.

• Growth and Transformation of Digital Health. The House committee bill would provide $40 million; the Senate committee bill would not provide any new funding.
  • FDA will work with stakeholders to establish a new risk-based regulatory paradigm for digital health technologies that would allow companies to market lower-risk products without FDA premarket review and market higher-risk products following a streamlined FDA premarket review. This should provide a framework for better access to postmarket data and the opportunity to focus more on the cybersecurity issues inherent in digital health.

• New Platform for Drug Development.  The House committee bill would provide $45 million; the Senate committee 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 committee 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 and decreasing the risk of refuse-to-file letters, increasing the rate of first-cycle approvals, and greatly increasing 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.