Knowledge base

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.

How to Report FDA Fraud

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

  1. Gather all relevant documentation that you are lawfully entitled to as part of your job duties. Such documentation 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)
  1. 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. For example:

(1) Describe any FDA-approval misrepresentations or CGMP material violations;

(2) Describe any misrepresentations made to physicians or the FDA, about the product, to include misrepresentations about safety, efficacy, and/or manufacturing processes.

(3)  Explain off-label uses targeted, if any. Explain the percentage of estimated off-label sales of each product and a breakdown of the off-label use percentage. Explain types of physicians targeted for off-label use; what reports and target lists reps were provided with, etc.

D. Kickbacks

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

(2) Describe any and all of the following payments made for or to physicians:

– Honorariums

– Grants

– Preceptorships

– Advisory Board Meetings (“Round Tables”)

– Other consultant positions.

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

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.

E)  Manufacturing Violations

(1) 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.

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

F)  Pharmaceutical Pricing Violations

(1) Describe misrepresentations of any price reporting to the Center for Medicareand Medicaid Services (CMS).

(2) 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 & White 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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OUR PROMISE When it feels like you are facing insurmountable odds, we will be there for you!

We know the struggles whistleblowers face before contacting us, and know that deciding to be a whistleblower can be difficult. We will be with you every step of the way, strong and proud, helping you stand up for what is right.

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