There's Already a Better Alternative to Proposed "Right to Try" Legislation: Keep the FDA Involved in Expanded Access

Article ID: 689350

Released: 12-Feb-2018 10:05 AM EST

Source Newsroom: Clinical Research Pathways

Expert Pitch
  • Credit: Marjorie Speers

Newswise — Marjorie Speers, Ph.D., is available to speak with journalists covering the proposed "right to try" legislation involving making experimental or investigational drugs available to desperately ill or terminal patients. Her point of view is that the existing expanded access process, which includes FDA review, works well -- especially in the area of looking out for and protecting patients in the process. The FDA already approves over 99 percent of expanded access requests.

The issue of expanded access is one of the key areas of focus for the non-profit WCG Foundation, which she now leads.

Her biography :
Marjorie A. Speers, Ph.D., is a global leader in human research protections. Most recently, she was founding president and CEO of the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), retiring in 2013. Dr. Speers views the opportunity to lead this one-of-a-kind foundation—and continue to contribute to research protections and public well-being worldwide—as the natural progression in a career of public service. Before establishing AAHRPP in 2001, she served as acting executive director of the National Bioethics Advisory Commission. At the Centers for Disease Control and Prevention, she oversaw research protections for all domestic and international research. Dr. Speers is a graduate of Dickinson College, where she serves on the Board of Trustees and established a scholarship that has benefited numerous international students. She also holds doctoral degrees in psychology and epidemiology from Yale University.


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