Healthy Skepticism Library item: 9300

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

Kale MV, Sharp WT, Cady PS, Adamcik BA.
FDA: can it keep up with the times ahead?
1994 Mar; 141:153

Abstract:

This study examines the regulatory process pertaining to the promotion of prescribed medication since changes were initiated in statutes and regulations controlling the promotion of prescription products. The role of the Food and Drug Administration (FDA) and its success with the regulatory process was analyzed using unpublished data from the FDA. Specifically, annual reports, notice of violation letters and regulatory letters issued for advertising violations were examined. The analysis revealed that both the number of notice of violation letters and regulatory letters have increased during the time period between 1975 and 1992 (p\LT/.05). An index of satisfaction developed by the FDA also confirmed an increase in the FDA regulatory process. Trends concerning violations in the regulatory process and the potential lack of enforcement in the regulatory process are included. Future implication for and alternative regulatory strategy are discussed.