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# In Era of Government Cuts, FDA Gets $308 Million Boost
- URL: https://www.fdaweb.com/in-era-of-government-cuts-fda-gets-308-million-boost/
- Published: 2018-05-18T12:00:00.000Z
- Updated: 2026-09-15T00:06:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141479

While the Trump Administration has its sights on slashing program areas at various federal agencies, FDA continues to get strong support on Capitol Hill for increased funding for new and existing program areas. On 5/16, a House Appropriations Committee mark-up for FDA’s fiscal year 2019 funding increased its budget authority to $3.108 billion, a $308 million increase (11%) over its 2018 base of $2.8 billion. The boosts appear to reflect the effectiveness of lobbying by both the Alliance for a Stronger FDA and FDA commissioner **Scott Gottlieb**.

According to an Alliance for a Stronger FDA [analysis](https://strengthenfda.org/2018/05/18/advocacy-at-a-glance-316/?ref=fdaweb.com), the committee has said that the entire $308 million increase will go to medical product safety initiatives — a number of programs and initiatives that were in the President’s request that should expand FDA’s programmatic reach into regulated industry and growing new industries for future regulation. For example, $60 million would be allocated for a New Medical Data Enterprise that will advance the use of real-world experience data 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 group says.

Another investment approved by the mark-up would provide $50 million for a New Platform for Drug Development, including a $5 million 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,” the Alliance notes. “Without these tools, the agency’s ability to support innovation and review applications will lag behind the latest science and inhibit innovation.”

Under the measure, $40 million would be provided for the Growth and Transformation of Digital Health. This effort would see FDA 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,” according to the Alliance. “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.”

Additionally, the increased funding would provide $38 million to promote new technologies to accelerate new, more targeted therapies, enhance product quality and bolster stability in the U.S. drug supply. “These new manufacturing platforms may be especially important in the development of personalized medicines and innovations in cell- and gene-based therapies and vaccines,” the Alliance says. And $12 million would go to expanding “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,” it adds.