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Pharmaceutical Fraud

PharmaFraud

Pharmaceutical fraud encompasses a wide array of white collar offenses, all of which are considered serious crimes in Florida. If you have been accused of receiving illegal kickbacks, marketing drugs for off label uses, or of committing Medicaid fraud, you should contact an experienced white collar crime attorney who can evaluate your case.

Federal Law

Pharmaceutical fraud is one of the most common types of fraud pursued by federal prosecutors under the False Claims Act (FCA). Under the FCA, government contractors and pharmaceutical companies can be held liable for the following types of offenses:

  • Medical trial fraud, which occurs when pharmaceutical manufacturers give false data to the Food and Drug Administration (FDA) or withhold negative data obtained from clinical research about the drug’s effectiveness or side effects in order to obtain FDA approval;
  • Failure to report adverse side effects discovered after a drug was already approved or marketed;
  • Failure to comply with the Current Good Manufacturing Practice regulations, which require manufacturers to use specific production practices that will prevent instances of contamination during production, packaging, and shipping;
  • Intentionally deceiving investigators regarding manufacturing facilities or processes;
  • Violating federal laws that regulate drug sales, which could include selling drug samples, reselling medication already purchased by another health care entity, or distributing wholesale prescription drugs without a state license;
  • Paying kickbacks or providing valuable incentives to physicians, hospitals, or pharmacists in exchange for agreeing to prescribe or switch drugs;
  • Failing to give discounts to qualified health care providers that serve uninsured or disadvantaged patients;
  • Promoting the use of prescription drugs for unapproved purposes;
  • Failing to report pricing data to the Centers for Medicare and Medicaid Services (CMS); and
  • Failing to report a drug’s status, price, or drug origin.

Penalties and Defenses

Companies or individuals convicted of committing pharmaceutical fraud can be required to pay millions of dollars in damages. However, a person may be able to have his or her damages reduced if he or she:

  • Provided all information known to him or her about the violation to investigators within one month of receiving the information;
  • Fully cooperated with government investigations; and
  • Provided the information before a criminal prosecution, civil action, or administrative claim had commenced and was not aware of the investigation.

Furthermore, a person can only be convicted of pharmaceutical fraud if he or she:

  • Had actual knowledge of the information;
  • Acted in deliberate ignorance of the truth or falsity of the information; or
  • Acted in reckless disregard of the truth or falsity of the information.

However, prosecutors will not need to demonstrate that a person had the specific intent to commit the fraudulent act in order to obtain a conviction.

Contact an Experienced White Collar Crime Attorney Today

Being charged with pharmaceutical fraud can have devastating consequences. If you are under investigation for fraud, please contact our legal team at the South Florida law firm of Jeffrey S. Weiner, P.A by calling 305-670-9919 and we’ll help you schedule a free consultation with a dedicated white collar crime attorney who can help explain your legal options.

Resources:

law.cornell.edu/uscode/text/31/3729

fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm

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