Morning Briefing
Summaries of health policy coverage from major news organizations
Despite Widespread Support For Bill To Overhaul FDA, Some Consumer Advocates Raise Concerns
The 21st Century Cures Act is a $6.3 billion piece of legislation that would be the biggest health reform bill since the Affordable Care Act. Proponents, including President Obama and Senate Majority Leader Mitch McConnell, say that the bill will help unlock cures for cancer, Alzheimer's and opioid addiction. Opponents, including Massachusetts Sen. Elizabeth Warren, say that the bill has been "hijacked" by the pharmaceutical industry. We speak to the co-chair of the National Physicians Alliance Food and Drug Administration聽Task Force about what the bill might mean for the FDA. (O'Keefe and Chakrabarti, 12/6)
Congressional lawmakers are championing the 21st聽Century Cures Act as a 鈥渨atershed moment鈥 that will go a long way toward helping patients, but some consumer advocates and academics warn the legislation contains a provision that may usher in a new era of lower approval standards. Here鈥檚 why: The bill聽requires the Food and Drug Administration to develop a program for evaluating the use of so-called 鈥渞eal world evidence鈥 for approving additional uses of medicines, as well as for any follow-up studies that may be required. (Silverman, 12/6)
The Senate is expected this week to clear the 鈥21st Century Cures鈥 package, a medical innovation bill that also includes provisions designed to make it easier for patients to access mental health treatment. Some of the bill鈥檚 supporters lament that the provisions wouldn鈥檛 increase federal funding for inpatient treatment, but there is widespread support for other items that would integrate mental health into primary care services, train new behavioral health providers and train law enforcement and the legal system to better deal with crime related to mental health problems. All of that would be less meaningful if Republicans roll back President Barack Obama鈥檚 health care law and people lose coverage, said Rep. Frank Pallone Jr. of New Jersey who, as ranking Democrat on the Energy and Commerce Committee, played a major role reaching a compromise on the mental health legislation. (Siddons, 12/6)
