How to Report FDA Fraud

Contact Form - Your First Step

Companies in FDA-regulated industries continue to engage in fraud. From pharmaceutical fraud and biotech fraud, to medical device fraud and medical equipment fraud, the landscape has broadened. One reason may be a lack of sufficient resources for the FDA to regulate and fully police these industries. To report FDA fraud, either instead of, or in conjunction with filing a qui tam lawsuit, the most relevant governmental agency to contact is the FDA’s Office of Criminal Investigations (FDA-OCI), located in Rockville, Maryland.

Should you choose to contact us to report FDA fraud, we suggest taking the following steps:

  1. Document. Gather all relevant documentation which you are otherwise entitled to receive as part of your job duties. This includes Marketing Plans, PowerPoint presentations or binders from Plans of Action or annual meetings, emails, memos, call notes, etc. (Do not photocopy, download, or take any documentation that you are not entitled to view, or is in violation of policy or procedure);
  2. Write a short summary of the fraud. This is important as the facts are fresh in your mind now, as opposed to years from now. You need to do this whether or not you file a whistleblower lawsuit. We suggest that you provide the following information in your summary:

A.   Describe the organization of the company. Explain divisions, hierarchy, management names, etc. Which divisions were involved? What were their responsibilities?

B.   List and describe the Management Players.

C.   Summarize the fraud in detail (four common areas are listed below):

1) Off-Label Marketing

i.   Describe sales training. Include the time period and all details about any off-label aspect of it, both initial and thereafter. Also include medical liaisons and reimbursement specialists, if applicable, and any others who were part of the sales force.

ii.  Describe sales meeting details.

iii.  Describe compensation details.

iv.  Explain off-label uses targeted.

v.  Explain the percentage of estimated off-label sales of each product and a breakdown of the off-label use percentage.

vi. Explain types of physicians targeted for off-label use; what reports and target lists reps were provided with, etc.

vii.  Describe the techniques used to interact with physicians.

viii.  Describe any misrepresentations made to physicians.

2) Kickbacks

i.  Describe any speaker programs, clinical trials, registries, and other “clinical” programs handled by marketing or sales; and attendee benefits (include discussion of speaker training, of speaker presentations, and whether they kept to script, attendee selection, etc.).

ii.  Describe any and all of the following payments made for or to physicians:

– Honorariums;

– Grants;

– Preceptorships;

– Advisory Board Meetings (“Round Tables”); and

– Other consultant positions.

iii.  Describe any inappropriate payments made to equipment distributors, hospital systems, specialty pharmacies, any Pharmacy Benefit Manager fraud, or any other fraud involving third parties.

iv.  Make a list of all documents that are not in your possession but that you believe are relevant. Doing so now will also be helpful to you to crystallize the facts, whether or not you file a qui tam lawsuit.

3)  Manufacturing Violations

i.  Describe any material unreliability issues, known quality control failures, finished product release specification issues (i.e. describe how the devices were manufactured with performance characteristics that were set below what was claimed as performance specifications in respective product inserts, PMA’s and 510(k) submissions, which has resulted or could result in substandard, defective products). Describe other problems that the manufacturer is or should be aware of but has not adequately fixed or warned the provider community.

ii. Make a list of all documents that may or may not be in your possession but that you believe are relevant.

4)  Pharmaceutical Pricing Violations (Pharma Companies Only)

i. Describe misrepresentations of any price reporting to the Center for Medicare and Medicaid Services (CMS).

ii. Make a list of all documents that may or may not be in your possession but that you believe are relevant.

If we accept your case for investigation, Nolan Auerbach, will engage in a thorough and confidential evaluation of the facts. We will assess whether the law and regulations, together with the evidence, support allegations of widespread healthcare fraud. We will then provide you with feedback on your potential case, and jointly discuss whether to proceed.

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