Star Tribune: U.S. House passes 21st Century Cures Act
WASHINGTON – The U.S. House on Wednesday overwhelmingly passed a wide-ranging medical research bill designed to fund scientific innovations and cutting-edge therapies while also getting medical devices and drugs to market faster.
The 21st Century Cures Act covers everything from a "cancer moonshot" designed to cure that dreaded disease to money to address the nation's opioid addiction crisis to a precision medicine initiative.
It also outlines new, quicker ways of proving the safety and effectiveness of drugs and devices and funds the National Institutes of Health and the Food and Drug Administration.
The multibillion-dollar, 1,000-page bill took two years to negotiate with the last compromise coming just days before the House vote. The Obama administration supports the bill.
Rep. Fred Upton, R-Mich., one of the act's chief architects, called it a "giant leap on the path to cures.
The consensus in the 392-26 vote marked a contrast to the partisan battles that have consumed the legislative body in recent years.
"No family is untouched by disease," said Rep. John Kline, Minnesota Republican in the Second District.
"I was pleased we could come together to pass bipartisan legislation that aims to reduce the reach of life-altering diseases by reforming our approach to medical innovation, and ultimately saving and improving lives."
Democratic Rep. Rick Nolan pointed to the act's comprehensive approach.
"The bill provides substantial new funding for research into cancer and many other diseases, including $1 billion to supplement opioid abuse prevention and treatment activities; accelerates clinics trials and FDA approval of new drugs and provides a major new emphasis on providing more community mental health services," he said.
"Of course, there are still improvements that could have been made to the legislation; but this bill constitutes a real bipartisan effort to move medical research and health care delivery into the 21st century."
The medical device industry, which makes up a critical chunk of Minnesota's economy, welcomed the bill as a milestone.
"The package includes a number of important improvements to [the Food and Drug Administration's] medical device premarket program designed to increase the efficiency, predictability and transparency of the agency's review process," said Scott Whitaker, the CEO of the Advanced Medical Technology Association, the device industry trade group whose members include Medtronic, St. Jude Medical and other medical technology companies with major Minnesota ties.
Whitaker said the industry needs an "expedited pathway for breakthrough medical technologies."
Some patient advocates cautioned that the bill curtailed the scope of safety and effectiveness testing in ways that could eventually injure people.
"The legislation includes a grab bag of goodies for Big Pharma and medical device companies that would undermine requirements for ensuring safe and effective drugs and medical devices," Dr. Michael Carome of Public Citizen said.
But Republican Rep. Tom Emmer said the act was a "great step in our efforts to address the mental health and opioid crises plaguing this nation."
Democratic Rep. Betty McCollum called the bill "one of the few opportunities for bipartisan compromise."
The legislation now heads to the Senate where a vote is expected next week. Senate passage is likely, but a fiery speech opposing the bill by Sen. Elizabeth Warren, D-Mass., signaled that debate could be feisty.