Despite Widespread Support For Bill To Overhaul FDA, Some Consumer Advocates Raise Concerns
The 21st Century Cures Act has been hailed by Democrats and Republican alike as a way to advance treatments for some of the nation's biggest health concerns, such as Alzheimer's disease, cancer and opioid addiction. But some consumer advocates are concerned that it may lower safety standards.
WBUR:
How The 21st Century Cures Act Could Affect The FDA
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 Task Force about what the bill might mean for the FDA. (O'Keefe and Chakrabarti, 12/6)
Stat:
Will 21st Century Cures Lower Standards And Harm Patients?
Congressional lawmakers are championing the 21st Century Cures Act as a “watershed moment” 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’s why: The bill requires the Food and Drug Administration to develop a program for evaluating the use of so-called “real world evidence” for approving additional uses of medicines, as well as for any follow-up studies that may be required. (Silverman, 12/6)
Roll Call:
Obamacare Repeal Could Undercut Mental Health Effort
The Senate is expected this week to clear the “21st Century Cures” 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’s supporters lament that the provisions wouldn’t 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’s 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)
