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# FDA Medical Product Programs Benefit in Budget Request
- URL: https://www.fdaweb.com/fda-medical-product-programs-benefit-in-budget-request/
- Published: 2019-03-18T12:00:00.000Z
- Updated: 2026-09-15T01:13:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143636

FDA’s medical product programs appear to benefit most from the Trump Administration’s proposed 7% boost ($419 million) to the agency’s 2020 budget ([see earlier story](https://www.fdaweb.com/trump-admin-proposes-419-million-budget-boost-for-fda/)). According to a just-released budget justification document for FDA, the budget request for medical product safety- and availability-related programs totals $3.8 billion, an increase of $428 million above 2019 levels. Subject to congressional agreement, some of the notable program areas identified in the justification document are: 

- **Promote Domestic Manufacturing:** $38.5 million to advance modern drug and biological product manufacturing technologies, and develop efficient regulatory pathways. These technologies have potential to accelerate new, more targeted therapies, enhance product quality, allow the vaccine supply to be more easily ramped up on short notice, and bolster stability in the U.S. drug supply to meet domestic and global needs. New manufacturing platforms contribute to development of personalized medicines and may help reduce the cost and uncertainty of adopting new manufacturing technologies.
- **Modernize Generic Drug Reviews:** The budget includes $27 million to continue to modernize generic drug development by enhancing review and approval efficiency, and by enabling more consistent regulatory decision making. This proposal would expand current efforts to streamline and automate the drug quality section reviews to include other disciplines engaged in generic drug application assessments and lead to faster generic drug approval.
- **Opioids:** $55 million to support ongoing efforts to address the opioid crisis, as well as support existing investments and additional lab needs for the International Mail Facilities initiative by increasing field and Center operational capacity to review up to 100,000 packages annually.
- **Compounding:** $13.5 million to “catalyze” development of policies and regulations for the outsourcing facilities, including advancement of the list of bulk drug substances that outsourcing facilities may use in compounding and current GMP guidance and regulation specific to outsourcing facilities.
- **Advance the outsourcing facility sector for compounded products:** $12 million to create a “Center of Excellence on Compounding for Outsourcing Facilities” which would 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.
- **Advance Medical Device Manufacturing and Quality:** $12 million to establish a voluntary program for device manufacturers to receive certification for meeting objective manufacturing and product quality criteria. FDA intends to recognize third-party certifiers and offer regulatory incentives for those manufacturers who receive certification demonstrating their quality capability to increase manufacturing innovation, and accelerate availability of high-quality devices.
- **New Medical Data Enterprise:** $60 million to advance the use of real-world evidence to improve human and animal health and support pre-market evaluation and post-market safety. This capability would allow FDA to conduct near-real-time evidence evaluation down to the level of individual electronic health records for at least 10 million individuals in U.S. healthcare settings.
- **Transform Medical Device Safety, Cybersecurity, Review, and Innovation:** $55 million to build an integrated knowledge management system and portal for medical devices using information technology systems with secure cloud-based data storage that would enable safety issues to be monitored along the total life cycle of the device from bench testing to premarket clinical trials to post-market adverse events and real-world evidence.
- **Create a New Platform for How the Agency More Efficiently Develops and Validates Modern Science-Based Principles for New Drug Development:** $50 million to build a knowledge management system and portal to apply cutting edge science to advance drug development and review as well as to support a new model for team-based product review and collaboration within the FDA Oncology Center of Excellence
- **Stimulate Innovation of Medical Products Targeted to Rare Diseases:** $20 million to develop clinical trial networks to create an understanding of the natural history and clinical outcomes of rare diseases.
- **21st Century Cures — FDA Innovation Account:** $15 million to help FDA implement provisions to accelerate medical product innovation, reduce regulatory burden, increase efforts for critical scientific and methodological research, and increase the involvement of patients and their perspectives in research and the medical product development process.
- **Medical Countermeasures:** The budget includes $7 million for FDA review and regulatory science capacity to facilitate the development and availability of medical countermeasures to respond to chemical, biological, radiological, nuclear, and emerging infectious disease threats.