Off-label marketing is the practice of pharmaceutical marketing professionals creating financial incentives and pressuring doctors to prescribe pharmaceuticals for an unapproved uses. In the United States, the Food and Drug Administration Center for Drug Evaluation and Research (CDER) reviews a company's New Drug Application (NDA) for data from clinical trials to see if the results support the drug for a specific use or indication. If satisfied that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route of administration, and other information to be included on the drug's label. More detail is included in the drug's package insert.
The Federal Food Drug and Cosmetic Act (”FDCA”), provides a specific regulation process for the approval of new drugs and new drug formulations intended to be marketed for use in interstate commerce. Under the FDCA, a new drug product cannot be marketed unless the FDA approves the product and determines that it is safe and effective for its intended use. When the FDA approves a drug, it approves the drug only for the particular use for which it was tested, but after the drug is approved for a particular use, the FDCA does not regulate how the drug may be prescribed by doctors. Thus, a drug that has been tested and approved by the FDA for one use only can also be prescribed by a physician for another use, known as off-label. Though physicians may prescribe drugs for off-label usage, the FDA prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved.
In the past ten years some pharmaceutical marketing departments have found it extremely profitable to market their drug for non-FDA approved uses. The FDA's inability to regulate physicians allowed the drug company marketing departments and drug representatives to set up elaborate schemes to encourage physicians to prescribe drugs for off-label uses including misleading doctors as to the efficacy of a drug for a particular treatment and forms of kickbacks including vacations, conferences, initial free samples, hiring physician's families.
Penalties for Off-Label Drug Marketing and Whistleblower Rewards for Stopping Off-Label Pharmaceutical Marketing
Pfizer has paid a total of $2.75 billion in off-label penalties since 2004 which is a little more than 1 percent of the company’s revenue of $245 billion from 2004 to 2008.
JUSTICE DEPARTMENT ANNOUNCES LARGEST HEALTH CARE FRAUD SETTLEMENT IN ITS HISTORY
Pfizer To Pay $2.3 Billion For Fraudulent Marketing
WASHINGTON – American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together “Pfizer”) have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today.
Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005. Under the provisions of the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – i.e., any use not specified in an application and approved by FDA. Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns. The company will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion.
In addition, Pfizer has agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs. The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170. This is the largest civil fraud settlement in history against a pharmaceutical company.
Pharmaceutical Marketing Executives, Drug Representatives, Lawyers, Hospital Administrators, Health Care Professionals, Accountants, Benefit Coordinators, Drug Representatives, Marketing Professionals, Physicians as Health Care Fraud and Qui Tam Whistleblowers Are Stepping Forward to File Health Care Billing Fraud Law Suits (Off-Label Pharmaceutical Whistleblower Qui Tam Law Suits)
Through Whistleblower Lawsuits, Qui Tam Lawsuits, and other Health Care Fraud Lawsuits, hundreds of billions of dollars have been recovered from individuals and organizations that have committed health care fraud and stolen large amounts of money from the government. It is extremely important that Whistleblowers continue to expose fraud schemes, off-label marketing schemes, illegal kickbacks, fraudulent billing practices and unnecessary treatments that cost hundreds of billions of dollars. For more information on this topic including Off-Label Drug Medicare Fraud Lawyers, go to the following web page Off-Label Pharmaceutical Medicare Fraud Whistleblower Lawsuits.
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