- The Food and Drug Administration (“FDA”) is the federal agency that is responsible for protecting public health by assuring the safety of products, drugs, food supply, and other products that may harm the public.
- The FDA has the authority to conduct civil investigations as well as criminal enforcement proceedings against individuals and companies suspected of violating its provisions. It routinely refers matters to the DOJ for criminal prosecution.
- One of the tools the FDA utilizes to assist in its investigations is the subpoena power.
- A subpoena is a court order that commands a witness to appear at a certain time and place to give testimony on a specified subject matter relevant to the FDA’s investigation or to produce documents and certain records—a subpoena duces tecum.
- Title 21 of the Code of Federal Regulations is reserved for rules of the FDA, including packaging, manufacturing, design, labelling, and the monitoring of medical devices. It also governs the process for subpoenas for FDA employees and officials as well as administrative inspections.
- The subpoena process can be a worrisome time, especially because the failure to comply may result in obstruction of justice and contempt charges.
- Consider hiring a team of FDA defense attorneys to assist you in proceeding with an FDA subpoena or other subpoena relating to the FDA.
Experienced FDA Defense Team
If you have received a subpoena from the FDA, it is critical that you get in touch with an FDA defense attorney today.
While a subpoena could merely indicate that the FDA is using you as a witness as a part of a larger investigation into another target, it is also possible that the FDA is investigating your company’s operations. Further, anything that is revealed from your testimony could lead to more challenges along the road.
At Oberheiden, P.C., our team of FDA defense attorneys intricately understand the subpoena process and how the FDA operates. We carefully guide our clients through and passed an FDA subpoena as well as any secret attempts to scrutinize you and your company.
Our attorneys include former FBI agents, former U.S. attorneys, and former prosecutors. This interdisciplinary approach gives our clients the best chance of success throughout the FDA’s investigative process.
Do not wait to get in touch with a qualified FDA defense attorney today. Put Oberheiden, P.C. on your side to fight for your freedom and reputation.
What is the FDA?
The Food and Drug Administration (“FDA”) is the federal agency that is charged with the responsibility of protecting the public health by assuring the safety and security of products, drugs, medical devices, the nation’s food supply, and other products that may present a danger to society.
It can conduct civil investigations into individuals and companies suspected of violating its provisions, thereby endangering the public health.
It can also bring criminal enforcement proceedings to investigate illegal conduct involving FDA-regulated products. These matters are often referred to the DOJ for prosecution.
What is an FDA Subpoena?
A subpoena, broadly, is a court order that commands a witness to appear at a certain time and at a certain place to provide testimony on a certain subject matter.
It can refer to either verbal or written testimony. A request for verbal testimony simply refers to a request for the witness to appear and answer questions orally. Written testimony is testimony documented such as the use of an affidavit.
A subpoena might also include a request for the witness to produce documents or certain records. In such cases, the subpoena is called a subpoena duces tecum, which refers to a court order that commands the witness to produce documents or certain records at a certain time and at a certain place. The FDA possess the power to process these records under sections 20.1 and 20.2 of Title 21 of the Code of Federal Regulations (“CFR”).
Code of Federal Regulations – Title 21 – Food and Drugs
The Code of Federal Regulations (“CFR”) is a codification of the general and permanent rules by executive departments and agencies of the federal government.
Title 21 is reserved for rules of the FDA. It governs several aspects under the purview of the FDA such as clinical evaluation, packaging, manufacturing, design, labelling, and post-market monitoring of medical devices. The regulations in Title 21 also address product reports and other regulatory standards.
FDA Employees: 21 CFR § 20.1 and § 20.2
These two sections govern testimony and the production of records by FDA employees.
Testimony by FDA Employees
Regarding testimony, no officer or employee of the FDA, with certain exceptions, shall give any testimony before any tribunal that pertains to any function of the FDA or with respect to information that was acquired in the discharge of that individual’s official duties.
When that FDA officer or employee has been served with a subpoena, he or she must, with certain exceptions, respectfully decline to testify. An individual may make a written request to the Commissioner explaining why they want the desired testimony and what the use of such testimony would be.
If such request is granted, an employee or employees of the FDA will appear and testify.
Production of Records by FDA Employees
When a subpoena duces tecum has been served on an officer or employee of the FDA that commands the production of any record, the officer of employee shall respectfully decline to produce the record. These requests are handled instead by the rules governing public disclosure.
As an additional point of reference, 21 CFR § 20.3 governs the certification and authentication of FDA records, including subpoenas, and typically requires the FDA to certify as to the authenticity of an FDA record.
Administrative Inspections: 21 CFR 1316.07
For all food and drug inspections, an administrative inspection warrant is required. There are exceptions to this warrant requirement for companies applying for initial registration, for the inspection of books and records pursuant to an administrative subpoena under U.S. Code § 876, and for entries in administrative inspections under the following conditions:
- with the consent of the owner or individual in charge of the premises;
- in situations that present an imminent danger to health or safety;
- inspections where there is reasonable cause to obtain a warrant
- in any other exceptional or emergency circumstances or opportunity to apply for warrant is lacking; or
- any other situations where a warrant is not constitutionally required.
Subpoenas: 21 U.S. Code § 876
The U.S. Code authorizes the Attorney General to subpoena witnesses and to require the production of documents or any records—including books, papers, and other tangible items—that the Attorney General finds relevant or material to the investigation.
If an individual refuses to obey the subpoena, the Attorney General may invoke the assistance of any court with jurisdiction in order to compel compliance with the terms of the subpoena.
The court may then issue an order compelling the subpoenaed person to appear to give testimony or produce records. If the individual fails to comply, he or she will be punished by the court with contempt charges.
What to Do If You Receive an FDA Subpoena
The most important thing to do when you or your company has received an FDA subpoena is to always provide truthful information and never to lie. Good practices include providing truthful information in response to FDA questions and meeting all deadlines.
Many companies choose to have a system developed that designates an individual that will take the lead role in assisting the FDA in carrying out the terms of the subpoena or in responding to FDA-initiated investigations.
Although FDA subpoenas as well as FDA investigations can make most people anxious, you should always try to stay calm. Never ignore a subpoena. Obstruction of justice is a criminal offense. Providing false information to the FDA is also a criminal offense.
However, it is possible to fight a subpoena. If an individual believes the subpoena is unreasonable, oppressive, excessive in scope, or otherwise unduly burdensome, that individual may file a motion to quash the subpoena stating the basis for such a request.
The process is very intricate and is riddled with procedural complexities. It requires the assistance of an attorney specialized in the subpoena process and in dealing with regulatory authorities.
At Oberheiden, P.C., our FDA defense attorneys surpass these qualifications. Give us a call today.
Need Advice with FDA Subpoenas?
Being served with a subpoena can definitely cause apprehension and anxiety no matter the circumstances of what the subpoena entails. Sometimes, the worst part is that companies are not aware that a potential investigation into their companies’ practices may be underway.
It is important to remember to always be truthful when responding to an FDA subpoena because lying is a criminal offense and can be accompanied with severe penalties and jail time as well as contempt of court.
The best strategy to pursue is to hire an FDA defense attorney that can guide you through the subpoena process, what is expected of you, how you can comply in the most efficient manner, and when to contest certain actions.
The defense attorneys at Oberheiden, P.C. have the experience and knowledge needed to respond to an FDA subpoena, including a request for documents.
If you have received an FDA subpoena and are worried about the next steps, call 888-680-1745 or contact our office for a free consultation.