ABSTRACT
A single agency, the Food and Drug Administration (FDA), regulates a trillion dollars
of products, ranging from 80% of the U.S. food supply to all human health care
products, electronic products that emit radiation, animal products, and cosmetics. In
2006, that agency approved 101 new drugs, 10 biologic license applications, and 39
devices under the premarket approval process and cleared 3217 devices1 and recalled
4266 products in all categories.2 That single agency is responsible for shellfish, stents,
over-the-counter (OTC) cough syrups, tetanus shots, artificial sweeteners, mam-
mography standards, prescription drugs, vitamins, and lipsticks, not to mention the
readability of calorie and trans-fat information on a bag of potato chips. The economic
impact of the FDA is difficult to calculate, the scientific challenges and increasing
medical needs overwhelming, and the expectations contradictory.
