Healthy Skepticism Library item: 10530

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

Achanta AS.
OTC switch case history evaluation: NicoretteR
Clinical Research and Regulatory-Affairs 2003; 20:(1):15-26

Abstract:

As part of the FDA’s current review of its regulatory approach to nonprescription medicines, it is necessary for stakeholders to contribute to the ongoing discourse. Reclassification of prescription medicines to over-the-counter status is an important topic attracting the attention of many in the United States and elsewhere. This article presents a detailed examination of FDA’s application of switch regulatory policy, the use of innovative consumer communication and education tools in the OTC environment and overall public health impact of the switch using the Nicorette case as an example. Post switch evidence shows that OTC reclassification of Nicorette achieved the anticipated goal of balancing increased access with decreased control in the OTC atmosphere resulting in a positive public health outcome in the area of smoking control.