21st Century Cures Act reboot keeps controversial changes for FDA
Skip to main content
Sister Publication Links
  • Modern Healthcare Metrics
MDHC_Logotype_white
Subscribe
  • Subscribe
  • Register
  • Login
  • News
    • This Week's News
    • Providers
    • Insurance
    • Government
    • Finance
    • Technology
    • Safety & Quality
    • People
    • Regional News
    • Digital Edition
    • MACPAC thinks HHS needs new measures for Medicaid payment errors
      CMS to repay hospitals for doctor's visits
      Community Health Systems' CFO to retire at end of year
      Chart reviews boost Medicare Advantage payments by $6.7 billion, OIG finds
    • HealthPartners sheds more than 400 jobs across three rounds of cuts
      Kaiser Permanente seeks to address trauma in 25,000 schools by 2023
      KPC Group misses key deadline on Verity hospitals purchase
      Not-for-profit hospitals stabilized by Medicare pay raise, DSH cut delays
    • Michigan Blues makes deals with seven health organizations aiming to bend cost curve
      ACA exchange enrollment lags as deadline nears
      Plan members unlikely to benefit from Supreme Court risk corridor battle
      Joan Budden
      Q&A: Priority Health CEO eager to share best practices with Total Health Care
    • CMS to repay hospitals for doctor's visits
      Capitol Building with pills
      Week Ahead: House to vote on drug bill; SCOTUS hears risk-corridor case
      MedPAC thinks hospice payments are too high
      MedPAC says ambulatory surgical centers don't need a pay raise
    • Analysts to CommonSpirit Health: Show us the savings
      Smallest hospitals saw biggest earnings gains last month
      Sutter Health postpones financial filing
      doctor helping patient stock image Sandoz
      Sponsored Content Provided By Sandoz
      As hospital executives look to reduce costs, biosimilars offer a compelling option
    • astronaut
      Astronauts developed bloodstream issues in space
      Sponsored Content Provided By ABM Healthcare
      Protecting and Maintaining Medical Devices
      human hand robotic hand stock image
      Sponsored Content Provided By Deloitte
      The Health System of the Future: How Digital Health Technology is Transforming Care
      EHR
      EHR vendors most in-use throughout Medicare incentive program
    • Hospitals need more than HCAHPS to measure patient experience, report says
      Promising greater safety, a tiny widget creates chaos for tube feeders
      IHI releases principles for improving patient safety measures
      MRIs of dense breasts find more cancer but also false alarms
    • Community Health Systems' CFO to retire at end of year
      Kaiser Permanente names Gregory Adams CEO
      Google Health hires AliveCor's chief medical officer
      Trinity Health appoints new COO: Ben Carter
    • Midwest
    • Northeast
    • South
    • West
  • Special Features
    • Best Practices
    • InDepth Special Reports
    • Innovations
    • Chest x-ray from a patient with a vaping-related lung injury
      Vaping-related cases lead to care guidelines from Intermountain
      Arkansas Children’s was a founding partner in Solutions for Patient Safety.
      Children's hospitals collaborate rather than compete on patient safety
      Peer recovery specialists at St. Barnabas Medical Center work with nurse Brenna Zarra.
      Peer recovery helping patients with addiction seek treatment
      UNC Health Care trains staff to treat dementia patients
    • Linda Kenney
      Patient advocate recalls two medical errors that nearly killed her
      Doctors and nurse with patient
      20 years after 'To Err is Human,' hospital care quality measures are still of little use
      Dr. Christine Cassel
      To err is human. That’s still true 20 years later, but some solutions to the problem aren’t helping
      Leah Binder, CEO of the Leapfrog Group, with her grandmother, Estelle Greifer.
      With no national reporting system, volume of medical errors is still unknown
    • Randy Oostra, CEO of ProMedica
      HCR ManorCare deal laid foundation for ProMedica’s growth
      Advanced ICU Care
      Telemedicine helps rural hospitals meet intensivist shortage
      Paging Dr. Robot: Artificial intelligence moves into care
      A child being screened for vision problems using a smartphone.
      App screens kids for eye problems before they can talk
  • Transformation
    • Patients
    • Operations
    • Care Delivery
    • Payment
    • ProMedica doubles down on social needs data analysis
      Amazon taps first pharmacy for Alexa Rx management
      Trump administration unveils new price transparency rules
      A child being screened for vision problems using a smartphone.
      App screens kids for eye problems before they can talk
    • Health systems weigh return on investment as they ramp up tech
      VA dives into artificial intelligence R&D
      Home health to pare down therapy services, up telehealth offerings
      Amazon launches medical transcription service
    • Chest x-ray from a patient with a vaping-related lung injury
      Vaping-related cases lead to care guidelines from Intermountain
      Advanced ICU Care
      Telemedicine helps rural hospitals meet intensivist shortage
      Peer recovery specialists at St. Barnabas Medical Center work with nurse Brenna Zarra.
      Peer recovery helping patients with addiction seek treatment
      UNC Health Care trains staff to treat dementia patients
    • CMS to repay hospitals for doctor's visits
      Chart reviews boost Medicare Advantage payments by $6.7 billion, OIG finds
      Value-based pay still struggles to improve costs, quality
      Hospitals sue HHS over negotiated price disclosure rule
  • Data/Lists
    • Rankings/Lists
    • Data Points
    • Modern Healthcare Metrics
  • Op-Ed
    • Bold Moves
    • Breaking Bias
    • Commentaries
    • Letters
    • Vital Signs Blog
    • From the Editor
    • Randy Oostra, CEO of ProMedica
      HCR ManorCare deal laid foundation for ProMedica’s growth
      Steve Strongwater
      How Atrius Health stayed independent by not shying away from risk
      Why moving the VA to a new EHR was a pivotal decision
      Why AdventHealth's rebrand was more than a name change
    • Terry Shaw
      A diverse and inclusive culture should empower others
      Paving the path to diversity and inclusion
      The next step in healthcare evolution
      Breaking Bias: A road map to boost women and minorities into healthcare leadership
    • Dr. Richard Snyder
      Outdated privacy laws hinder coordinated care, especially in the fight against addiction
      David Dill and Keith Myers
      Healthcare partnerships are a proven path to better care, healthier communities
      Health systems need to devote more resources to caring for the caregivers
      Chip Kahn and Alan Morgan
      Rural healthcare needs innovation, policy changes to survive
    • Letters: Let’s keep humanity in discussions about patient safety
      Hospital with money
      Letters: Let providers set their prices,
 and then publish them all
      Letters: Ambulatory surgery centers aren't getting a break on regulation
      Letters: Rising Medicaid spending isn't a windfall for providers
    • Sponsored Content Provided By Optum
      How blockchain could ease frustration with the payment process
      Sponsored Content Provided By Optum
      Three steps to better data-sharing for payer and provider CIOs
      Sponsored Content Provided By Optum
      Reduce total cost of care: 6 reasons why providers and payers should tackle the challenge together
      Sponsored Content Provided By Optum
      Why CIOs went from back-office operators to mission-critical innovators
  • Awards
    • Nominate
    • Award Programs
    • Previous Award Programs
    • Other Award Programs
    • Nominations Open - Top 25 Minority Leaders
      Nominations Open - Health Care Hall of Fame
    • 100 Most Influential People
    • 50 Most Influential Clinical Executives
    • Best Places to Work in Healthcare
    • Health Care Hall of Fame
    • Healthcare Marketing Impact Awards
    • Top 25 Emerging Leaders
    • Top 25 Innovators
    • Top 25 Minority Leaders
    • Top 25 Women Leaders
    • Excellence in Nursing Awards
    • Design Awards
    • Top 25 COOs in Healthcare
    • 100 Top Hospitals
    • ACHE Awards
  • Events
    • Conferences
    • Galas
    • Webinars
    • Leadership Symposium
    • Healthcare Transformation Summit
    • Critical Connections: Social Determinants of Health Symposium
    • Women Leaders in Healthcare Conference
    • Workplace of the Future Conference
    • Strategic Marketing Conference
    • Health Care Hall of Fame Gala
    • Top 25 Women Leaders Gala
    • Best Places to Work Awards Gala
    • Top 25 Minority Leaders Gala (2020)
  • MORE +
    • Advertise
    • Media Kit
    • Newsletters
    • Jobs
    • People on the Move
    • Reprints & Licensing
MENU
Breadcrumb
  1. Home
  2. Government
November 29, 2016 12:00 AM

21st Century Cures Act reboot keeps controversial changes for FDA

Adam Rubenfire
Shannon Muchmore
  • Tweet
  • Share
  • Share
  • Email
  • More
    Print

    With Congress poised to vote this week on a fast-tracked reboot of the 21st Century Cures Act, manufacturers of prescription drugs and medical devices may be about to win long-sought revisions to how the Food and Drug Administration approves and regulates their products.

    The bill proposes major changes to the FDA's oversight of drugs, devices and biologics, while also opening new avenues for quicker approval of unique products. It also authorizes $500 million in new FDA funding over the next 10 years to implement the changes, although that money would have to be appropriated in future legislation.

    The House was expected to vote on the bill as soon as Wednesday.

    Pharmaceutical Research and Manufacturers of America, the nation's major drug lobby, said in a statement that the legislation would “enhance the FDA's ability to adapt to cutting-edge technologies utilized by America's biopharmaceutical companies to bring new medicines to patients and their healthcare professionals.”

    When legislation moved through the House under the same name last year, the FDA provisions raised concerns from consumer advocates and some policy experts that patients could be harmed while speeding medical innovation to market.

    Dr. Michael Carome, director of Public Citizen's Health Research Group, said the latest version of the Cures legislation poses the same risks.

    “What this will do is it will hasten to market drugs and devices where there is not adequate evidence that they are safe and effective for their approved uses, and that's not good for patients,” Carome said.

    Many details of the legislation were fluid Tuesday as lawmakers traded concessions to get it passed this week.

    But the published provisions have won enthusiastic support from research institutions and patient advocacy groups eager to see more federal funding and regulations supporting their work and causes.

    Amanda Jezek, vice president for public policy and government relations at the Infectious Diseases Society of America, said she is glad to see the newest draft include improved methods for getting more antibiotics to the market.

    The Cures Act includes an approval pathway allowing smaller clinical trials for antibacterial drugs that can treat infections that are resistant to existing treatments.

    Antibiotic resistance levels are continuing to climb and make practicing medicine especially difficult for doctors with patients who have limited ability to fight infections, Jezek said. “Unfortunately, antibiotic development is nowhere near keeping pace with antibiotic resistance.”

    That provision has received bipartisan support in previous versions of the legislation and is also supported by numerous industry organizations and patient advocacy groups, she said. Another provision lets the FDA approve antimicrobial drugs based on a limited population if the drug treats a life-threatening infection.

    The bill would also create a “breakthrough device” pathway that allows products that achieve the designation to proceed through an expedited development and review process. It also raises the population cap to 8,000 patients from 4,000 on the humanitarian device exemption, which allows devicemakers to get approval for a device intended for a very small population without having to demonstrate its effectiveness in treating the targeted disease.

    Scott Whitaker, CEO of the Advanced Medical Technology Association, called the breakthrough device pathway the most significant FDA improvement offered in the bill. Like PhRMA, the device lobby called for Congress to quickly pass the legislation.

    The “innovation ecosystem” that drives device development is severely stressed, Whitaker said. “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.”

    Some provisions require the FDA to give more weight to patient input and experience data, and they require the agency to lay out guidance for how such data should be collected.

    Another part of the bill requires the FDA to consider real-world evidence or data in making approval decisions or evaluating studies required after approval, despite concerns that such data is not necessarily reliable.

    Two provisions that Carome of Public Citizen identified as especially alarming would make it easier for pharmaceutical companies to get drugs already on the market approved for additional uses. One would allow the use of real-world evidence instead of randomized clinical trials. The other would allow the use of data summaries instead of individual-level data.

    “They substantially undermine the process for approval of drugs,” Carome said.

    Sen. Bernie Sanders (I-Vt.) who railed against drug prices during his upstart campaign for the Democratic presidential nomination, noted in a statement Tuesday that the Cures bill does nothing to address that issue—which was also frequently raised during the campaign by President-elect Donald Trump.

    “The greed of the pharmaceutical industry has no limit, and this bill includes numerous corporate giveaways that will make drug companies even richer,” Sanders said.

    Letter
    to the
    Editor

    Send us a letter

    Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.

    Recommended for You
    Sponsored Content
    Get Free Newsletters

    Sign up for free enewsletters and alerts to receive breaking news and in-depth coverage of healthcare events and trends, as they happen, right to your inbox.

    Subscribe Today

    The weekly magazine, websites, research and databases provide a powerful and all-encompassing industry presence. We help you make informed business decisions and lead your organizations to success.

    Subscribe
    Connect with Us
    • LinkedIn
    • Twitter
    • Facebook
    • RSS
    • Instagram

    Stay Connected

    Join the conversation with Modern Healthcare through our social media pages

    MDHC_Logotype_white
    Contact Us

    (877) 812-1581

    Email us

     

    Resources
    • Contact Us
    • Advertise with Us
    • Ad Choices Ad Choices
    • Sitemap
    Editorial Dept
    • Submission Guidelines
    • Code of Ethics
    • Awards
    • About Us
    Legal
    • Terms and Conditions
    • Privacy Policy
    Modern Healthcare
    Copyright © 1996-2019. Crain Communications, Inc. All Rights Reserved.
    • News
      • This Week's News
      • Providers
      • Insurance
      • Government
      • Finance
      • Technology
      • Safety & Quality
      • People
      • Regional News
        • Midwest
        • Northeast
        • South
        • West
      • Digital Edition
    • Special Features
      • Best Practices
      • InDepth Special Reports
      • Innovations
    • Transformation
      • Patients
      • Operations
      • Care Delivery
      • Payment
    • Data/Lists
      • Rankings/Lists
      • Data Points
      • Modern Healthcare Metrics
    • Op-Ed
      • Bold Moves
      • Breaking Bias
      • Commentaries
      • Letters
      • Vital Signs Blog
      • From the Editor
    • Awards
      • Nominate
      • Award Programs
        • 100 Most Influential People
        • 50 Most Influential Clinical Executives
        • Best Places to Work in Healthcare
        • Health Care Hall of Fame
        • Healthcare Marketing Impact Awards
        • Top 25 Emerging Leaders
        • Top 25 Innovators
        • Top 25 Minority Leaders
        • Top 25 Women Leaders
      • Previous Award Programs
        • Excellence in Nursing Awards
        • Design Awards
        • Top 25 COOs in Healthcare
      • Other Award Programs
        • 100 Top Hospitals
        • ACHE Awards
    • Events
      • Conferences
        • Leadership Symposium
        • Healthcare Transformation Summit
        • Critical Connections: Social Determinants of Health Symposium
        • Women Leaders in Healthcare Conference
        • Workplace of the Future Conference
        • Strategic Marketing Conference
      • Galas
        • Health Care Hall of Fame Gala
        • Top 25 Women Leaders Gala
        • Best Places to Work Awards Gala
        • Top 25 Minority Leaders Gala (2020)
      • Webinars
    • MORE +
      • Advertise
      • Media Kit
      • Newsletters
      • Jobs
      • People on the Move
      • Reprints & Licensing