The BMJ, December 17. 2015. Dr. Diana Zuckerman from The National Center for Health Research shared, “There’s a world of difference between talking about approval standards in general and crafting specific legislative language. It is outrageous that FDA officials and regulated industry are sitting down to craft legislative language to give to congressional staff.”
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.
InsideHealthPolicy.com, March 7, 2016. While minority, patient and consumer groups pushed for more diversity in the clinical trial phase, Jocelyn Ulrich director of scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA), said matching demographic subgroups based on sex, age and race, specifically the African American and Hispanic populations, to disease prevalence would extend phase III clinical trials by 20 months or longer.
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.