In DepthPatient Advocacy

‘Right to Try’ laws bypass FDA for last-ditch treatments

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Science  20 Jun 2014:
Vol. 344, Issue 6190, pp. 1329
DOI: 10.1126/science.344.6190.1329

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Several state legislatures, prodded by desperately ill patients and a libertarian think tank, are defying federal regulators to make experimental drugs available to terminally ill patients outside of clinical trials. The new laws, called Right to Try, went on the books in two states last month and are being considered in several others. One company has already announced its plans to use the laws to offer its stem cell treatment well ahead of approval from the Food and Drug Administration. But skeptics say few companies will be willing to bear the costs and risks of offering a drug outside of its clinical trials, especially if it means defying federal law.