Creative Tension: FDA and Medicine

Since joining the Food and Drug Administration, I have been exposed to a remarkable array of correspondence from well credentialed practicing physicians. Some of them are my former students from Stanford, others are former classmates at Harvard, and still others seem not to require any help from prior acquaintance. Many believe that the FDA is failing in its obligation to the medical profession in several ways: by appearing to ignore the wisdom of clinical experience in its decisions about drugs; by denying American physicians a number of new medicines readily available overseas and unduly delaying those developed domestically; and by . . .