The advocacy role of regulatory agencies.

Most governments contain agencies with legal responsibility for: 1) assuring that drugs and medical devices have been proved safe and effective before they are made available to the public and 2) monitoring drugs and devices in use to assure their continued safety and efficacy. It is postulated that in addition to these two essential responsibilities regulatory agencies have a third responsibility which is to be advocates for the development of new drugs and devices that hold promise for improving human welfare. The need for such advocacy applies particularly to the development of new safe and effective methods of fertility regulation. Effective advocacy requires the best possible scientific talent expeditious review of applications derivation of decisions openly and free collaboration with professional groups consumer groups other government regulatory agencies and international organizations particularly the WHO. Advocacy is defined as the active and explicit encouragement of research development and ultimate registration of new drugs and devices. Examples of such advocacy are provided. (authors)