FDA LAW Blog: December 10, 2014 Expansion of Expanded Access? Federal Right to Try Legislation is Introduced By James C. Shehan –

Over the past year, the plight of seriously ill patients seeking access to unapproved drugs has led five states to pass laws that permit manufacturers to provide patients in those states with investigational drugs on an emergency basis without going through the FDA’s expanded access process (see here and here). Now the public debate over this issue has led to the introduction of a bill, H.R.5805, in the House of Representatives. Taking a different approach than the state laws, H.R. 8505 would not bypass FDA but instead supplement FDA’s expanded access process with provisions requiring companies to provide FDA and patients with more information about how they deal with requests for expanded access.

H.R. 8505, sponsored by Representative Michael McCaul (R-TX), would create the Andrea Sloan Compassionate Use Reform and Enhancement (CURE) Act. The bill is named after Andrea Sloan, an Austin resident who died on New Year's Day after unsuccessfully seeking denied access to a potentially lifesaving drug to treat her ovarian cancer.

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