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Holly Fernandez Lynch (former Executive Director and Academic Fellow Alumna), Patricia J. Zettler, Ameet Sarpatwari
JAMA
August 13, 2018

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Former Executive Director and Academic Fellow Alumna Holly Fernandez Lynch has co-authored an opinion piece on the federal Right to Try Act of 2017. From the article:

On May 30, 2018, President Trump signed into law the federal Right to Try Act of 2017,1 providing patients with life-threatening conditions a pathway to access investigational drugs without authorization from the Food and Drug Administration (FDA). Ethicists, physicians, and patient groups have raised concerns about this type of legislation at the state and national levels given its implications for patients and the FDA’s public health mission.2,3 Now that “Right to Try” has become federal law, however, there is an opportunity to clarify statutory ambiguities that may help minimize the law’s potential to cause harm and advance its goal of encouraging companies to provide preapproval access to investigational drugs.

Read the full piece in JAMA!

Read the Full Article

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christopher robertson   clinical research   health law policy   holly fernandez lynch   human subjects research   medical safety   pharmaceuticals   public health