A NY Criminal Attorney Explains Off Label Marketing Fraud
Before a drug is released to the marketplace, an application must be submitted to the Food and Drug Administration and the medication must go through extensive safety testing. When drugs are approved, they are approved for particular purposes and for particular patient groups. Promoting the use of a medication for unapproved symptoms or conditions, in unapproved doses, or for unapproved groups of patients is considered to be a form of marketing fraud.
Defendants who are accused of off-label marketing fraud may face criminal prosecution, which can result in incarceration. Claims may also be made under the False Claims Act, which can result in significant financial consequences for the defendant accused of the illegal marketing practices. Bukh Law Firm, PLLC provides legal representation to defendants who have been accused of off-label marketing offenses. We will develop a comprehensive legal strategy to address all civil and criminal actions brought under state or federal law. Call as soon as possible to speak with a NY criminal attorney to determine how best to respond to accusations with the goal of minimizing or avoiding criminal penalties and financial loss.
When a medication is approved by the FDA, the on-label use, or “indication” and the approved dosage is specified and the drug may only legally be prescribed for these particular purposes. To promote a medication for other use, the manufacturer must submit a Supplemental New Drug Application and the drug must undergo a new set of clinical trials.
The Food, Drug, and Cosmetic Act (FDCA) strictly prohibits manufacturers from promoting a drug in any way for a use not approved by the FDA. Any marketing or promotional materials which describe any use for the drug not approved by the FDA can constitute off-label marketing. Illegal behaviors that are considered off-label marketing fraud could include:
- Providing medical literature to sales representatives or physicians endorsing off-label use or describing any potential benefits the drug could have when used for purposes other than the approved indication.
- Publishing information on a company website or in any other literature suggesting health benefits of using the drug for an off-label use.
- Training sales representatives in any way about dosages or uses for the drug which are not approved by the FDA.
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- Providing kickbacks, payments, or any financial incentive to physicians to prescribe the drug for off-label use.
- Paying physicians to promote off-label use of drugs at conferences, speaking arrangements, or in any other form.
In these and other situation, companies and individuals responsible for the off-labeling marketing fraud can be held accountable and face serious legal consequences for violating federal law.
Defendants who engage in off-label marketing fraud can face federal criminal charges for pharmaceutical fraud.
Centers for Medicare & Medicaid Services (CMS) makes clear that promoting of off-label uses for medication can cause Medicaid and Medicare to be billed for off-label use. This means defendants could be charged with a felony criminal offense under 42 U.S. Code Section 1320-a-7b, which imposes up to a five year prison sentence for causing false statements to be made in connection with an application for benefits or payments under federal health care programs.
The Federal False Claims Act also allows for recovery of money obtained through fraud against the government. FCA Penalties may total three times the damages as well as an additional penalty between $5,500 and $11,000 (adjusted for inflation) for each false claim. A civil lawsuit to recover under the False Claims Act can thus result in millions in penalties for off-label marketing fraud.
Bukh Law Firm, PLLC is here to help individuals and companies accused of off-label marketing fraud. If you are facing civil and criminal actions for allegedly promoting the off-label use of a medication, give us a call to speak with a NY criminal attorney so our experienced legal team can get started putting together an effective defense strategy.