Patient advocates love it, public-health groups hate it, and Senator Elizabeth Warren says it has been "hijacked." But what might the 21st Century Cures Act mean for medtech?
With the 21st Century Cures Act coming up for a vote in the U.S. House of Representatives today, the medtech industry could get some long-hoped for benefits.
It's been a long wait. The House passed its own version of the bill last year, but Senate Republicans wrangled with Democrats over the final language for months, striking a deal last Friday.
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The latest version of the $6.3 billion bill could benefit the industry by reducing medical device regulation. It contains provisions to:
- Streamline the FDA approval process for breakthrough devices.
- Allow evidence described in case histories, studies published in peer-reviewed journals, and data collected in other countries to suffice.
- Permit the secretary of Department of Health and Human Services to designate certain types of Class I and II devices to be exempt from the 510(k) approval process.
- Expedite the humanitarian review process and expand it to include diseases and conditions that affect twice as many patients, up to a total of 8,000.
- Streamline clinical trials by reducing duplicate efforts by HHS and FDA.
- Create a streamlined review process for drug-device combinations.
The bill also allots $500 million for FDA--much less than Democrats had sought--and $4.8 billion for the National Institutes of Health, down from the original bill's $8 billion.
The final draft of the legislation seeks to boost the efficiency, predictability and transparency of FDA's premarket approval process, according to a previous statement from Whitaker. The most significant change would build on existing resources within FDA to help create an expedited pathway for breakthrough medical technologies, Whitaker said.
"The innovation ecosystem that supports the development of these technologies is severely stressed," he added. "Policy improvements such as those contained in the revised 21st Century Cures legislative package will help strengthen that ecosystem and support the development of life-changing medical technology."
Approval by the House is not a done deal, although the pressure is on for Democrats who want to see it passed before President-elect Trump takes office and disassembles Obamacare.
Republicans demanded including funding sources for the bill, which would also provide $1 billion to states to fight the opioid epidemic, and $4.8 billion to further Vice President Joe Biden's cancer moonshot program, the BRAIN initiative to speed diagnosis and treatment of brain diseases like Alzheimer's, and the President Obama's Precision Medicine Initiative.
Democrats acquiesced, but are not united in their support. Massachusetts Senator Elizabeth Warren ripped the bill Monday, saying it had been "hijacked" by the pharmaceutical industry, according to a report by STAT News.
The bill has drawn kudos from patient-advocacy groups seeking cures for deadly diseases and debilitating conditions, and derision from public health groups concerned about the safety of devices and drugs that undergo expedited approvals. More than 1,300 lobbyists have sought lawmakers' attention on the bill, STAT noted.
"The House vote on Wednesday will be an extraordinary opportunity to help almost every American family," said House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Senate HELP Chairman Lamar Alexander (R-TN), in a joint statement. "What we have in the 21st Century Cures Act is an innovation game-changer, a transformational bill to bring our health infrastructure light years ahead to best match the incredible breakthroughs that are happening by the day."
Once the House votes, the Senate will take up the bill before the end of December, according to Senate Majority Leader Mitch McConnell (R-KY).
Nancy Crotti is a contributor to Qmed.
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