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Hastings Center News

Helping Seriously Ill Patients Access “Last Resort” Medicines

The Compassionate Use Advisory Committee, headed by Hastings Center Fellow Arthur Caplan, of NYU Langone, received the Reagan-Udall Foundation for the Food and Drug Administration’s Innovation Award on December 11. The committee was recognized for transforming how expanded access requests, also known as compassionate use requests, are granted by drug developers. “Our goal is to help drug companies better evaluate patient requests for experimental therapies and make these therapies available,” Caplan said. “This is the patient’s last resort in many cases.” He said the program represents a very practical application of bioethical  theories of fairness and justice to directly helping patients and their families—a very real example of “translational bioethics.”

Mildred Solomon, president of The Hastings Center, said: “This is a great example of the importance of bioethics in people’s lives.  The committee worked through many of the ethical pitfalls that can arise, if we start making unproven therapies available outside trials and before all the evidence is in. It came up with great approaches that have brought experimental drugs to thousands of desperate people, while maintaining the integrity of our research oversight system.”