The U.S. Congress has passed sweeping bipartisan health care legislation intended to expand medical research and speed up approval of new drugs and medical devices.
The $6.3 billion bill, called the 21st Century Cures Act, is a complex grab bag of initiatives amounting to nearly 1,000 pages that President Barack Obama is expected to sign into law.
In a statement released Wednesday, Obama signaled his support for the bill.
“We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimer’s, and helping people seeking treatment for opioid addiction finally get the help they need,” he said. “This bill will make a big difference, and I look forward to signing it as soon as it reaches my desk.”
The Senate passed the bill today by a vote of 94-5, and the House passed an almost identical version on Dec. 1, at 392-26. […]
A number of provisions in the 21st Century Cures Act also are aimed at swift approval of new drugs and devices. These would allow the U.S. Food and Drug Administration to:
- Rely on data summaries and “real world evidence” instead of hard clinical trial evidence when weighing the approval of existing drugs for new uses. Right now, for example, the FDA now must consider “patient experience” and anecdotal data in its review process.
- Use a “limited population” approval pathway for new antibiotics that would rely on a risk-benefit analysis weighing the needs of patients facing severe and untreatable infections against the possible harms to them.
- Expand its programs for expedited approval of breakthrough medical technologies for patients with life-threatening diseases that have limited treatment options.
Many have applauded the new measures, but critics say these the moves could raise the risk of harmful treatments getting to the marketplace.
“The FDA over all these decades has developed a way to know what products work and which ones don’t, but in the last decade they have been pushed to lower those standards,” Diana Zuckerman, president of the National Center for Health Research, told U.S. News & World Report. “With this bill, they’d lower them even more.” […]