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Bolder Cures Act Could Ease Limits On Drug Cost Claims, Law360

May 26, 2015

A brief section in the fast-evolving 21st Century Cures Act would modestly loosen U.S. Food and Drug Administration restrictions on drugmaker claims of cost-effectiveness but will only provide significant cover from enforcement actions if lawmakers get bolder with the legislative language, experts say.

FDA partner Stephen Paul Mahinka is quoted regarding proposed tweaks to Section 114 of the Food and Drug Administration Modernization Act of 1997.

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