The Importance of Legislative Reform of the Fda

Abstract

The US Food and Drug Administration (FDA) has raised the regulatory burden on drug companies by continually introducing new requirements and policies, regardless of their potential to hinder the delivery of new and innovative therapies to patients who need them. the drug development system in the United States has become the slowest and most expensive in the world. In a climate of deregulation, FDA has sought to cultivate the image of an agency reforming itself from within—lessening the burden on regulated industry and lowering review times—but such “improvements” are largely illusory. FDA has shown itselfincapable of reforming itself, and only carefully crafted legislation will significantly improve the oversight of drug development.