Obama Signs Rare Clinical Trial Compensation Legislation into Law

President Barack Obama Oct. 7 signed a bill into law that will compensate patients for participating in clinical studies of rare diseases.

The U.S. House of Representatives approved the bill on Sept. 28.

An update to a 2009 law, the Ensuring Access to Clinical Trials Act of 2015 will allow patients with rare diseases to collect up to $2,000 per year without having the compensation count as income that could jeopardize eligibility for Supplemental Security Income and Medicaid.

The bill S. 139 — which passed the Senate in July — also would repeals a five-year sunset clause in the 2009 law.

The National Organization for Rare Disorders praised the bill’s passage, saying it will remove income-related barriers to trial participation. According to the group, only a few hundred of the roughly 7,000 rare diseases in the U.S. have FDA-approved treatments.

The 21st Century Cures Act, which passed the House in May, also contains separate incentives for development of drugs for rare diseases. Comparable legislation is being crafted by the Senate HELP Committee.

Read S. 139 here: www.fdanews.com/09-30-15-compensation.pdf. — Victoria Pelham

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