Enforcing Integrity is a new article by Professor Katrice Bridges Copeland in 87 Indiana Law Journal (2011)  

Abstract:
Over the past several years, the marketing practices of large pharmaceutical companies have come under intense scrutiny. The government spends years investigating and building cases against pharmaceutical manufacturers that engage in illegal promotional activities to promote their drugs but does not prosecute them. Instead, the government enters into Corporate Integrity Agreements (CIAs) with the pharmaceutical giants. As a result, the pharmaceutical manufacturers are able to avoid the collateral consequences of conviction, such as exclusion from Medicare and Medicaid. Participation in Medicare and Medicaid is crucial for a pharmaceutical manufacturer because the government spends over $60 Billion per year through those programs on reimbursements for prescription drugs. In return for remaining eligible for Medicare and Medicaid reimbursements for their drugs, the manufacturer pays the government a huge fine and agrees to structural changes to the company designed to prevent future marketing violations.

The CIA seems like a reasonable response to the marketing violations until the pharmaceutical company engages in illegal marketing practices while still under the CIA for the previous marketing violation. In those situations, the government remains unwilling to pursue the pharmaceutical manufacturers in court and seek exclusion from Medicare and Medicaid. Rather than pursue exclusion, the government has entered into successive CIAs with pharmaceutical manufacturers and collected additional fines. The government enters into these agreements because exclusion of the manufacturer from participating in Medicare and Medicaid has devastating consequences that spill over to innocent patients, employees, and stockholders. Not only does the impact of the exclusion hit innocent third parties, but its imposition on the manufacturer substantially outweighs the harm the manufacturer inflicts through its improper marketing practices. The penalty for improperly marketing one drug is exclusion of all drugs produced by that manufacturer from Medicare and Medicaid. It is the government’s unwillingness to harm innocent third parties and its reluctance to impose a disproportionate penalty on drug manufacturers that leads them to CIAs. Thus, the problem is not that the government uses CIAs to combat health care fraud; it is that the government lacks penalties of increasing severity to impose when a manufacturer violates an existing CIA.

This Article argues that neither the exclusion of manufacturers from Medicare and Medicaid nor the use of Corporate Integrity Agreements coupled with large fines is an effective deterrent for pharmaceutical manufacturers that repeatedly engage in illegal marketing activities to promote their drugs. In particular, it argues that CIAs fail to deter drug manufacturers from engaging in illegal promotional practices because the penalty imposed and the cost of compliance with the CIA are significantly lower than the profits that a pharmaceutical company can obtain by illegally marketing its drugs. Further, the government’s willingness to enter into multiple CIAs with repeat offenders of the marketing rules rather than exclude them from Medicare and Medicaid substantially diminishes the ability of CIAs to deter illegal promotional activities. Finally, this Article argues that there are viable alternatives to be used in place of or in conjunction with CIAs, such as funding clinical trials, compulsory licensing, corporate officer liability, and targeted exclusion, that would be more effective deterrents for repeat offenders. Each of these remedies could be used to increase the severity of punishment when a one-time offender becomes a repeat offender. This Article concludes that these proposed measures would be more successful than CIAs at increasing compliance and enforcing integrity in drug promotion.

(esp)