Healthy Skepticism Library item: 7558

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.
Regulators and legislators address pharmaceutical rules and coverage - FDA offers new policies to relate enforcement to product risk
Formulary 2003; 38:(10):606-7

Abstract:

This article discusses the plan by FDA to achieve more timely and efficient review and approval of new products and to relate regulation enforcement to product risk. The plan is said to provide more guidance for manufacturers to clarify development pathways for new therapies, particularly for emerging technologies such as genomics and combination products. An important aspect of risk management outlined in the strategic plan is to provide the public with more information on medical products in order to reduce risks associated with inappropriate drug use. To facilitate public access to high-quality and effective medical products, the plan also emphasizes the need for FDA to be more flexible and efficient in regulating pharmaceutical manufacturing and quality control. These initiatives to streamline FDA regulations and bring new therapies to market more efficiently should help to reduce the cost of pharmaceuticals and improve access to healthcare. This concept is attractive to legislators seeking to establish an affordable Medicare prescription drug benefit.