Medical Device and Diagnostic Industry, September 17, 2015. By nominating cardiologist Robert M. Califf to be FDA’s next commissioner, the Obama Administration has taken a giant step away from the agency’s traditional avoidance of even the suspicion of coziness with the industries it regulates.
Medpage Today. September 16, 2015. The nomination of Robert Califf, MD, as FDA commissioner is getting good reviews from most health policy and cardiology experts. One area that might cause controversy with Califf’s nomination is his ties to the pharmaceutical industry.
Boston Globe, September 14, 2015. Not everyone is pleased with Milken’s behind-the-scenes advocacy. While supporters say the Cures Act, a version of which was passed by the House in July, would make it cheaper and faster to get cutting-edge drugs and medical devices to patients, critics warn that it would create dangerous regulatory shortcuts.
Our patient booklet, DCIS: What You Need to Know, helps women diagnosed with DCIS understand the difference between DCIS and Stage 1 breast cancer, and discuss treatment options with their doctor. It was funded by a grant from the DC Cancer Consortium through the Department of Health, Government of the District of Columbia, with additional support from the Jacob and Hilda Blaustein Foundation.
The bill’s laundry list of provisions that tweak the process for approving new drugs or devices have raised significant concern from industry watchdogs and physicians who say the legislation is aimed more at helping drug and device companies than patients.
Lawmakers in the House easily passed the 21st Century Cures Act today, a big step toward once again shaking up the legal framework built to guide drug development in the U.S. while significantly boosting the amount of funding that flows to the NIH. Consumer advocates, though, see the new development regulations as a recipe for unleashing drugs and devices that would later prove dangerous and unhelpful.