Gottlieb welcomes furloughed FDA staffers back to work as he unveils new data projects

Scott Gottlieb FDA
Gottlieb unveiled several new projects aimed at harnessing real-world data. (FDA)

After a record 35-day government shutdown, Food and Drug Administration staffers were glad to be back at work on Monday, Commissioner Scott Gottlieb said. 

The FDA was hit particularly hard by the shutdown, with many furloughed workers and inspectors working unpaid. Gottlieb said the field force staffers, in addition to missing paychecks, racked up travel costs visiting food and device facilities. And while the FDA was able to offload their lodging and airfare costs, Gottlieb said these workers were still forced to use credit for other daily costs such as meals. 

“This has been a hard episode for the agency, but I think as we said from the outset … the agency held fast to its mission,” said Gottlieb during his keynote address at a Bipartisan Policy Center event on the applications of real-world data and evidence.

Conference

2019 Drug Pricing and Reimbursement Stakeholder Summit

Given federal and state pricing requirements arising, press releases from industry leading pharma companies, and the new Drug Transparency Act, it is important to stay ahead of news headlines and anticipated requirements in order to hit company profit targets, maintain value to patients and promote strong, multi-beneficial relationships with manufacturers, providers, payers, and all other stakeholders within the pricing landscape. This conference will provide a platform to encourage a dialogue among such stakeholders in the pricing and reimbursement space so that they can receive a current state of the union regarding regulatory changes while providing actionable insights in anticipation of the future.

RELATED: In midst of government shutdown, former FDA commissioners argue for agency to split from HHS 

During the event, Gottlieb announced several projects the agency is undertaking to harness real-world evidence and data, particularly to boost access to and efficacy of clinical trials. 

This year, Gottlieb said, the FDA intends to convene a working group to develop new ways to make oversight of clinical trials more efficient using the latest technologies, including remote monitoring. The goal, he said, is to develop universal data standards that allow clinical trials to more effectively adapt to changing tech and the new regulations that often follow. 

“To take one example: remote- and risk-based monitoring can provide better regulatory oversight,” Gottlieb said. “These approaches may lower development costs, and enable more trial sites to answer important scientific and clinical questions as a way to improve patient care.” 

Meeting patients where they are in a clinical trial is an FDA priority, Gottlieb said. As such, the agency convened a separate working group to focus on building guidance that can be used to launch decentralized trials. The results of those meetings will also be released soon. 

RELATED: FDA needs to fill data gaps as it looks to increase access to targeted therapies 

Gottlieb said the FDA is also harnessing real-world data through its INFORMED (Information Exchange and Data Transformation) program. That project uses analytics to determine the efficacy of drug labeling changes that can push providers to change behavior, he said. 

The program also uses machine learning and artificial intelligence in this work, he said. This year, the FDA expects INFORMED to lead the charge to build an FDA curriculum on these topics in partnership with clinical experts and academics. 

This will go hand-in-hand with a future fellowship in AI, which aims to use the tech to build new regulatory science tools, Gottlieb said. 

“By engaging with multiple stakeholders through collaborative forums and working closely with our agency partners … [the FDA] can help promote more transparent standards for curating data, interoperability and RWE generation that can help ensure that every American patient—no matter where they live, or what their insurance coverage is—benefits from the full potential of these technologies to make our healthcare system safer, smarter, and more patient-focused,” Gottlieb said.

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