Deadly Overcaution: FDA's Drug Approval Process

Deadly Overcaution: FDA's Drug Approval Process

September 01, 1990
Originally published in Journal of Regulation and Social Costs

Full article available in pdf format

When the federal Food and Drug Administration announces its approval of an important new drug, the event is invariably portrayed as an administrative achievement.  This has always puzzled me.  It seems that a question hangs over these announcements that almost always goes unasked, though I understand why FDA might not care to answer it.  The question is this:  If a drug that has just been approved by the FDA will start saving lives tomorrow then how many people died yesterday waiting for the agency to act?