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.
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The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.