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.
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 Kickback Claims and Pharmaceutical Kickback Lawsuits
The pharmaceutical industry has been extremely successful in making large profits by marketing off-label uses of their drugs. Recently, drug representatives, marketing executives, and other whistleblowers have come forward to expose fraudulent practices ranging from fraudulent pricing issues to sales and aggressive marketing practices. Qui tam pharmaceutical fraud cases are expected to continue well into the future as the penalties for off-label marketing have not been enough to prevent big pharmaceutical companies from making large profits on fraud off-label marketing practices.
Health Care Billing Fraud Law Suits (Fraud Costs Tax Payers and Consumers Hundreds of Billions of Dollars)
Health Care Expenses in the United States have increased to be over Two Trillion ($2,000,000,000,000.00) Dollars each year. This amount continues to rise as many unnecessary procedures and treatments are performed as well as unscrupulous health care provided fraudulently billing for medical services that are never performed committing billing fraud, insurance fraud, double billing, and other health care fraud that costs hundreds of billions of dollars.
From a taxpayer stand point, health care fraud costs taxpayers between $60 billion and $100 billion each year. This cost increases dramatically when you include other forms of health care fraud including insurance fraud and fraud on patients.
Anti-Kickback Claims Against Health Care Providers
In 1972, the United States Congress passed the anti-kickback statute which made it illegal for providers, including doctors, to knowingly and willfully accept bribes or other forms of remuneration in return for generating Medicare, Medicaid or other federal healthcare program business. The federal anti-kickback law's main purpose was to protect patients and federal health care programs from fraud and abuse by curtailing the corrupting influence of money on health care decisions. The legislation prevents payoffs to those who have the power to influence health care decisions. This prohibition removes potential economic incentives that could influence health care providers to refer or recommend medical goods and services that are medically inappropriate, medically unnecessary, of poor quality, or even harmful to a vulnerable patient population. This legislation protects federal health care programs from difficult to detect kickback referrals and services as well as works with other laws to provide incentives for whistle blowers that are aware of medical providers that are wrongfully taking money to benefit from disclosing these unlawful kickbacks.
The Anti-Kickback statute prohibits any person or business entity from making or accepting payment to induce or reward any person for referring, recommending or arranging for the purchase of any item or service for which payment may be made under a federally-funded health care program. The statute prohibits kickbacks, bribes, inducements, rewards, and other economic incentives that induce physicians to refer patients for services or recommend purchase of medical supplies that will be reimbursable under government health care programs.
Health Care Provider claims for reimbursement to federal health care programs for services or medical supplies that are the result of bribes, kickbacks, or other economic incentives are false claims and are subject to potential Federal Health Care Program False Claim Lawsuits including Federal Anti-Kickback Statute Lawsuits, Federal Health Care Program Referral Claim Lawsuits, and Federal Health Care Program Medical Supply Bribery Claim Lawsuits.
Failure of a health care provider to comply with the Anti-Kickback Statute is a precondition to participation in federal health care programs and violations of the Anti-Kickback Statute can result in loss of funding, payments, and reimbursements from Medicare, Medicaid, and other Federal Health Care Programs.
For more on the Anti-Kickback Statute, please go to the following webpage, Whistleblower Anti-Kickback Statute Qui Tam Lawsuits.
Hospital Administrators, Health Care Professionals, Accountants, Benefit Coordinators, Drug Representatives, Marketing Professionals, Physicians as Health Care Fraud and Qui Tam Whistleblowers 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. If you are aware of a large health care company or individual that is defrauding the United States Government out of millions or billions of dollars, feel free to contact Off-label Pharmaceutical Marketing Fraud lawyer Jason Coomer. For more information on False Claims Act Qui Tam Lawsuits, please go to the following website or webpage.
