Weighing the Merits of Right-to-Try Laws and FDA’s Expanded Access Program

Weighing the Merits of Right-to-Try Laws and FDA’s Expanded Access Program

Published February 27, 2018 by The American Journal of Managed Care

Just a month before attendees gathered in Philadelphia, Pennsylvania, for the annual meeting of Patient-Centered Oncology Care®, legislators in the state’s capital of Harrisburg made it the 38th to pass a right-to-try law. That was 6 states in 2017 alone.1 Championed by conservative groups like the Goldwater Institute as well as Vice President Mike Pence,2 the laws sound good on their face: they can connect terminally ill patients with experimental treatments; even opponents say the idea of giving dying patients “one last chance” is hard to oppose.

But as panelists discussed during the session presented by The American Journal of Managed Care®, these state laws are not necessarily good for patients or long-term drug development, and there is a better alternative: the FDA’s newly streamlined Expanded Access program, which allows patients to gain access to investigational therapies in a more regulated way, with greater accountability. Thus, there is great concern about a proposed federal right-to-try legislation, including a version that has passed the United States Senate.

The panel featured W. Kevin Kelly, DO, director of the Division of Solid Tumor Oncology at the Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia; Marjorie A. Speers, PhD, executive director for the WCG Foundation; and Diana Zuckerman, PhD, president of the National Center for Health Research, board member of the Reagan-Udall Foundation.

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2018-07-02T14:47:26+00:00February 27, 2018|News|