Division of Medical Ethics Working Group on Compassionate Use & Preapproval Access | NYU Langone Health

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Division of Medical Ethics Research Division of Medical Ethics Working Group on Compassionate Use & Preapproval Access

Division of Medical Ethics Working Group on Compassionate Use & Preapproval Access

The mission of the Working Group on Compassionate Use and Preapproval Access (CUPA) is to advance research, policy, and education regarding the ethical issues surrounding access to investigational medical products. CUPA strives to ensure the fair and transparent treatment of all patients.

Who We Are

Founded in 2014, CUPA is part of NYU Langone’s Division of Medical Ethics. CUPA studies the many ethical issues surrounding patient access to investigational medical products, through both clinical trials and nontrial pathways. For more information on the specific ethical issues we investigate, please see our frequently asked questions.

CUPA members represent relevant stakeholder groups, including patient advocacy, medicine, regulatory entities, industry, law, and academia. We engage and learn from these stakeholders and conduct research on identified issues. We use research findings to formulate policy proposals. As part of our education mission, we sponsor webinars and seminars for all interested parties to advance understanding of the ethics of preapproval access.

CUPA is co-chaired by Arthur L. Caplan, PhD, founding director of the Division of Medical Ethics, and Alison Bateman-House, PhD, MPH, assistant professor in the division.

What We Do

The following are CUPA’s main responsibilities, activities, and accomplishments:

  • We issue policy factsheets and recommendations on issues related to preapproval access.
  • We work with patient groups and medical providers to demystify preapproval access and to create community-specific resources.
  • We educate members of the pharmaceutical and biotechnology industries about preapproval access, best practices, and what ethical concerns need to be addressed.
  • Publishing in peer-reviewed journals and mainstream publications, CUPA members have received extensive coverage in major media outlets including The New York Times, the Los Angeles Times, CBS, STAT, Harper’s Magazine, Forbes, and NPR, among others.
  • Serving as the independent go-to resource for issues related to preapproval access, both in the United States and internationally, CUPA members have provided congressional testimony and speak frequently at conferences and seminars around the world.

Learn more about seeking preapproval access to an investigational medical product from our resources.

Disclosure

The Working Group on Compassionate Use and Preapproval Access is an independent, separate entity from the Division of Medical Ethics Compassionate Use Advisory Committees, though the idea for the committees came from discussions among our members. The Division of Medical Ethics pays overhead costs and other expenses for the Working Group. We receive income from a variety of sources, including private gifts and contracted projects. Individual members are not compensated. We do not represent an official view of NYU Langone Health or any employer or other institutional affiliation of any working group member.

The Working Group advises state and federal legislators and FDA leadership on policy, but we do not advocate for particular legislation or promote an agenda. Our members have testified about patient access to investigational drugs before the Subcommittee on Health of the U.S. House of Representatives’ Energy and Commerce Committee.

Contact Us

For general inquiries, please contact Lisa Kearns, MS, MA, senior research associate, at lisa.kearns@nyulangone.org. For media inquiries or to sign up to receive occasional emails about compassionate use and preapproval access, please contact Beba Blagojevic, project coordinator, at bratislava.blagojevic@nyulangone.org or 646-501-2832.