List of off-label promotion pharmaceutical settlements

List of Off-Label Promotion Pharmaceutical Settlements

The List of Off-Label Promotion Pharmaceutical Settlements refers to legal actions and financial settlements involving pharmaceutical companies that have been accused of promoting their drugs for off-label uses, which are uses not approved by the Food and Drug Administration (FDA). Off-label promotion is a controversial and heavily regulated aspect of pharmaceutical marketing, as it can lead to the prescription of drugs for conditions without sufficient evidence of safety or efficacy. This article provides an overview of notable settlements in the United States related to off-label drug promotion.

Overview

Off-label use of pharmaceuticals refers to the practice of prescribing drugs for an unapproved indication, age group, dosage, or route of administration. While healthcare providers may legally prescribe drugs off-label, pharmaceutical companies are prohibited from promoting their products for such uses. The FDA regulates drug approval and off-label promotion to ensure that all marketed drugs are safe and effective for their intended uses. Violations of these regulations have led to numerous legal actions against pharmaceutical companies, resulting in significant financial settlements and changes in marketing practices.

Notable Settlements

Pfizer

In 2009, Pfizer agreed to a $2.3 billion settlement, the largest healthcare fraud settlement at the time, for the off-label promotion of four drugs, including Bextra, an anti-inflammatory drug. The settlement also included a guilty plea to a felony violation for misbranding Bextra with the intent to defraud or mislead.

GlaxoSmithKline

GlaxoSmithKline (GSK) settled for $3 billion in 2012, the largest healthcare fraud settlement in U.S. history to that date, for the off-label promotion of several drugs, including Paxil and Wellbutrin, and for failing to report safety data about Avandia to the FDA.

Eli Lilly

Eli Lilly and Company agreed to a $1.415 billion settlement in 2009 for the off-label promotion of Zyprexa, an antipsychotic medication. The settlement included a $515 million criminal fine, the largest ever in a healthcare case at the time.

Johnson & Johnson

In 2013, Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, Inc., agreed to a $2.2 billion settlement for the off-label promotion of Risperdal, an antipsychotic drug, and other medications.

Regulatory and Legal Framework

The FDA's Office of Prescription Drug Promotion (OPDP) is responsible for overseeing the marketing practices of pharmaceutical companies to ensure compliance with federal regulations. The Department of Justice (DOJ) has also played a significant role in prosecuting cases of off-label promotion under the False Claims Act, which allows for significant financial penalties and the recovery of damages to the government.

Impact

The settlements related to off-label promotion have led to increased scrutiny of pharmaceutical marketing practices, the implementation of corporate integrity agreements (CIAs), and the establishment of more stringent guidelines for the promotion of prescription drugs. These actions aim to protect public health by ensuring that drugs are marketed and prescribed based on sound scientific evidence.

See Also

• Pharmaceutical fraud
• Regulation of therapeutic goods
• Food and Drug Administration
• False Claims Act