OFF-LABEL MARKETING OF PRESCRIPTION DRUGS

Several pharmaceutical whistleblower lawsuits have alleged  that pharmaceutical manufacturers engaged in ”off-label marketing.” Off-label marketing is a type of pharmaceutical fraud that occurs when a pharmaceutical manufacturer promotes its drugs for uses not approved by the Food and Drug Administration (FDA).

When the FDA approves a drug, it approves the drug only for the particular use for which it was tested. In other words, the medication is approved to treat a specific medical condition. The United States Food, Drug and Cosmetic Act (FDCA) establishes the framework for regulation of, inter alia, the sales and marketing activities of pharmaceutical manufacturers in the United States, including the introduction of new drugs into interstate commerce.  While a physician may prescribe a drug for a use other than the one for which it is approved, the FDCA prohibits a drug manufacturer from marketing or promoting a drug for non-approved uses. It therefore is illegal for a drug manufacturer and its sales representatives to promote or initiate discussions with medical professionals regarding any off-label use of a drug.

Federal health care programs such as Medicare and Medicaid generally do not pay for drugs prescribed for off-label use. Therefore, pharmaceutical fraud is committed when drug manufacturers cause claims for off-label medications to be reimbursed by Medicare Part D or Medicaid. The basic premise of the claim of off-label marketing is that the manufacturer has committed pharmaceutical fraud upon the federal government and is liable under the civil False Claims Act because it knowingly engaged in the off-label promotion of its prescription drugs, and received payments from government health care programs (Medicare, Medicaid and Tricare) as a result of such off-label promotion.

No Fees Without Recovery

Ross M. Wolfe and the Weiser Law Firm litigate whistleblower lawsuits on a contingent fee basis, so whistleblowers do not pay attorneys’ fees or court costs unless there is a recovery.

Please contact Ross M. Wolfe if you would like to speak with a whistleblower attorney for more information about the whistleblower process, off-label marketing, pharmaceutical fraud or to schedule a free consultation to confidentially discuss your potential case.

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