had the cumulative effect of creating a negative marketing image for the industry at large. Meanwhile, enforcement letters were viewed in some companies simply as an annoying but tolerable penalty that justified the business risk of undertaking aggressive promotion campaigns. In the late 1990s and into this century, new players entered the enforcement/legal picture. US federal and state governments' efforts to prevent fraud and abuse in Medicare and Medicaid programs led to a flurry of highly publicized settlements with medical products companies that cost billions of dollars in fines and required the adoption of stringent internal compliance programs. These actions stemmed primarily from two types of allegations—one was the misrepresentation by companies of their pricing information and practices, and the second was the off-label promotion of products that are purchased or reimbursed by the government. The new cases have been brought under three distinct laws: the False Claims Act, the Anti-Kickback Statute, and the Food, Drug & Cosmetic Act (FD&C Act). The first two laws include provisions for significant penalties for causing false claims for payment to be presented to the government or for providing inappropriate inducement to prescribe. Until the mid-to-late 1990s, the False Claims Act and the Anti-Kickback Statute had not been applied to the pharmaceutical and medical devices industries. The application of these statutes by the Department of Health and Human Services' (HIIS) Office of the Inspector General (OIG) and the Department of Justice, plus the states (many of which adopted their own false claims laws), raised the stakes for industry considerably. These laws can lead and have led to far greater penalties than those authorized under the FD&C Act. The use of the False Claims Act for enforcement has caused particular strife within some companies, as it
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