By Dennis Thompson
TUESDAY, Dec. 13, 2016 (HealthDay News) -- President Barack Obama on Tuesday signed into law 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.
With the new legislation, "We are bringing to reality the possibility of new breakthroughs to some of the greatest health challenges of our time," Obama said in a Tuesday afternoon signing ceremony at the White House.
The Senate passed the bill on Dec. 7 by a vote of 94-5, and the House passed an almost identical version on Dec. 1, at 392-26.
Obama said almost all Americans have been touched by losses due to cancer, mental illness and other conditions targeted by the new law. He mentioned his own mother, "who died of cancer when she was two and a half years younger than I am today."
Passage of the new law, is a way to "honor those we have lost in this way and to know that we may be able to prevent other families from feeling that same loss," Obama said. "I'm confident this will lead to better years and better lives for millions of Americans. "
The 21st Century Cures Act contains $4.8 billion in spending over 10 years for new research at the National Institutes of Health, including:
- $1.8 billion for the cancer research "moonshot" championed by Vice President Joe Biden.
- $1.56 billion for the BRAIN Initiative, a project to create new technologies that will allow for comprehensive mapping of the human brain.
- $1.4 billion for the Precision Medicine Initiative, a project supported by Obama to collect genetic data on one million American volunteers that will be used to help develop new treatments.
The legislation authorizes the NIH to finance high-risk, high-reward research using special procurement procedures, rather than through conventional grants and contracts, The New York Times reported. The agency also will establish "Eureka prize" competitions to advance medical research.
New positions at the U.S. Department of Health and Human Services will be established to coordinate mental health and substance abuse research and treatment.
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.
Numerous medical associations and advocacy groups have praised the new legislation, including the American Society for Clinical Oncology, the American Society of Human Genetics, the Coalition to Stop Opioid Overdose, the American Psychological Association, the American Psychiatric Association and the American Heart Association.
"This landmark legislation will spur development and delivery of promising new treatments for patients," ASCO President Dr. Daniel Hayes said in a statement.
But watchdog group Public Citizen decried the law, claiming it gives too much leeway to pharmaceutical and medical device makers.
"It is sorely disappointing that Congress gave Big Pharma and the medical device industry an early Christmas present by passing the 21st Century Cures Act," said Dr. Michael Carome, director of the organization's Health Research Group.
"This gift -- which 1,300 lobbyists, mostly from pharmaceutical companies, helped sell -- comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices," Carome said in a statement.