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# FDA Justifies FY 2021 $6.2 Billion Budget Request
- URL: https://www.fdaweb.com/fda-justifies-fy-2021-6-2-billion-budget-request/
- Published: 2020-02-13T12:00:00.000Z
- Updated: 2026-09-14T16:02:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146087

In a 430-page [budget justification](https://www.fda.gov/media/135078/download?ref=fdaweb.com) for Congress, FDA commissioner **Stephen Hahn** says the agency’s request for $6.2 billion, an overall increase of $265.4 million compared to the FY 2020 enacted level (4.5% increase) will allow the agency to “invest in initiatives focused on the most urgent priorities as well as critically needed infrastructure.” He cites efforts to: 

- apply novel approaches to data management including artificial intelligence and other emerging technologies to drive the growth of the U.S. economy, foster development of safe medical devices, and make the food supply safer;
- support oversight of increasing numbers of FDA-regulated products containing cannabis-derived substances requiring FDA assessment or review;
- make the U.S. influenza vaccine supply more robust, secure, and nimble to combat seasonal influenza epidemics and potential influenza pandemics; and
- work closely with stakeholders to ensure that patients receive the highest quality of compounded drugs when they need them.

Among the many legislative proposals in the budget justification are ones to: 

- give FDA authority to publicly disclose a summary of any safety and/or effectiveness data and information pursuant to a determination that it is appropriate for public consideration of a specific issue;
- give the agency authority to require NDA, BLA, or ANDA applicants to submit a post-approval quality update to provide information or implement changes needed to ensure ongoing quality and, therefore, safety and efficacy of a product once approved and marketed;
- establish a voluntary alternative to the premarket notification (501(k)) pathway that would allow manufacturers of certain well-understood medical device types to rely on objective safety and performance criteria to demonstrate substantial equivalence, enabling FDA to help improve safety and performance and ensure new products can more easily reflect beneficial new advances; and
- permit the agency expedited access to devices that would otherwise be reviewed under the PMA or de novo classifications pathways if they are intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and address an unmet medical need using a two-step provisional and final approval process.