title: Pharmaceutical marketing practices: balancing public health and law enforcement interests; moving beyond regulation-through-litigation.
abstract: Fraudulent or abusive sales and marketing practices by pharmaceutical companies can result in costly overutilization of products that are increasingly paid for by government healthcare programs and may result in adverse health and safety consequences to the patient-beneficiaries of those programs. Federal enforcement efforts in this area are largely modeled on those used to combat white-collar crime, with cases taking years to reach conclusion. This approach overlooks the impact on patients who receive unnecessary care or are denied access to appropriate care during the course of the investigation. Many states are beginning to regulate certain pharmaceutical sales and marketing practices, but state-by-state regulation ignores the importance of a uniform federal regulatory and enforcement approach in an area already occupied by federal law. This Article explores current federal and state efforts to limit overutilization, fraud, and abuse in the sale and marketing of prescription drugs, and illustrates the merits of an expanded role for the U.S. Food and Drug Administration (FDA) to regulate pharmaceutical sales and marketing practices. This approach borrows lessons learned from the FDA's efficient and effective regulatory and enforcement methods and maintains a careful balance between the interests of patient-beneficiaries, the government and industry.
authors.affiliation: World Wide Health Care Compliance, Johnson & Johnson, USA.
authors.forename: Christopher D
authors.initials: CD
authors.lastname: Zalesky
mesh_terms: D004345:Drug Industry; D005607:Fraud / Q000517:prevention & control; D033161:Government Regulation; D040541:Marketing / Q000331:legislation & jurisprudence* / Q000379:methods; D011634:Public Health; D014481:United States; D014486:United States Food and Drug Administration