EVOLUTION AND REVOLUTION IN DRUG LABELING - REGULATION OF ANTIARRHYTHMIC DRUGS BY THE FOOD-AND-DRUG-ADMINISTRATION 1962-1996

Between 1962, when the Kefauver-Harris Drug Amendments were passed, an d 1996, 20 pharmaceutical compounds were approved and labeled by the F DA as effective antiarrhythmic drugs for some specified cardiac arrhyt hmia. Drug research and development in the 1970s and 1980s were focuse d on treatment of premature ventricular beats as a marker for sudden c ardiac death and ventricular tachycardia. The Cardiac Arrhythmia Suppr ession Trial in 1989 irrevocably altered this approach. Recent drug de velopment programs have targeted atrial fibrillation (AF) as epidemiol ogic data have predicted an increase in the incidence of AF as the Uni ted States population ages, and as treating premature ventricular beat s has fallen from favor. The FDA, the scientific community, and the ph armaceutical industry have all participated in and been affected by th is evolution in drug development.