By Jof Enriquez,
Follow me on Twitter @jofenriq
The U.S. House of Representatives overwhelmingly passed a compromise version of the 21st Century Cures Act to streamline drug and medical device approval, and to boost research and medical innovation. The landmark legislation is headed next week to the Senate, where approval is seen likely.
Rare bipartisan support in the House led to a 392-26 vote in favor of the $6.3-billion "Cures" act, a wide-ranging and ambitious collection of measures like a "cancer moonshot" and President Barack Obama's Precision Medicine Initiative. It also streamlines how the U.S. Food and Drug Administration (FDA) regulates drugs and devices, by introducing measures such as expedited reviews for breakthrough technologies and real-world evidence generation. The legislation allocates increased funding for FDA to implement regulatory changes, and for the National Institutes of Health’s (NIH) research initiatives, as well as $1 billion for opioid abuse treatment programs.
“We are on the cusp of something special — a once-in-a-generation opportunity to transform how we treat disease,” said Representative Fred Upton (R-Mich.), who led the House effort to pass the bill, reports STAT. “With today’s vote, we are taking a giant leap on the path to cures.”
AdvaMed, the medtech trade group, lauded the passage of the bill, which survived three years of debates and revisions.
"The package includes a number of important improvements to [FDA’s] medical device premarket program designed to increase the efficiency, predictability and transparency of the agency's review process," said AdvaMed CEO Scott Whitaker, according to the Star Tribune.
Detractors of the legislation fear the weakening of FDA's mandate to protect public safety from unproven drugs and medical devices. One point of contention is the acceptance of real-world data in expedited regulatory pathways, instead of rigorous clinical trials, as basis for regulatory approvals.
"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," said Dr. Michael Carome of Public Citizen, reports the Star Tribune.
U.S. Sen. Elizabeth Warren (D-Mass.), who has criticized the bill as a danger to the public that only serves corporate interests, is expected to lead the opposition at the Senate when it considers the measure next week.
Senators were previously split along party lines regarding the bill. However, disagreements over certain provisions and sources for funding were ironed out in the new version that passed in the House, and widespread public support for endeavors like cancer research means the Senate likely will pass the measure, most observers agree.
After clearing the Senate, the legislation is expected to be signed by President Obama, according to Fortune. President-elect Donald Trump, meanwhile, has yet to comment on the 21st Century Cures Act.