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September 4, 2018

Promoting Patient Interests in Implementing the Federal Right to Try Act

Author Affiliations
  • 1Department of Medical Ethics and Health Policy, Perelman School of Medicine, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia
  • 2Center for Law, Health, and Society, Georgia State University College of Law, Atlanta
  • 3Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
JAMA. 2018;320(9):869-870. doi:10.1001/jama.2018.9880

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.

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