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# Gottlieb Touts 13% Budget Boost for FDA at Hearing
- URL: https://www.fdaweb.com/gottlieb-touts-13-budget-boost-for-fda-at-hearing/
- Published: 2018-04-18T12:00:00.000Z
- Updated: 2026-09-14T23:59:45.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141252

FDA commissioner **Scott Gottlieb** told Congress 4/18 that a proposed fiscal year 2019 budget increase of $663 million (13%) over last fiscal year will allow the agency to sustain its current work while adding resources for fostering innovation and competition to bring better and more affordable products to market, combatting the opioid epidemic, and implementing the 21st Century Cures Act. Overall, Gottlieb told a House Appropriation hearing that the budget requests $5.8 billion in total resources for the agency.

One of the initiatives new resources would promote is advanced manufacturing technologies, such as continuous manufacturing, which “can improve the agility, flexibility, cost and robustness of drug and biologic manufacturing processes,” Gottlieb said in his testimony. “For example, continuous manufacturing has the potential to help address and eliminate drug shortages and reduce recalls related to problems with product or facility quality. Further, with continuous manufacturing platforms for biologics, vaccine manufacturing could be ramped up on short notice, and vaccines themselves adapted over a shorter time period to address infectious diseases, such as the flu. This would help address the challenge we face annually with the flu season. As a result of the long manufacturing cycle required when using traditional egg based manufacturing technologies, manufacturers must select the flu strain six months prior to the flu season. By reducing the amount of time it takes to ramp up manufacturing, we can start manufacturing closer to the start of flu season to minimize or eliminate the matching issues we face, to varying degrees, each year and increase the efficacy of the flu vaccine.”

Asked by Appropriations Subcommittee chair **Robert Aderholt** (R-AL) whether manufacturers have made any advances to improve their manufacturing technology, Gottlieb said the fundamental issue is that drug companies are “reluctant to innovate and introduce a lot of new technology for fear that it will introduce uncertainty with how FDA will embrace changes in manufacturing... Additional regulatory principles and tools to help manufacturers implement and assess these platforms could accelerate their adoption. It would give manufacturers greater certainty that products developed through continuous manufacturing can be efficiently reviewed and gain market entry.”

Gottlieb acknowledged that moving to continuous manufacturing won’t come easy. Based on the agency’s ability to put out guidance, to train review staff, to train its inspectorate and to try to work in public/private partnerships with industry to help them convert over to these new technologies, “it is going to be a slow migration,” he said.

Another top initiative in the budget is advancing real time post-market safety monitoring. Gottlieb said the agency wants to move beyond its Sentinel system that evaluates claims data and to develop real time monitoring of health records under an active surveillance system. Also, a “knowledge management system” is desired that would work “across the whole continuum of medical products to be able to capture and query our own precedent. These can be transformational types of infrastructure changes for the agency on a data and qualitative side,” he said.

Gottlieb also said that a new policy office will be set up in CDER “that will distill and align regulatory, clinical and scientific reasoning of review division to promote policy transparency and consistency. And we will be converting more of that information into hundreds of new disease-focused documents once these efforts are fully engaged... These guidances will outline clear and concise and up to date development guidelines as a way to foster innovation.

“Among some of the areas we are working on,” he continued, “are new guidances to layout modern criteria for developing drugs targeted to ulcerative colitis, rare pediatric cancers, pediatric HIV and serious blood disorders.” The guidances will focus on the most effective ways to provide safety and efficacy. “For example, the guidance on blood disorders will allow drug developers to reduce the use of animal testing and will outline ways to measure benefit that may permit more efficient development programs and earlier approvals,” Gottlieb said.