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As FDA defense lawyers, Lowther | Walker has a track record spanning hundreds of federal cases and decades of courtroom experience nationwide. Our team is adept in the complex life sciences regulatory environment. Our representation experience covers all FDA-regulated product types and technologies, including biologics, drugs, and medical devices. We regularly advise on and resolve FDA enforcement actions, including:
FDA Office of Criminal Investigations (OCI) probes
Tampering with medications or consumer products
Importing or distributing unapproved and counterfeit products
Off-label marketing schemes
Clinical trial fraud and data falsification
Severe manufacturing and cGMP violations
Executive liability under the Park Doctrine
No-obligation. Fully confidential.
Call Us Today: (404) 496-4052
Declined Medicare Fraud Prosecution When the government alleges $100 million in fraudulent Medicare reimbursements, the stakes are undeniably high. Recently, our firm successfully represented the former director of a national laboratory targeted by federal authorities […]
Fraud Charges Dismissed In US v. J.C., the DOJ targeted our client, a public official, for their alleged involvement in a conspiracy to fraudulently obtain over $1 million in pandemic subsidies and loans. We dismantled […]
Investigation terminated; no prosecution. DOJ notified our client, the CEO of a major hospital network, that he was the target of a multi-million-dollar healthcare fraud investigation related to “Medicare upcoding” that the FBI and HHS-OIG […]
Investigation terminated; no prosecution. DOJ notified our client that she was the target of a multi-million-dollar public corruption, money-laundering, and tax-fraud investigation that the FBI and IRS-CI were conducting. The client’s former attorney had arranged […]
Declined Medicare Fraud Prosecution When the government alleges $100 million in fraudulent Medicare reimbursements, the stakes are undeniably high. Recently, our firm successfully represented the former director of a national laboratory targeted by federal authorities […]
Fraud Charges Dismissed In US v. J.C., the DOJ targeted our client, a public official, for their alleged involvement in a conspiracy to fraudulently obtain over $1 million in pandemic subsidies and loans. We dismantled […]
Investigation terminated; no prosecution. DOJ notified our client, the CEO of a major hospital network, that he was the target of a multi-million-dollar healthcare fraud investigation related to “Medicare upcoding” that the FBI and HHS-OIG […]
Investigation terminated; no prosecution. DOJ notified our client that she was the target of a multi-million-dollar public corruption, money-laundering, and tax-fraud investigation that the FBI and IRS-CI were conducting. The client’s former attorney had arranged […]
When the DOJ Consumer Protection Branch, the FDA’s Office of Criminal Investigations (OCI), or the FBI scrutinizes a life sciences organization or its leadership, the consequences are existential. At risk are your personal liberty, DEA scheduling privileges, FDA facility registrations, and your professional legacy.
Lowther | Walker delivers elite, nationwide FDA white-collar defense. We recognize that federal authorities frequently weaponize regulatory ambiguity — transforming good-faith compliance decisions, evolving CGMP interpretations, and complex scientific disagreements into criminal indictments. You require counsel possessing absolute fluency in federal criminal litigation, the FDCA, the Anti-Kickback Statute, and the DQSA.
Lowther | Walker’s attorneys bring over 20 years of defending clients in DEA investigations to your case. A prime example of our experience is in US v. F.R.
The DEA and IRS-CI searched our medical-doctor client’s pain clinic and residence for evidence of his overprescribing controlled substances to his patients and evading business and personal income taxes. The agents seized approximately $1.2 million in cash from his residence and approximately $1.8 million from his various bank accounts. We convinced the DOJ not to prosecute him for the drug offenses, for which he faced 97–121 months in prison. We also convinced the DOJ to dismiss the civil asset-forfeiture case against him, recovering the full $3 million (with interest) that the agents seized.
Assessing criminal exposure demands mastery of 21 U.S.C. § 331, the strict-liability framework of the Park doctrine, FDA CGMP Guidance, the DQSA, the BPCIA, and the 2023 FDASLA amendments. We navigate these frameworks daily.
We understand exactly how a routine Form 483 observation escalates into a criminal referral — and how to intercept it.
We systematically dismantle government assertions of “adulteration” or “misbranding” using the FDA’s own precedents and guidance documents.
We collaborate with top-tier forensic compliance experts and pharmaceutical scientists to neutralize the government’s procedural and molecular theories.
FDA criminal prosecution is exclusively a federal domain, allowing our specialized counsel to represent clients nationwide. Whether your operations are based in California, Texas, Ohio, or New Jersey, and whether the investigation originates in the District of Massachusetts (a historical epicenter for pharmaceutical prosecutions) or the Eastern District of New York, Lowther | Walker brings uncompromising defense to any U.S. federal district court.
Lowther | Walker’s defense services include the following areas:
The FDA’s Office of Criminal Investigations (OCI) actively investigates breaches in the medical supply chain, which includes the diversion of prescription medications for illicit uses or dispensing them without a valid prescription.
This is a broad category that inherently includes FDA defense. FDA fraud investigations target a wide range of illegal activities, such as manufacturing counterfeit drugs, making unsubstantiated claims about medical devices, and falsifying clinical trial data.
Medicare Fraud and Medicaid Fraud
These financial crimes frequently stem from underlying FDA violations. If a provider administers an unapproved, misbranded, or counterfeit drug (an FDA violation) and subsequently bills a federal health program like Medicare or Medicaid for that treatment, the case will likely be prosecuted under the Healthcare Fraud Statute or the False Claims Act.
Audits act as a primary discovery mechanism for FDA violations. A routine healthcare audit of a pharmacy or medical practice’s supply chain documentation can uncover the purchase of unapproved medications from unknown sources, which can quickly escalate into a full FDA investigation.
The FDCA strictly prohibits introducing a “misbranded” drug or medical device into interstate commerce. A product is considered misbranded if its labeling is false or misleading, if it lacks adequate directions for use, or if it is marketed for an unapproved use.
In the healthcare sector, providers and corporate executives are frequently charged with misbranding when they actively promote a drug or device for “off-label” applications or make false representations regarding a medication’s safety profile.
Adulteration charges apply when a drug or medical device is manufactured, processed, or held in substandard conditions, or when its strength, purity, or quality falls below established standards.
Providers or manufacturers can face criminal charges for shipping, distributing, or administering adulterated products—such as medications that have been illegally repackaged, compromised, or contaminated—even if only a single order is involved.
While the FDA regulates the safety and marketing of medical products, violations often trigger massive civil liability under the False Claims Act. Providers and companies face FCA charges for knowingly submitting (or causing others to submit) fraudulent claims to government healthcare programs like Medicare and Medicaid.
In FDA-related fraud, this commonly manifests as billing for medically unnecessary services, “upcoding” (billing for a more expensive procedure than performed), or submitting claims for treatments involving unapproved or fraudulently marketed medical devices.
Under the Park doctrine, healthcare executives and corporate officers can be held strictly liable for FDCA violations (such as misbranding or adulteration) committed by their companies. Prosecutors do not have to prove that the executive had direct knowledge of the fraud, intended to commit a crime, or was even personally involved. A conviction only requires proving that the executive held a position of authority and failed to prevent or promptly correct the violation. This is typically a misdemeanor, but it can be elevated to a felony if there is evidence of an intent to defraud.
Because fraudulent medical schemes almost always involve electronic billing systems, the postal service, or interstate communications, prosecutors in DEA cases frequently add mail and wire fraud charges. These are broad federal statutes used to prosecute individuals who devise a scheme to defraud patients or insurers by using the mail or wire communications to execute fraudulent marketing or distribution of FDA-regulated products.
When your DEA registration and medical practice are in the federal government’s crosshairs, you cannot afford a wait-and-see approach. At Lowther | Walker, we do not sit back and wait for an indictment to dictate your future. We go on the offensive.
Our legal team executes aggressive, pre-indictment interventions designed to stop federal investigations in their tracks. We recognize the intense scrutiny healthcare providers face, and we meet the government’s resources with our own. By deploying a specialized network of former federal special agents, we conduct rigorous, independent investigations to uncover crucial exculpatory evidence and dismantle the prosecution’s narrative before their case can even take shape.
Contact Lowther | Walker today to protect your practice, your license, and your future.
When the DEA’s Office of Diversion Control or the DOJ targets your prescribing practices or distribution metrics, they are not just auditing paperwork. In parallel, they are building a case to revoke your DEA registration, seize your assets, and pursue criminal indictments under the Controlled Substances Act. Waiting for a formal grand jury subpoena or an administrative shutdown may cost you your career and your liberty.
Call Lowther | Walker immediately at (404) 806-7997 to speak with an experienced FDA defense lawyer.
No-obligation. Fully confidential.
Call Us Today: (404) 496-4052
A DEA Order to Show Cause (OTSC) is issued when the DEA’s Office of Diversion Control alleges your registration is inconsistent with the public interest under 21 U.S.C. § 824. You must request an administrative hearing before an Administrative Law Judge (ALJ) within 30 days to prevent immediate revocation.
Under the Park doctrine (United States v. Park, 421 U.S. 658), the FDA can hold “responsible corporate officers” strictly liable for misdemeanor violations of the Food, Drug, and Cosmetic Act under 21 U.S.C. § 331, such as CGMP deviations, even without actual knowledge or criminal intent.
Do not answer their questions. You are not required to speak to them without an attorney present, even if they claim they “just want to clear a few things up.” Ask for their business cards, politely state that your attorney will contact them, and ask them to leave. Then, call Lowther | Walker immediately. Anything you say during that initial surprise visit can be used to build the indictment against you.
Under the Controlled Substances Act and DEA regulations (21 C.F.R. § 1301.74(b)), distributors must design an SOM system to identify and halt orders of unusual size, frequency, or pattern. Failing to report and halt these red flag orders can lead to DEA registration suspension and civil penalties.
An FDA Form 483 inspection escalates to an OCI criminal investigation if inspectors find evidence of intentional fraud, data manipulation (violating 18 U.S.C. § 1001), or failure to remediate severe adulteration issues (21 U.S.C. § 351). OCI will then investigate the facility for criminal prosecution by the DOJ.
An Immediate Suspension Order (ISO) issued under 21 U.S.C. § 824(d) immediately strips your authority to prescribe or dispense Schedule II-V controlled substances. You must immediately cease operations involving controlled substances while aggressively contesting the ISO in federal court or before a DEA ALJ.
Off-label promotion occurs when a manufacturer markets an FDA-approved drug or device for an unapproved indication. The DOJ prosecutes this under 21 U.S.C. § 331 as the introduction of a “misbranded” product into interstate commerce, though First Amendment protections for truthful scientific exchange provide a critical defense.
The Anti-Kickback Statute (42 U.S.C. § 1320a-7b) criminalizes offering or receiving remuneration to induce referrals for federal healthcare programs. In FDA/DEA cases, the DOJ often alleges that sham speaker fees, prescribing incentives, or consulting agreements were used to boost sales of controlled substances or misbranded drugs.
No. DEA administrative hearings are governed by the Administrative Procedure Act (APA), not the Federal Rules of Evidence or Criminal Procedure. They are heard by a DEA Administrative Law Judge (ALJ), rely heavily on documentary evidence, and lack a jury, demanding highly specialized regulatory defense strategies.
Surrendering your DEA registration (using DEA Form 104) does not immunize you from criminal prosecution under the Controlled Substances Act. The DOJ and DEA’s Office of Diversion Control can still pursue federal indictments, civil fines, and collateral consequences even after you voluntarily relinquish your prescribing authority.
