House Recommends Major Increase in BA Funding

The House committee’s recommendation is for a $308 million increase in BA funding for medical product safety, incorporating a number of programs and initiatives that were in the President’s request (see text pages 6 to 10 here). Note that the programs described below total about $289 million, so part of the House’s intended increase is not yet accounted for.

• $30,000,000 to assist FDA confront the opioid crisis (in addition to monies in the FY 18 appropriations Act)
• $38,500,000 to promote domestic manufacturing
  • 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. Improved manufacturing technology can produce substantial return-on-investment.
• $12,000,000 for a new domestic drug industry
  • 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.
• $12,000,000 for medtech manufacturing
  • 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.
• $60,000,000 for new medical data enterprise
  • 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.
• $40,000,000 for the growth and transformation of digital health
  • FDA to work with stakeholder 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. Two benefits of an improved regulatory framework would involve better access to postmarket data and the opportunity to focus more on the cybersecurity issues inherent in digital health.
• $50,000,000 for a new platform for drug development, including a $5,000,000 increase for FDA’s Oncology Center for Excellence
  • 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.
• $27,000,000 for modernizing generic drug development and review
  •  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
• $20,000,000 for investment and innovation for rare diseases
  • FDA will stimulate medical product development for rare diseases by expanding and enhancing the understanding of rare diseases and the research and drug development processes in this space.

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