Bristol-Myers Squibb Settles Off-Label Promotion Case for $19.5 Million

Late last year, Bristol-Myers Squibb (BMS) settled with the government to resolve allegations that spanned several states that it improperly promoted a schizophrenia treatment for uses not approved by the United States Food and Drug Administration (FDA). The agreement, with a whopping forty-two states (including California, New York, and Texas) and the District of Columbia, focuses on charges that BMS promoted Abilify (an anti-psychotic drug) for use in children and elderly patients with dementia and Alzheimer’s disease. The FDA approved Abilify in 2002 for treating schizophrenic adults. Since then, it has since approved various forms of the drug for other uses. When the alleged improper marketing occurred, such uses were not approved by the FDA. In 2006, Abilify received a “black box” warning stating that it could increase the risk of death for dementia patients. The states further alleged that BMS misrepresented risks that the drug posed to patients, such as weight gain and metabolic side effects, violating consumer protection laws. The agreement prohibits BMS from promoting Abilify for off-label use, making false or misleading claims about it, paying health care providers for merely attending a promotional event for the drug, using medical education grants to promote the drug and rewarding health care providers with grants based on prescribing habits, among other restrictions. “Drug companies should not market their drug for off-label uses or make claims that a...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs