> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Budget Increase to Bolster Generics, Real World Data: Gottlieb
- URL: https://www.fdaweb.com/budget-increase-to-bolster-generics-real-world-data-gottlieb/
- Published: 2018-04-24T12:00:00.000Z
- Updated: 2026-09-15T00:00:43.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141289

FDA commissioner **Scott Gottlieb** [told Senate appropriators 4/24](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605539.htm?ref=fdaweb.com) that the Trump Administration’s proposed fiscal year 2019 budget increase of $663 million (13%) over last fiscal year will provide the agency with new resources to make “significant investments in advancing critical areas of science, domestic technology and public health. Specifically, he said the $473 million in budget authority and $190 million in user fees increases will go a long way to “modernize our generic drug platform... The first element of our proposal will help make the approval of new generic drugs more efficient, by establishing a structured application. We believe a structured application, which allows key sections of the generic drug file to be captured in a structured template, will speed the review of the application and cut down on the number of review cycles that applications must undergo, thereby reducing generic drug development timelines.”

The second element will be focused at promoting a wider use of existing generic drugs by examining ways to keep generic drug labels up-to-date with the latest information about safety and benefits. Gottlieb noted that brand makers are typically required to update labels with new information and generics subsequently follow suit, but when brand companies “voluntarily withdraw their marketing applications and therefore stop updating their labeling, FDA loses a mechanism to update generic labels... The number of generic drugs that reference discontinued or withdrawn brand drugs essentially comprise about one-fifth of the total number of reference-listed drugs. This covers about 460 unique active ingredients.” Gottlieb told the appropriators that FDA needs the requested resources to “assume more responsibility to help bring these drug labels up-to-date. I believe that if we take on this role; it can promote more widespread use of generic medicines.”

Additionally, Gottlieb said the budget proposal would improve the use of real world evidence in regulatory decisions. “We seek to expand new and existing active surveillance systems to enhance our real-time understanding of medial product performance by broadening our use of healthcare data to better take advantage of data available from electronic health records,” he said. “First, the data must be high quality and ‘inter-operable,’ meaning that the data can be collected in one system, but used in many systems to inform patient care. Second, we must work toward better integration of clinical care and clinical research. The most informative and efficient way of developing medical products is to study them and how and where they will be used. Finally, we must support development of tools that will allow these data to be properly used to inform our understanding of not only medical product safety, but also its efficacy.” The budget request includes $100 million to advance the use of real-world data.