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Defending Against FDA Investigation

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FDA Investigation Defense Lawyers

The health care system is one of the most complex and densely regulated systems in existence, making it is easy to run afoul of both civil and criminal laws. Over the past several years, the Office of Criminal Investigations of the U.S. Food and Drug Administration (FDA) has been aggressively investigating physicians and pharmaceutical manufacturing companies, as well as other actors in the health care industry.

FDA Harassment

FDA criminal investigations are anything but routine. The Office of Criminal Investigations (OCI) has a budget of over $77 million and a number of officers who were recruited directly from the Secret Service. Physicians, and sometimes even FDA investigators themselves, have been complaining that the FDA conducts overreaching and often illegal searches and seizures along with other aggressive “cowboy tactics” designed to intimidate investigation targets. Many of these investigations do not even result in actual prosecutions. Investigations that do result in prosecutions often leave behind devastated lives and bankrupt practices.

The Regulatory Landscape

Unfortunately, some health care statutes and regulations have been drafted so strictly that the government can successfully prosecute you without even having to prove that you acted with any form of criminal intent. In addition to prison time, you might also face fines, disgorgement of profits, or loss of your professional license. Some of the most common statutes that are likely to underlie FDA criminal investigations include:

  • The Federal Food, Drug, and Cosmetic Act
  • The False Claims Act
  • The Federal Anti-Tampering Act
  • The Prescription Drug Marketing Act

In addition to the statutes listed above (along with many others), hundreds of thousands of detailed regulations have been authorized under these statutes. Manufacturers, distributors, importers, exporters, and health care providers (including individual physicians) are all at risk of coming under the FDA’s piercing scrutiny.


Suspicions that commonly triggers FDA criminal investigations include:

  • False statements to the FDA
  • The procurement of unapproved or counterfeit medical products
  • Repeated and serious violations of FDA regulations, especially where bad faith is suspected
  • Promotion of “off-label” uses of pharmaceuticals and other medical products
  • Fraudulent treatments
  • False statements on pharmaceutical approval applications
  • Fraudulent clinical trials
  • Illegal manufacturing or sale of unapproved medical products
  • Failure to comply with FDA-approved manufacturing processes
  • Obtaining unapproved foreign-sourced drugs, such as Botox
  • Accepting direct or indirect “kickbacks” for prescribing certain drugs or for performing or recommending certain other actions
  • Illegal pharmaceutical compounding

Once you learn that an FDA investigation has been initiated against you, every decision matters, because every action that you take generates important consequences.

Fighting Back

If you have come under FDA investigation, or if you anticipate such an investigation, do not hesitate to contact Oberheiden, P.C. by calling 1-888-727-0472 or by contacting us online. Since we practice federal law, it doesn’t matter where you are in the United States – we can effectively represent you.

Our team of former federal prosecutors, experienced criminal defense counsel, and a forensic fraud examiner deeply understand the FDA investigatory and prosecutorial landscape, and we possess the knowledge and experience to effectively pursue our singular goal: Complete dismissal of your case. Contact us immediately to schedule a free initial consultation.

Orange County 714-294-2000
Los Angeles 310-873-8140
Detroit 313-888-8807
Nationwide 888-452-2503