• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Kids v Cancer

Changing the landscape of pediatric research

DONATE
  • Who We Are
    • About Us
    • About Jacob
    • Mission and Impact
    • Press Kit
    • Contact
  • Policy Development
    • RACE for Children Act / PREA
    • Creating Hope Act / Pediatric Priority Review Vouchers
    • Kids’ Eligibility for Trials
  • For Doctors & Families
    • COMPASSIONATE USE NAVIGATOR
    • Brain Tissue Donation
  • News & publications
    • News
    • Pediatric Cancer Legislative Yearbook 2019
    • Pediatric Cancer Research Consortia 2019
    • Kids v Cancer End of Year Letter 2017
    • Blog
  • Youth Programs
    • All programs
    • Climb the Hill Youth Advocacy Day Sign Up
    • Video and photo gallery
    • Kids v Cancer Youth Board
  • Our stories
  • Get involved
    • Donate
    • Our Parent Council
    • Happy Day Gift
    • Become a Corporate Partner

Reports, Legislation, Articles

Saved Josh: The gears of a successful patient advocacy campaign

Download PDF of case study
Kids v Cancer created the Compassionate Use Navigator inspired by our efforts to help Josh Hardy, a 7-year-old Virginia boy who battled cancer all his life. In March 2014, Josh urgently needed compassionate use access to a drug to fight a life-threatening infection. When the manufacturer denied repeated pleas to provide the drug, the Hardy family took their case to television, newspapers, social media, and patient advocates. With help from patient advocacy organizations, Josh received the drug and survived. Please read our full account of the campaign to save Josh.

 

Andrea Sloan compassionate use reform and enhancement act (CURE) H.R. 580

Download PDF of H.R. 580
The Andrew Sloan Compassionate Use Reform and Enhancement Act (CURE), H.R. 5805, was introduced by Congressman Michael McCaul in the House of Representatives on December 8, 2014, and is named after a Texas woman who died from ovarian cancer while seeking compassionate use access to experimental drugs.

The bill requires companies to publicly disclose basic information about their compassionate use policies for drugs that are being developed to meet serious, unmet needs — drugs that FDA has designated as a breakthrough therapies, fast track products, infectious disease products, or orphan drugs. Under the CURES bill, manufacturers would have to publish the minimum criteria for considering or approving compassionate use requests, and the time needed to make a decision. Companies would have to provide an explanation to a patient within five days if they deny a compassionate use request.

The CURES bill also instructs the Government Accountability Office (GAO) to write a report with recommendations for improving compassionate access, and for FDA to write a guidance document incorporating the GAO’s recommendations.

Please contact your member of Congress to express your support for enactment of the Andrea Sloan Act.

  • Compassionate Use Navigator
  • Request Our Help
  • Information for Families
    • Application Steps
  • Information for Physicians
    • Expanded Access Explained
    • Apply to a Drug Manufacturer
    • Apply for FDA Authorization
    • Apply to IRB
    • Safety Reports Requirements
    • Handout — All Application Steps
  • Forms and Templates
  • Precision Medicine Clinical Trials Involving Pediatric Patients
  • Reports, Legislation, Articles
  • Advisory Council
  • Contribute to Our Outcomes Database
  • Compassionate Use News
link to Information for Families
Information for Families

 

Information for Physicians

  • Facebook
  • Twitter

DONATE CONFLICT OF INTEREST SUBSCRIBE

Kids v Cancer · 3500 Macomb Street NW · Washington D.C. 20016 · 646-361-3590 · contact

© 2019 Kids v Cancer · All Rights Reserved a 501(c)(3) nonprofit organization · EIN 27-1427784 · Privacy Policy · Terms of Use · Sitemap