FDA Reform: A Prescription for More and Better Drugs and Medical Devices
Properly tailored and limited regulation of biopharmaceutical products and medical devices helps to promote public safety, but the U.S. Food and Drug Administration’s regulations as currently designed hinder and slow the innovation process and retard the diffusion of medical improvements. Specifically, research indicates that current regulatory norms and the delays they engender unnecessarily bloat costs, discourage research and development, slow the pace of health improvements for millions of Americans, and harm the American economy. These factors should be kept in mind by Congress and the Administration as they study how best to reform (and, where appropriate, eliminate) FDA regulation of drugs and medical devices. Reducing the burdens imposed on inventors by the FDA would allow more drugs to get to the market more quickly so that patients could pursue new and potentially lifesaving treatments.