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This month’s question places you in the FDA commissioner’s seat: You are the Commissioner of the FDA. A friend has informed you of the following situation: Over 1,000 people with severe, refractive emphysema have banded together to test a drug that is approved for asthma but not emphysema. Participants “drew straws” to determine which of them would ask their physicians for a prescription. While the FDA has no authority over the practice of medicine, it does have authority over clinical studies that create generalizable knowledge. Read more


by Susie A. Han and Valerie Gutmann Koch

Susie A. Han, MA, MA, is the deputy director and principal policy analyst of the New York State Task Force on Life and the Law. Valerie Gutmann Koch, JD, is a visiting assistant professor at Chicago-Kent College of Law, lecturer at the MacLean Center for Clinical Medical Ethics, and special advisor to the New York State Task Force on Life and the Law; she is the former senior attorney and consultant to the Task Force.  

First-person informed consent—a [...] Read more