FDA outlines plans for $400M budget boost

FDA Commissioner Scott Gottlieb Tuesday released a statement outlining how the agency plans to spend the roughly $400 million FY19 budget increase the Trump administration has requested.

The funds would be used to develop regulatory standards that are needed to advance continuous manufacturing of small molecule and biologic drugs, Gottlieb said. They would also be deployed to facilitating the use of real-world evidence, in both premarket and postmarket settings.

Gottlieb also said the additional funds would be used to “develop clinical trial networks to create an understanding of the natural history (such as individual patient experiences and progression of symptoms) and clinical outcomes of rare diseases.”

FDA also plans to use the funds to build a knowledge management system that is intended to increase the consistency of regulatory decisions about drugs, and speed drug reviews.

Other priorities for the funding boost include developing a regulatory framework that speeds the creation of “outsourcing” facilities that compound drug products on a large scale in conformance with good manufacturing practices, and streamlining processes for submitting and reviewing generic drug applications.

The White House budget request is the first step in the lengthy congressional appropriations process. Congress will scrutinize the request over the coming months, and is likely to make substantial changes in the final budget.