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News and Press: Policy News

Federal Right to Try Act Introduced

Thursday, July 16, 2015   (0 Comments)
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A federal Right to Try Act of 2015 (H.R. 3012) was introduced in the U.S. House of Representatives last week and referred both to the Energy & Commerce Committee and Judiciary Committee. 

The bill seeks to expand the access of terminally ill patients to experimental drugs in a novel way, by prohibiting the federal government, including FDA and DEA, from taking action to stop such access. However, by preventing FDA from taking any action to stop access, it potentially undermines the agency’s entire expanded access regulatory process.

This federal bill gives partiality to state law (22 states have now passed Right to Try legislation including Michigan), most of which require that patients need approval only from their physician (a prescription) and the drug company to gain access to investigational drugs and treatments.

There is ambiguity – It’s unclear if the FDA would be prevented from taking any enforcement action against a company who ignored the expanded access regulations. In turn, would companies forego FDA approval given such ambiguity?

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