Webinar Follow-Up: Pre-Approval Access to Drugs in Development: Navigating the Changing Regulatory, Ethical, and Legal Landscape

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30 Aug

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Expanded access, which is treatment access to experimental drugs (also referred to as "compassionate use" or "pre-approval access"), has generated increasing interest and debate over the last several years. On March 7, PRIM&R hosted a webinar, Pre-Approval Access to Drugs in Development: Navigating the Changing Regulatory, Ethical, and Legal Landscape, to educate HRPP professionals on FDA guidance, recent legislation, and ethical questions related to expanded access. The webinar featured Richard Klein, the former director of the FDA's Patient Liaison Program in the Office of Health and Constituent Affairs, and Beth E. Roxland, JD, MBioethics, an Attorney, Bioethicist, and Senior Advisor on Law, Health Policy and Ethics at Roxland Consultants, Ltd. After the webinar, Mr. Klein responded to some of the attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand. Read more

21
Aug2018

Taking a Closer Look at the New Federal “Right to Try” Law

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21 Aug

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On May 30, 2018, the four-year Right to Try (RTT) movement culminated in a new federal law, with the stated goal of providing terminally ill patients with a new route of access to early phase investigational drugs that are currently in clinical development and not approved or generally available to all patients in need. RTT laws seek to remove federal FDA oversight and regulations from the pre-approval process, in which patients seek to access experimental drugs in development outside of the clinical trials in which the drugs are being tested, despite the fact that terminally ill patients already had the right to request such access under FDA regulations for decades through the Expanded Access Program. Read more