FDA Investigation

FDA Investigation Lawyers in Houston

Counsel for FDA Enforcement & Fraud Investigations

The U.S. Food and Drug Administration has become increasingly active in rooting out waste, fraud, and abuse. In addition to issuing warning letters, requiring immediate corrective action, and issuing record requests, the agency has also ramped up its investigations of health care fraud and enforcement actions.

The FDA’s law enforcement branch, the FDA Office of Criminal Investigations (OCI), was established to conduct and coordinate investigations into more serious FDA fraud allegations, including violations of the Federal Food, Drug, and Cosmetic Act (FDCA).

OCI investigations are not routine matters. Instead, they arise in cases of significant regulatory violations and non-compliance, and create significant exposure for prosecution before the Department of Justice.

The OCI prioritizes investigations involving:

  1. False statements made to the FDA during regulatory matters.
  2. Unapproved, counterfeit, and substandard medical products.
  3. Cases where standard regulatory compliance processes have failed to correct violations and / or where violations present dangers to the public.

If you are a provider, pharmacist, supplier, clinical laboratory, or medical business that has been alerted to an investigation involving the FDA, taking immediate action to intervene and explore your options for a defense and resolution is vital.

Proven Health Care Counsel & Fraud Defense

Hendershot Cowart P.C leverages decades of experience counseling health care clients in high-stakes proceedings to defend against civil and administrative FDA enforcement actions and investigations.

We provide immediate representation to mitigate risks for criminal liability and penalties, and work proactively to address existing compliance concerns and limit exposure to future enforcement action.

FDA investigations can create considerable disruption for your practice or pharmaceutical business and put serious penalties or prison time on the table. Because these are time-sensitive matters, we encourage health care clients to speak with a lawyer as soon as possible. Call or contact us online to request a confidential consultation.

What Do FDA Investigations Target?

The FDA has broad oversight over matters involving prescription drugs, medical devices, and other FDA-regulated products. Their investigations may concern violations and alleged fraud involving a range of issues, including:

In addition to various regulatory violations, the FDA and its OCI division actively target health care providers and businesses implicated in fraudulent schemes. This includes schemes involving:

  • Products which claim to prevent, treat, or cure diseases or health conditions, but have not been substantiated in safety or efficacy.
  • Ineffective or potentially dangerous cures for cancer, AIDS, and Alzheimer’s.
  • The unlawful offering, solicitation, payment, or receipt of kickbacks, referral fees, or rebates.
  • Fraudulent schemes to secure FDA approval.
  • Billing of Medicare, TRICARE, VA, and other federal health program beneficiaries for unapproved drugs or devices.

Providers who fall into the FDA’s crosshairs face significant exposure to civil penalties, inter-agency referrals, and criminal prosecution. Those risks increase exponentially when providers fail to correctly or sufficiently comply with initial FDA probes and administrative inquiries and the OCI steps in.

Though the stakes are high in health care fraud investigations, a carefully calculated response initiated early in enforcement proceedings can help tender reasonable resolutions that shield providers from criminal prosecution and the most devastating penalties.

Comprehensive Counsel & Defense for FDA Enforcement Actions

Hendershot Cowart P.C. delivers experienced counsel and custom-tailored defense strategies for even the most complex and high-stakes cases.

Our health law attorneys provide both proactive and responsive health care counsel, and we offer a comprehensive approach to structuring strategies that keep cases within the civil realm.

Our services include:

  • Responding to FDA warning letters, audits, enforcement actions, and investigations.
  • Opening lines of communication with regulators to ease practice / business disruptions.
  • Facilitating demands for document production, record requests, and interviews to limit the scope of inquiries and minimize time and cost consumption.
  • Negotiating resolutions on reasonable terms with an emphasis on corrective compliance actions and avoidance of criminal referrals and prosecution.
  • Proactive compliance audits and counsel for medical start-ups, joint ventures, telemedicine, and other transactions / contractual relationships.
  • Counsel for other regulatory and administrative actions, including medical license defense, state regulatory investigations, Medicare audits, and more.

Speak with an FDA Investigation Attorney Today. Call (713) 909-7323

Hendershot Cowart P.C. is comprised of award-winning attorneys who draw from over a century of collective experience to aid health care clients in matters of compliance and alleged fraud involving the FDA and other state and federal regulators.


If you wish to discuss an FDA investigation or other regulatory health care matter, call (713) 909-7323 or complete an online contact form.

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