Medical ethicists call for clarity on 'right to try' - Bio-Defense Network
Aug 2018

Medical ethicists call for clarity on ‘right to try’

Medical ethicists are making the case that the FDA needs to clear a few things up about the “right to try” law passed in May. In a paper just published in JAMA, experts say the FDA needs to address four areas: drug eligibility, patient eligibility, reporting requirements, and the law’s intersection with the FDA’s existing expanded access program. Under the law, patients have to be “unable to participate” in a clinical trial to be eligible for experimental access. The authors say the FDA needs to explain exactly what that means so the law doesn’t interfere with study enrollment. Clarity could also “help prevent the rise of a market in unproven therapies and preserve the ability to collect critical information about investigational drugs,” they write.

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