FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Right-to-Try Laws Could Dampen Industry Participation in Expanded Access Programs

Aug. 16, 2017
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Variations in right-to-try laws passed in multiple states and at the federal level could mean compliance headaches for companies taking part in expanded access.

Texas, for example, bars manufacturers from charging for treatment, while other states allow it. Four more states’ laws do not apply to patients being treated in hospitals. Arizona does not allow primary care providers to request investigational treatments, while Oregon’s policy does not apply to patients under 18. And still more states have varying definitions of “terminally ill.”

“Regulatory folks at companies are going to have to know who’s getting the drug, and it’s going to vary what kind of protections or rules are demanded,” said Alison Bateman-House, a bioethicist and professor who co-chairs a NYU Langone Health working group on expanded access.

“And, of course, patients travel from state-to-state to seek specialty care,” she added. Bateman-House’s research, with her NYU colleague Lisa Kearns, was published in the journal Therapeutic Innovation & Regulatory Science.

Most of the laws began as model legislation supplied by the libertarian Goldwater Institute, which tracks the progress of the bills nationwide. Currently 37 states have passed right-to-try bills, with more pending.

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