Health Care Business, March 23, 2016. A bipartisan Senate committee has approved three bills that could help get medical devices to patients sooner by creating a “breakthrough pathway” through the U.S. Food and Drug Administration, but not everyone is happy about the actions.
The Wall Street Journal, March 9, 2016. Patient-safety advocates, including the National Center for Health Research, warn that the bills would weaken the FDA’s ability to ensure devices’ safety.
If he were playing it safe, Dr. Vinay Prasad might be among the last to turn into a medical provocateur. Prasad’s outspokenness and willingness to criticize industrywide assumptions place him in the ranks of a small but influential group of physicians and researchers who are either having an impact on the way medicine is practiced in the United States, or tilting at windmills.
February 16, 2016 – FDA’s device center chief Jeff Shuren, in an interview with Inside Health Policy, highlighted the benefit a robust National Device Evaluation System could have in bolstering the agency’s ability to monitor devices in real-time to better inform the risk-benefit profile of approved products. Such a system, he said, could also help in the premarket approval phase to reduce the clinical trial burden on manufacturers and get products to market faster.
February 11, 2016 – Hospitals don’t have much to gain from the moonshot, at least in the short run. There are lot of other pressing, fixable problems with cancer care that the Obama administration’s effort won’t address.
January 14, 2016. New York Times. Federal investigators said Thursday that there were flaws in the way the Food and Drug Administration tracked drugs after they came to market, raising questions about the agency’s effectiveness as the country’s main drug overseer.