Saved Josh: The gears of a successful patient advocacy campaign
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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
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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.