Insights On Right To Try Act And 'Expanded Access' Concerns

By Mark Barnes, Greg Levine, David Peloquin and Michael DiMaio (December 18, 2018, 11:12 AM EST) -- In an earlier article authored by Ropes & Gray LLP attorneys, we summarized the implications of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, or the RTT.[1] President Donald Trump signed the RTT into law in May 2018 to provide patients who are not eligible for enrollment in a clinical trial with a pathway to obtain investigational drugs or biologics for therapeutic use. There is an existing expanded access, or EA, pathway, however, referred to colloquially as "compassionate use," that also provides access to investigational products for therapeutic use. Generally, under both pathways, the eligibility criteria are similar: the patient must (1) have a life-threatening condition for which no other treatment is available; (2) have exhausted available treatment options; and (3) be unable to participate in a clinical trial. Both pathways also require manufacturer approval and informed consent of the patient. However, access though the RTT pathway removes administration of the investigational product from institutional review board, or IRB, and U.S. Food and Drug Administration oversight, among other changes....

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