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Medical Centers Need Policies for Right-to-Try Oversight

Jan. 30, 2019, 10:30 AM

A federal experimental medicines access law aims to skirt FDA regulations, but academic medical centers still should consider imposing their own gatekeeping mechanisms, a research attorney noted.

The law, commonly known as right-to-try, gives patients with life-threatening conditions the chance to try unapproved drugs, but doesn’t mention how institutions’ oversight functions factor into the process, Verrill Dana, LLP attorney Kate Gallin Heffernan told a group of health lawyers.

“That’s up to you if you want to think about right-to-try as an option,” she said, but advised institutions to create policies and procedures to avoid potential risks rather than just alerting ...