The Food and Drug Administration is kicking off a new approach to drug and device regulation that will use computer models and virtual patients to test cutting-edge products and speed up the regulatory approval process.
The use of computer modeling is one of several ways the agency plans to modernize its regulatory process through provisions in the 21st Century Cures Act. Last week, the FDA released a work plan (PDF) detailing how it plans to meet requirements of the law by accelerating medical product innovation.
"FDA is working hard to maximize the authorities & resources Congress granted us to advance medical innovation for patients."--@SGottliebFDA— U.S. FDA (@US_FDA) July 7, 2017
FDA Commissioner Scott Gottlieb highlighted computer modeling as a key feature of the agency’s forthcoming Innovation Initiative. In a blog post, he outlined FDA’s move toward “in silico clinical trials” that use computer models and simulations to evaluate new devices and drugs.
.@US_FDA will soon unveil Innovation Initiative aimed at making sure our regulatory processes are modern and efficient— Scott Gottlieb, M.D. (@SGottliebFDA) July 7, 2017
The technology-based approach, which will require continued investment in “high-performance computing,” will be particularly beneficial for developing individualized medications by incorporating genomic data into computer models. It can also advance new therapies for rare diseases by tapping into rich historical data.
“Right now, FDA is collaborating with scientists to develop such natural history models in Parkinson’s disease, Huntington’s disease, Alzheimer’s disease and muscular dystrophy,” Gottlieb wrote. “An important objective of modeling and simulation is to better evaluate the behavior of new treatments in rare disease populations that are inherently hard to study due to their small size.”
The FDA’s Center for Devices and Radiological Health also plans to develop a digital library of models and virtual patients to test new devices.
Gottlieb’s announcement comes nearly a month after he revealed a new Digital Health Innovation Plan, an approach that was thoroughly praised by the industry. The FDA’s Bakul Patel has also said he is already hiring for key positions to fill the CDRH’s new central digital health unit.
Although the 21st Century Cures Act requires the FDA to develop new innovative approaches to drug and device regulation, many saw Gottlieb as a champion of deregulation when he was nominated to the post, and someone willing to push the agency forward despite his close industry ties.