Abstract
I dislike bully-boy tactics, and last month I witnessed a prize exhibition. It was all quite unanticipated. I heard that the FDA was being called on to respond to allegations of "drug lag." (Does the United States lag behind England in the availability of effective, safe, new drugs?) I was interested in the FDA response, because it is a key issue in whichThe Journalhas taken keen interest. Recent communications by Freis, Wardell, and Lasagna have reflected our concern that the FDA (in its zeal to comply with the 1962 Kefauver mandates) perhaps has been overly cautious in releasing new drugs that have been proven safe and effective in England, to the American physician. In response to this, Commissioner Schmidt has said, "We believe we have done much in recent years to recognize and correct problems in our own house which have contributed unnecessarily to delaying decision-making on new
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