Merck’s $58 million consumer fraud settlement with 29 states and the District of Columbia affects a broad swath of pharmaceutical company activities, including advertising and promotion, continuing medical education, drug safety monitoring boards, journal authorship and clinical trial posting. It may set new enforcement standards.
Merck’s recent settlement of consumer fraud claims by State Attorneys General (AGs) represents the latest and perhaps most important reminder to date that regulation of pharmaceutical company practices by the U.S. Food and Drug Administration (FDA) is only one dimension of the current regulatory and enforcement landscape. The State AGs have firmly positioned themselves as potent enforcers in their own right who have the will and the means both to extract significant financial penalties, and perhaps even more importantly, to impose significant going-forward constraints on the pharmaceutical and device industries.
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