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.
I look forward to being outside Building 1 today to greet ALL my colleagues as we return to our posts TOGETHER. I know there will be additional challenges ahead as we catch up on missed work and deadlines. I’ll support you in all of these efforts as we forge ahead as ONE #FDA pic.twitter.com/0zJSmNXU9o— Scott Gottlieb, M.D. (@SGottliebFDA) January 28, 2019
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.
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.