FDA Fraud Defense
Federal Defense Lawyers for FDA Office of Criminal Investigations (OCI) Matters
The Office of Criminal Investigations (OCI) is the law enforcement division of the U.S. Food and Drug Administration (FDA). The OCI investigates manufacturers, testing laboratories, healthcare providers, and other business entities and individuals for a broad range of fraud-related offenses, and it aggressively pursues criminal charges under several federal statutes. If you are being targeted in an OCI investigation involving allegations of FDA fraud, it is important that you speak with a federal defense lawyer as soon as possible.
Our firm provides FDA fraud defense representation for corporate and individual clients nationwide. Our attorneys handle cases involving all matters falling within the OCI’s criminal enforcement jurisdiction, from individual healthcare provider fraud to large-scale conspiracies and “fraudulent schemes” related to FDA approvals and large-scale product substitutions. In our experience, prompt intervention and proactive defense are critical to mitigating the risk of prosecution. We offer emergency representation for FDA fraud investigations when necessary, and we are able to efficiently represent clients in OCI matters across the country.
The OCI’s “Expanding Footprint” for FDA Fraud Enforcement
In recent years, the OCI has been ramping up its FDA fraud enforcement efforts. Its “expanding footprint” now includes 43 field, resident, and domicile offices across the country (in addition to its headquarters in Washington D.C.), and it also has agents located in Singapore and the Hague that assist in cross-border investigations involving allegations of counterfeiting and other fraud-related crimes. Currently, the OCI has field and resident offices located in:
- Atlanta, GA
- Boston, MA
- Chicago, IL
- Dallas, TX
- Kansas City, MO
- Los Angeles, CA
- Miami, FL
- New Orleans, LA
- New York, NY
- Philadelphia, PA
- San Francisco, CA
- San Juan, Puerto Rico
- Washington D.C.
The OCI’s domicile offices are located in various cities spread across: Alabama, Arizona, Colorado, Florida, Hawaii, Kentucky, Michigan, Minnesota, Nebraska, Nevada, New Hampshire, New York, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, and Washington.
Investigative Priorities and FDA Fraud Initiatives Currently Being Pursued by the OCI
The OCI has identified a number of investigative priorities within the broader area of FDA fraud enforcement, and it is continuing to target companies and individuals suspected of other fraud-related criminal offenses as well. With this in mind, allegations that are likely to trigger criminal FDA fraud investigations include:
Healthcare Fraud Scams
The FDA’s Office of Criminal Investigations is actively targeting healthcare providers and others suspected of having involvement in scams that involve, “products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses.” This includes specifically, but not exclusively, “schemes involving ineffective AIDS, cancer, and Alzheimer cures.”
In fact, combatting healthcare fraud is a major component of the FDA’s and OCI’s overall fraud crackdown efforts. Other common allegations against physicians, physician groups, pharmacies, clinics, laboratories, and other entities and individuals in the healthcare sector include:
- The offering, payment, solicitation, and receipt of unlawful kickbacks, rebates, and referral fees
- Fraudulent compounding of prescription medications
- Participating in fraudulent schemes to secure FDA approval
- Conspiracies related to the marketing, sale, and distribution of non-FDA-approved medications and medical devices
- Billing Medicare, Medicaid, Tricare, the Veterans Administration (VA) and other benefit programs for non-FDA-approved medications and medical devices
Breaches in the Legitimate Medical Supply Chain
The OCI’s current list of investigative priorities includes, “[b]reaches in the legitimate medical supply chain by individuals and organizations dealing in unapproved, counterfeit, and substandard medical products.” This includes fraudulent practices in all stages of the chain of distribution, and doctors, pharmacists, and other providers can face FDA fraud allegations even if they are unaware (but should have been aware) of a medication’s or medical device’s non-approved status.
Non-Compliance with Regulatory Enforcement Efforts
The OCI is also currently placing particular emphasis on, “[c]riminal violations in situations where the normal regulatory process has been unable to remedy the problem.” In other words, companies and providers that fail to comply with the FDA’s administrative and civil enforcement efforts are at increased risk for facing criminal prosecution by the OCI. As a result, entities and individuals must not simply ignore administrative and civil inquiries from the FDA, as doing so is extremely unlikely to lead to a favorable result and is actually more likely to enhance their risk of facing a criminal investigation.
Significant Risk of Harm to Public Safety
Another of the OCI’s current investigative priorities involves targeting entities and individuals for prosecution in cases where, “the risk of harm to the public health is particularly significant and the only remedy appears to be through the criminal process.” This includes, but is by no means limited to, cases involving non-FDA-approved medications and medical devices, prescription drug diversion schemes, and other schemes which result in patients receiving either substandard or inappropriate medical treatment. These cases tend to progress particularly quickly, and this makes promptly engaging experienced federal defense counsel of utmost importance.
False Statements to the FDA and Obstruction of Justice
The OCI’s fourth investigative priority is focused on prosecuting, “[c]riminal conduct that prevents the FDA from being able to properly regulate. This includes false statements to the FDA during the regulatory process and obstruction of justice.” Investigations in this category can implicate the criminal provisions of a variety of different federal laws, including the Food, Drug, and Cosmetic Act and the obstruction of justice statute (18 U.S.C. § 1503).
Distribution of Counterfeit, Unapproved, and Misbranded Medical Products
The OCI routinely conducts investigations targeting allegations of FDA fraud in the form of distribution of counterfeit, unapproved, and misbranded medical products. This includes pharmaceutical medications as well as external and implantable medical devices.
While counterfeiting investigations often involve the importation of foreign products and are less likely to target legitimate healthcare providers, licensed pharmacists and physicians must be extremely careful to avoid facing criminal sanctions in cases where they are alleged to have distributed unapproved or misbranded products. These types of cases are far more common, and pharmaceutical and medical device companies do not always supply providers with complete and accurate information.
Illicit Drug Diversion
Combatting the diversion of opioids and other prescription medications is a top law enforcement priority for the FDA, the Drug Enforcement Administration (DEA), the U.S. Department of Justice (DOJ), and multiple other federal agencies. In OCI investigations involving allegations of illicit drug diversion, a coordinated and effective defense strategy is critical to avoiding substantial penalties for FDA fraud and potentially a multitude of other federal crimes.
Large-Scale Product Substitution
Large-scale product substitution investigations target the marketing and distribution of biosimilar non-FDA-approved medical products and other products that are interchangeable with FDA-approved products. While exemptions are available under certain circumstances, selling non-approved products without the necessary FDA exemption is potentially a serious federal offense.
FDA Approval Application and Clinical Investigation Fraud
Fraudulent practices in connection with FDA approval applications and clinical investigations can in some cases lead to criminal charges. The OCI investigates a broad range of offenses in this category, from the fraudulent alteration of clinical test results and falsification of other application data to bribery of clinical investigators and trial volunteers.
Experienced Federal Defense Lawyers for Criminal FDA Fraud Investigations
With our firm’s broad-based experience in federal criminal investigations, and with our focus on representing clients in federal matters, we offer strategic representation and deep insights for fending off criminal charges during FDA fraud investigations. With several attorneys who previously oversaw fraud investigations and prosecuted criminal fraud charges on behalf of the DOJ, we are well-equipped to help our clients make informed decisions focused on avoiding federal charges.
When you engage Oberheiden, P.C. as federal defense counsel for your FDA fraud investigation, our attorneys will:
- Meet with you confidentially to discuss the investigation, preliminarily assess your potential exposure (if any), and determine your next steps.
- Communicate with the FDA or OCI to gather critical information about the investigation and ensure that all future correspondence will be directed to our attorneys.
- Identify all potential defenses and work collaboratively with you to develop a comprehensive and cohesive defense strategy.
- Execute our defense strategy while constantly assessing new opportunities to secure a favorable result in light of developments during the investigation.
- Pursue all available opportunities to favorably resolve your FDA fraud investigation without criminal charges being filed.
Investigations that begin as civil inquiries can quickly turn criminal in nature, and even the civil penalties for FDA fraud can be crippling for companies and healthcare practices of all sizes. As a result, regardless of the current stature of the FDA’s or OCI’s investigation, it is advisable to engage federal defense counsel immediately. If you have received a subpoena, or if you have been contacted by the FDA or OCI regarding an investigation by any other means, contact us now to speak with one of our federal defense lawyers in confidence.