• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends

    Power Trip: A Discussion of Custom Medical Electronics

    The MDR Transition: An Opportunity for Design Change?

    Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    Beckman Coulter Helping Labs Comply With Annex 1 Regulation

    FDA Clears MeMed BV Direct From Whole Blood

    Biostrap Debuts Tool to Measure Stress Resilience, Heart Rate Variability

    EndoTheia Announces Positive Study Results for Endoscopic Surgery Device

    Abbott Completes Acquisition of Bigfoot Biomedical
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends

    Power Trip: A Discussion of Custom Medical Electronics

    The MDR Transition: An Opportunity for Design Change?

    Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Medtech’s Most Powerful M&A Drivers

    The Link Between Medtech and Connected Medical Devices

    Is the FTC Partly Responsible for Muted M&A Activity?

    Holistic Risk Management: Navigating the Future’s Uncertainties

    Defining End of Life for Medical Devices
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    LEMO USA Inc.

    Johari Digital Healthcare Ltd.

    Cirtec Medical

    Providence Enterprise USA Inc.

    Halkey-Roberts Corporation
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    A One-Stop-Shop, Turnkey Solution Is Paramount for Success

    How Additive and Subtractive Manufacturing Are Revolutionizing the Medical Device Industry

    Medical Device Commercialization: It’s What, Not When, to Transfer to Manufacturing

    How In Silico Simulations Can Slash Medical Device Development Risk

    The Top 7 AI Applications Transforming Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    LEMO USA Inc.

    Johari Digital Healthcare Ltd.

    Cirtec Medical

    Providence Enterprise USA Inc.

    Halkey-Roberts Corporation
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    New Efforts to Strengthen FDA’s Expanded Access Program

    EA provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices.

    Scott Gottlieb, M.D., Commissioner, U.S. Food and Drug Administration11.09.18
    Since the 1970s, the FDA has helped to facilitate access to promising investigational medical products for patients with serious or immediately life-threatening diseases who are unable to access products through clinical trials. As a cancer survivor, I understand, on a very personal level, that patients who are fighting serious or life-threatening diseases want the flexibility to try new therapeutic approaches, including investigational medical products. This is especially relevant when there’s no other FDA-approved treatment option available to a patient.
     
    FDA is deeply committed to facilitating this access, while also protecting patients and helping them to be able to make informed decisions with their physicians. We also take steps to help make sure that such access doesn’t interfere or jeopardize investigational trials that could support a medical product’s development or timely approval for the treatment indication.
     
    This is the mission of our Expanded Access (EA) program. EA provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices for serious diseases and immediately life-threatening conditions outside of clinical trials when no comparable or satisfactory approved alternative therapy options are available. We’re taking new steps to improve this framework.
     
    Over the last five years, FDA has authorized more than 9,000 applications across drugs, biologics, and devices through the agency’s expanded access program. Furthermore, we’ve authorized approximately 99 percent of all the requests we have received, across all application types.
     
    FDA staff is deeply committed to this program and ensuring that it works quickly and effectively for patients and their physicians. Emergency requests for individual patients are usually granted immediately by phone. Non-emergency requests are generally processed within a few days.
     
    Despite the success of the EA program, we recognize that there are opportunities for improvement. We’ve taken steps to expand and update the program over the last year. Many of these changes were made in response to feedback the agency received from stakeholders, as well as input from Congress, on how we can make the program more effective.
     
    One improvement FDA made was streamlining the required supporting documentation for expanded access requests submitted by a physician for access to a drug or biological for the treatment of an individual patient. These changes reduced the administrative burden for these physicians. Following these changes, we estimate that it takes about 45 minutes, on average, to complete a patient application form. That form typically requires just one attachment.
     
    We also simplified the process for Institutional Review Board (IRB) review. For single patient EA, we’ve modified the IRB review process to permit just one IRB member – the chair or another appropriate person – to concur with the treatment use rather than the entire Board.
     
    We also clarified in guidance how we use safety data generated from using an investigational drug or biologic through the EA pathway, recognizing and addressing companies’ concerns that EA-related adverse event data could be used in ways that complicate the review process.
     
    As part of FDA’s commitment to continuous operational improvement of the expanded access program, we announced last year that we commissioned an independent assessment of the program. The goals were to better understand the current EA program’s performance and identify ways to improve it. It considered stakeholder perspectives from across the healthcare ecosystem, including patients and their advocates/caregivers, healthcare providers and the health systems that support healthcare providers, payers, IRBs, manufacturers, and FDA staff.
     
    I’d like to highlight some of the key findings from this assessment, and how we are addressing the opportunities that we’ve identified as ways to strengthen the expanded access program.
    The assessment found overall support for FDA’s program, but as we hoped in pursuing this analysis, also identified new steps we can take to improve upon our efforts.
     
    For example, the assessment found that external stakeholders’ overall perceptions of FDA’s expanded access program—and FDA’s role in administering it—are very positive. Stakeholders across the health care system highlighted FDA’s commitment to expediting the review of EA applications, the FDA’s collaborative nature, and our focus on continuous improvement.
     
    Physicians with direct experience submitting an EA application to the FDA reported positive impressions of the program. Similarly, patients and their advocates described the program as a crucial route to access investigational therapies when other alternatives have been exhausted.
     
    Manufacturers, patient advocates, IRB representatives, and physicians all noted that FDA has taken key steps to reduce the administrative burden associated with submitting requests and recognized our commitment to facilitating medically appropriate access via the EA program.
     
    Stakeholders also reported some challenges across the physician and patient journey through the program, that, if properly addressed, could meaningfully enhance the program. This feedback is crucial in our continued efforts to improve the program.
     
    We’re already acting on these findings.
     
    For one thing, the assessment found that confusion with program navigation, multi-stakeholder coordination, and administrative burden were the most frequently-cited challenges. The assessment recommendations include improving FDA’s public website content and investing in resources to support patient/physician program navigation. These are areas where we’ve already taken steps to improve the program, or where we are working on improvements.
     
    For instance, based on the feedback from the assessment, today we announced that FDA’s EA webpages will be updated to improve usability through streamlining of content and a more user-friendly organization. This includes a reduction in duplication, as well as the addition of new pages with commonly requested information, such as forms and keywords.
     
    These updates will begin rolling out today and will continue in the future as we identify new opportunities to improve the usability of information on our EA webpages.
     
    As part of our recently announced proposed reorganization of the Office of the Commissioner, we intend to formally establish an agency-wide Patient Affairs Staff and Health Care Provider Affairs Program, under the oversight of the Office of Clinical Policy and Programs. This will enhance our engagement with these important external stakeholder groups. The Patient Affairs Staff is already in place and charged with serving as the “home base” and primary point of entry for patients and physicians starting the EA process and navigating them through the steps.
     
    Additionally, we’ve established an agency-wide Expanded Access Coordinating Committee, which facilitates cross-Center communication and promotes discussion to rapidly address cross-cutting issues related to expanded access to promote consistency and best practices.
     
    FDA is deeply committed to our Expanded Access program and facilitating access to medical products outside of clinical trials when no alternative therapy options are available to patients. And we are deeply committed to continuing to enhance this program going forward.
     
    It’s important to note that while expanded access represents FDA’s primary avenue for facilitating access for certain patients to unapproved, investigational treatments, the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017,” recently signed into law by the President, represents a separate and distinct pathway. The FDA has established a work group to consider what steps may be required to implement this legislation in a way that advances Congress’ intent to promote access and protect patients. Any work we undertake will build on our long-standing commitments to help patients facing life-threatening diseases or conditions access investigational medicines. As a first step, today we are launching a Right to Try webpage that will assist patients in understanding this alternative pathway.
     
    We’re dedicated to making sure that patients facing serious conditions have access to promising investigational medicines. We will continue to take new steps to advance these goals.
    Related Searches
    • safety
    • medical
    • clinical trials
    • healthcare
    Suggested For You
    MEDICAL & BIOTECH MANUFACTURING MEDICAL & BIOTECH MANUFACTURING
    Breakthrough Device Designation Granted for New Neuromodulation Platform Breakthrough Device Designation Granted for New Neuromodulation Platform
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    First CellFX Procedure Performed in Canada First CellFX Procedure Performed in Canada
    RedDress’ ActiGraft System Receives New FDA Clearance RedDress’ ActiGraft System Receives New FDA Clearance
    FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests
    FDA Clears Inova Diagnostics FDA Clears Inova Diagnostics' Digital Multi-Analyte System
    FDA Approves Abbott FDA Approves Abbott's Portico with FlexNav TAVR System
    Vicarious Surgical Business Combination with D8 Holdings Approved Vicarious Surgical Business Combination with D8 Holdings Approved
    Indago Announces $10 Million Financing Close and Name Change Indago Announces $10 Million Financing Close and Name Change
    Siemens Healthineers’ Somatom X.ceed Tomography Scanner Cleared by FDA Siemens Healthineers’ Somatom X.ceed Tomography Scanner Cleared by FDA
    Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe
    Vertigo Treatment Receives FDA Breakthrough Device Designation Vertigo Treatment Receives FDA Breakthrough Device Designation
    Quanta Raises $245 Million in Series D Funding Round Quanta Raises $245 Million in Series D Funding Round
    Thermo Fisher Scientific Launches Updated COVID-19 Test Thermo Fisher Scientific Launches Updated COVID-19 Test

    Related Literature / Brochures

    • MEDICAL & BIOTECH MANUFACTURING

      ISO 13485:2016 • FDA Registered

    • Breakthrough Device Designation Granted for New Neuromodulation Platform

      Breakthrough Device Designation Granted for New Neuromodulation Platform

      In a pilot study treating refractory epilepsy with Neuroelectrics’ Starstim platform, patients experienced a 44 percent median reduction in seizure frequency.
      Business Wire 09.22.21

    • Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Neela Paykel is serving as general counsel and Tom Teisseyre assumes the chief product officer position.
      Business Wire 09.22.21


    • First CellFX Procedure Performed in Canada

      First CellFX Procedure Performed in Canada

      Pulse Biosciences expands its controlled launch of the CellFX System into the country.
      Business Wire 09.22.21

    • RedDress’ ActiGraft System Receives New FDA Clearance

      RedDress’ ActiGraft System Receives New FDA Clearance

      ActiGraft Ver.02 System is intended for the safe and rapid POC preparation of an in-vitro blood clot.
      Globe Newswire 09.22.21

    Loading, Please Wait..

    Trending
    • Diabetes Innovation: MIT Engineers Unveil Implantable Device With Oxygen Factory
    • A New Approach To Post-Market Surveillance
    • Medtronic Obtains EU Nod For Simplera CGM
    • Danaher Names New Environmental And Applied Solutions Company Veralto
    • Hologic, Bayer Team Up For Contrast-Enhanced Mammography
    Breaking News
    • Beckman Coulter Helping Labs Comply With Annex 1 Regulation
    • FDA Clears MeMed BV Direct From Whole Blood
    • Biostrap Debuts Tool to Measure Stress Resilience, Heart Rate Variability
    • EndoTheia Announces Positive Study Results for Endoscopic Surgery Device
    • Abbott Completes Acquisition of Bigfoot Biomedical
    View Breaking News >
    CURRENT ISSUE

    September 2023

    • Superior Subtractive Solutions for Machining Medtech
    • Medical Device Industry Experts' Thought on Assembly & Automation
    • Power Trip: A Discussion of Custom Medical Electronics
    • The MDR Transition: An Opportunity for Design Change?
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    GOED Releases Sustainability Report for Omega-3s Industry
    ABC’s Journal HerbalGram Celebrates 40th Anniversary
    Curcumin May Be As Effective as PPI for Indigestion
    Coatings World

    Latest Breaking News From Coatings World

    Nouryon Manufacturing Network Transitions to 100% Electricity From Renewable Sources in Brazil
    Jay Doubman Named President and CEO of ICP Group
    “MyCarbonFootprint”: BASF Launches Dashboard for Sustainable Procurement
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Beckman Coulter Helping Labs Comply With Annex 1 Regulation
    FDA Clears MeMed BV Direct From Whole Blood
    Biostrap Debuts Tool to Measure Stress Resilience, Heart Rate Variability
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Eftilagimod Cleared for Clinical Trial Use in the UK
    Veranova Names William Sanders Global VP of Chemical Development Ops
    Chime, Panolos Partner to Advance Multi-specific Therapeutic Proteins
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Hailey Bieber's Rhode Expands Into Makeup
    Avon Enters Retail Partnership with Superdrug
    IT Award Winners Announced at MakeUp in NY
    Happi

    Latest Breaking News From Happi

    Divi Expands in Stores at Ulta Beauty Tripling Footprint
    Huda Beauty Adds Easy Bake and Snatch Pressed Brightening and Setting Powder
    Detergent for Baby Bottles Contains an Odor Absorber
    Ink World

    Latest Breaking News From Ink World

    INKBANK Lays Foundation for Science and Technology Park
    Successful Labelexpo Europe 2023 Concludes in Brussels
    Recyclable, Deinkable Stand-Up Pouch Wins Gold
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Flexo Wash to exhibit at FTA Fall Technical Conference
    Recyclable, deinkable stand-up pouch wins Gold in Germany
    Elkem highlights thermal protection and battery assembly products
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Lenzing Earns EU Ecolabel at Indonesian Plant
    Albis Completes Work On Extra Wide Carding, Blending Line
    Ahlstrom Launches Nonwoven Laundry Care Product
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Anika Releases RevoMotion Reverse Shoulder Arthroplasty System
    Exactech's Activit-E Polyethylene OK'ed for Vantage Total Ankle
    Tyber Nets Several Regulatory Nods for K-Wires, Steinmann Pins
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    HMI Specialist RAFI Acquires Xymox Technologies Inc.
    Infineon Heads EECONE European Research Project
    NXP Honored with Prestigious Automotive Awards

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login