The Health Affairs Blog, a vehicle for commentary on health policy and issues, recently wrote about how the Cures Act and FDA Draft Guidance suggest flexibility on communication of real-world drug impacts.
The post was authored by Dr. Peter Neumann and Elle Pope. Neumann is Director of the Center for the Evaluation of Value and Risk in Health at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center, and Professor of Medicine at Tufts University School of Medicine. Pope is a research assistant at the Center for the Evaluation of Value and Risk in Health at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center.
“Whether the Cures Act and the new draft guidance will lead to more drug company communications around real-world impacts remains to be seen, though this would seem likely,” Neumann and Pope wrote. “The new administration has stated generally that they will work to eliminate 'red tape' at the FDA, which may embolden companies and lead FDA to take a relatively 'hands-off' approach on the matter.”