FDA Subpoena? Here’s What You Need to do Next to Protect Your Company

Experienced FDA Defense Team

Have you received a subpoena from the FDA? Are you concerned about the multiple document requests and/or demands for testimony? If so, then do not hesitate to get in touch with an experienced FDA defense attorney.

A subpoena is basically a demand to produce documents and/or provide testimony relating to a particular subject matter.

It may indicate that the FDA is seeking such information from you as a witness in connection with a larger investigation. Alternatively, it can be equally possible that the FDA is considering whether to open an investigation directly into your business’ operations.

Because of the uncertainty at this early stage, it is critical that you retain the legal services of a defense attorney as soon as possible.

At Oberheiden, P.C., our team of FDA defense attorneys has a comprehensive degree of knowledge and experience in navigating the subpoena process as well as negotiating with the FDA.

Do not make the mistake of believing that these requests from the FDA will go away. Failure to comply with the deadlines set forth in the subpoena could lead to serious criminal charges such as contempt and obstruction of justice.

We can defend you and your company against a federal subpoena from the FDA. Do not wait to get in touch with an FDA defense attorney today.

Put Oberheiden, P.C. on your side to fight for your freedom and reputation and defend your business.

Put our highly experienced team on your side

Dr. Nick Oberheiden
Dr. Nick Oberheiden

Founder

Attorney-at-Law

John W. Sellers
John W. Sellers

Former Senior Trial Attorney
U.S. Department of Justice

Local Counsel

Joanne Fine DeLena
Joanne Fine DeLena

Former Assistant U.S. Attorney

Local Counsel

Joe Brown
Joe Brown

Former U.S. Attorney & Former District Attorney

Local Trial & Defense Counsel

Amanda Marshall
Amanda Marshall

Former U.S. Attorney

Local Counsel

Aaron L. Wiley
Aaron L. Wiley

Former Federal Prosecutor

Local Counsel

Roger Bach
Roger Bach

Former Special Agent (OIG)

Michael Koslow
Michael Koslow

Former Supervisory Special Agent (FBI)

Chris Quick
Chris Quick

Former Special Agent (FBI & IRS-CI)

Kevin M. Sheridan
Kevin M. Sheridan

Former Special Agent (FBI)

Ray Yuen
Ray Yuen

Former Supervisory Special Agent (FBI)

Dennis A. Wichern
Dennis A. Wichern

Former Special Agent-in-Charge (DEA)

What Is the FDA and What Does It Investigate?

The Food and Drug Administration (“FDA”) is a federal agency that protects society from dangerous and misleading products, drugs, medical devices, food, and other products that may harm society. The FDA’s mission is to ensure the safety and security of these products.

To carry out is mission, it is empowered to conduct civil and criminal investigations. The FDA’s civil investigations analyze individuals and companies who are allegedly violating some FDA provision by endangering or misleading society.

The FDA can also bring criminal investigations against individuals and companies for engaging in illegal conduct involving FDA-regulated products. These investigations are often referred to the Department of Justice (“DOJ”) for further criminal prosecution.

The agency is empowered to investigate many products including food, the food supply, prescription drugs, medical devices, supplements, tobacco, labelling & advertising, imports, the manufacturing and supply chain process, etc.

There are many departments and offices within the FDA which have different responsibilities and focuses. For instance, the FDA’s Office of Prescription Drug Promotion (“OPDP”) regulates the drug promotion of companies and undertakes enforcement measures for violations.

Additionally, the FDA’s Office of Criminal Investigations (“OCI”) coordinates and investigates criminal investigations into products that pose a danger to the public health.

The FDA’s Subpoena Power

A subpoena is defined as a court order that demands the recipient to provide certain requested documents and/or provide testimony in connection with a particular subject matter.

Document production can refer to information that is either in physical or electronic form. It could authorize the recipient to produce records, books, papers, and other items.

Testimony requests can refer to either written or verbal testimony. Verbal testimony means a request for the recipient to appear at a certain time and at a place time and answer questions. On the other hand, written testimony means testimony that is documented (e.g., affidavit).

If the recipient fails to comply with the terms of the subpoena and its deadlines, the individual may face contempt charges.

Next Steps After Receiving an FDA Subpoena

Receiving a subpoena from the FDA can be a stressful and worrisome time. The subpoena may be requesting mounds of documentation and records over a span of many years. It may also be requesting that you appear and provide testimony.

However, there are steps that you can take immediately to start protecting your company. Below we provide a list and brief description of these steps:

  • Hire an attorney experienced in FDA investigations and the subpoena process. It is always best to retain a team of attorneys who are experienced in handling complex FDA investigations as well as dealing with FDA negotiations. An attorney can help you determine which documents are privileged, how to submit your materials, how to prepare for testimony, and how to navigate the entire federal subpoena process. In some cases, your attorney will be able to request a deadline extension of your document requests and testimony. In other cases, your attorney can challenge the subpoena by filing a motion to quash if your attorney believes that the requests are too unreasonable, excessive, or otherwise burdensome.
  • Start accumulating and gathering the requested documents. The subpoena will typically describe in detail the materials, documents, and records to be produced by a certain deadline. Start gathering these materials for your attorney to review. Getting a head start on document production will allow your attorney to move immediately to the review stage and then concentrate on preparing your defense.
  • Always be truthful and never act dishonestly with federal agencies. If the agency or a judge discovers that you have been dishonest, provided false documentation, or even destroyed evidence, your case will be horribly affected. You may even face criminal charges such as obstruction of justice. Always tell the truth. Providing truthful and complete information will reflect you and your company in a positive light when the FDA evaluates all requested documents and testimony.
  • Understand that some documents and records may be privileged. If the FDA is requesting material in connection with an investigation, it is important to understand your constitutional rights. For instance, certain information is protected by the attorney-client privilege and cannot, therefore, be compelled by the subpoena. Also, if certain documents or testimony would incriminate you, do not forget that you have the right to claim your Fifth Amendment right against self-incrimination. These and other rights can be confusing, which is why it is imperative to retain an FDA defense attorney as soon as possible.
  • Never ignore the requests in the subpoena. Many individuals believe that some requests can be simply be ignored or will be overlooked, especially if the FDA receives plenty of other documents and records. This is far from the truth. Deliberately ignoring a request in the subpoena could lead to obstruction of justice and contempt charges—which are criminal offenses.
  • Ask questions to your attorney. Your attorney is your advocate and is on your side to defend you. Always ask questions where you are unsure as to the investigative or subpoena process or need clarification on document production or testimony. Your attorney can help you with various matters regarding your subpoena such as filing for deadline extensions, preparing for testimony, accumulating documents for submission to the agency, determining which documents are privileged, communicating with the FDA on your behalf, etc. Do not be afraid to ask questions. Your attorney can provide you with clarity and peace of mind.
  1. Stay calm and show respect. Remember to always stay calm and be respectful with your attorney and the FDA staff. The FDA and judges do not take kindly to rude or accusative behavior. Maintain an attitude of open communication and cooperation. This is important because federal agencies often take cooperation by the company into account when deciding to initiate an investigation or when determining sanctions.

The subpoena process is very complex and contains many exceptions and subjectivity.

Its successful navigation requires the assistance of an attorney who is experienced in FDA investigations and the federal subpoena process.

If you have any questions regarding this process, do not wait any longer to contact Oberheiden, P.C. right away.

Need Assistance on How to Respond to an FDA Subpoena?

The subpoena process can easily make individuals feel uneasy, especially where the subpoena demands countless documents and testimony.

The hardest part is often that individuals are unable to ascertain their role in the investigation: are they the target or merely a witness?

This is why it is so important to always remember to protect yourself at all times and as soon as possible. Retaining an attorney experienced in FDA investigations and negotiations is your best defense.

At Oberheiden, P.C., our FDA defense attorneys are highly experienced in handling the FDA subpoena process. Our attorneys come from prominent government positions such as former federal prosecutors and former FBI agents as well as from the private sector.

We are poised to provide you with the best defense to protect you and your company. Let us help you.

If you have received an FDA subpoena and need legal advice, call or contact our office for a free consultation to protect your business and reputation.

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