Healthy Skepticism Library item: 8222

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Wechsler J.
Final reform bill modernizes FDA, permits dissemination of off-label and economic data
Formulary 1997 Dec; 32:1253-1254

Abstract:

The final U.S. Food and Drug Administration (FDA) reform bill that codifies many new FDA regulations, revises agency policies, updates a number of outdated FDA practices, reauthorizes the Prescription Drug User Fee Act of 1992 (PDUFA) for another 5 yr, and permits drug companies to disseminate information that primarily discusses off-label drug uses and distribute data regarding the economic consequences of a drug product to sophisticated purchasers such as managed care plans and formulary committees is discussed.