Congress Shouldn’t Pass The 21st Century Cures Act In A Summer Rush - By Paul Brown, Tracy Rupp, and Steven Findlay, Health Affairs July 11, 2016 The full Senate may in the next few days consider companion legislation to the 21st Century Cures Act that passed the House last year. The legislation—currently 19 separate … Continue reading
Faster Drug Approval: Winners and Losers - By Kristen Fischer, HealthZette July 1, 2016 […] Recently, due to calls for novel treatments that move faster from the (lab) bench to the bedside, a legislative effort is attempting to speed up that process. The 21st Century Cures Act would … Continue reading
Republicans seize on reports critiquing FDA to push for agency reforms - Sheila Kaplan, STAT News June 15, 2016 Has Congress’s watchdog agency just given Tennessee Senator Lamar Alexander the ammunition he needs to push a stalled biomedical reform through the Senate? The Government Accountability Office on Wednesday issued two critical reports … Continue reading
Why we shouldn’t trade a weakened FDA for more medical research funds - By Ed Silverman, STAT News May 17, 2016 In a quest to bring new medical products to Americans, Congress is considering a grand bargain. Legislation passed last year by the House would provide billions more dollars for medical research and … Continue reading
FDA to shift clinical evidence for medical devices toward postmarket - Medical Design Technology, April 4, 2016. The National Center for Health Research expresses that Advancing Breakthrough Devices for Patients Act of 2015 encourages companies to get medical products on the market quickly as opposed to focusing on patient safety and product efficiency. Continue reading
US device industry and FDA “colluded” on legislation to weaken regulatory oversight - 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.” Continue reading
The 21st Century Cures Act could be a harmful step backward - November 19, 2015. The Washington Post. Precision medicine is the next big thing in health care, and it’s also one of the few health goals that Congress and the White House agree on. But while we await treatments targeting the precise genetic makeups of individuals and diseases, medical researchers still are not paying enough attention to the most important kinds of differences among patients: those of sex, age and race. Continue reading
Speeding Ineffective and Unsafe Treatments to Market in the Name of Patients? Not So Fast - Huffington Post, July 13, 2015. The Executive Director of Breast Cancer Action explains why medical experts oppose a bill to speed up Food and Drug Administration (FDA) approvals. Continue reading