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Abstract

Numerous recent deaths have been linked to government-approved prescription medicines which revealed no toxic effects during pre-market tests. Governments want to mandate a legal post-marketing surveillance program which would monitor and scrutinize individual drugs over their life cycle. The industry is divided in its response. Some executives refer to the proposed action as “overkill” while others simply anticipate more government regulations. A third group endorses the efforts of government as a positive step in mitigating public fears before they become epidemic.

This paper focuses on this struggle within the industry and between the industry and government. Research was undertaken to examine industry reaction to government surveillance systems and to analyze the results within a framework of coping behavior. In addition, relationships are drawn between market structure and corporate response, and between government-mandated responsibility to consumer concerns and industry's numerous stakeholders.

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Post-Marketing Surveillance in Pharmaceuticals: Reactions

Abstract

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References