A Time for Change in Advertising and Promotion Regulation

Abstract

The election of a Republican Congress in November 1994 signaled a change in how the country views the role of the Federal Government. The Food and Drug Administration (FDA) will be a principal target for regulatory reform. The Republicans see the mission of the FDA as proactive, advancing the availability of new medical products, not just protecting the public from unsafe or ineffective ones. The main focus will be on the drug and device approval processes. The FDA approval processes have faced debate and controversy numerous times in the past three decades. Major change is unlikely; continued incremental change will likely be the result of 1995's debates in Congress. This will also be a time to look at how information systems about drugs are functioning. The world is a much different place than it was when the 1962 Drug Amendments were passed. There are four incremental changes proposed. They do not fundamentally alter how FDA goes about regulating advertising and promotion. They are intended to make the system more rational and open.