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FDA Subpoena

Understanding FDA Subpoenas: A Legal Guide

Receiving a subpoena from the U.S. Food and Drug Administration (FDA) can be an intimidating and stressful experience. As the regulatory body responsible for protecting public health by overseeing food, drugs, medical devices, cosmetics and more, the FDA has broad authority to investigate violations of federal laws and regulations.If you or your company is the recipient of an FDA subpoena, it’s important to understand what it means and how to respond appropriately. This guide covers the key things you need to know.

What is an FDA Subpoena?

An FDA subpoena is a written demand for documents, tangible things, or testimony related to an FDA investigation. It requires the recipient to provide the specified materials or appear and answer questions.Subpoenas are used by the FDA’s Office of Criminal Investigations and Office of Regulatory Affairs to gather evidence during investigations into regulated products or entities. These may include investigations into:

• Food, drug, medical device or other product safety issues
• False or misleading labeling claims
• Manufacturing problems
• Data integrity concerns
• Consumer complaints or injuries
• Suspected criminal violations of FDA regulations

Failure to comply with an FDA subpoena can result in legal penalties including fines or jail time. So it is essential to take these demands seriously.

Who Can Receive an FDA Subpoena?

FDA subpoenas are often sent to:

• Manufacturers and distributors of FDA-regulated products
• Testing laboratories contracted to analyze products, ingredients, environments, etc.
• Healthcare facilities that use medical devices
• Pharmacies and prescription drug wholesalers
• Physicians and other healthcare providers
• Consultants, attorneys, or other third parties involved with regulated firms

Essentially anyone that possesses materials relevant to an FDA investigation could receive a subpoena demanding those materials.

What Should You Do if You Receive an FDA Subpoena?

If your organization is issued an FDA subpoena, you should:

1. Notify management – Make sure appropriate executives and legal counsel are informed of the subpoena’s receipt.
2. Do NOT destroy any relevant materials – Document retention and destruction policies should be halted in relation to anything covered by or relevant to the subpoena.
3. Assemble a response team – Identify key individuals in legal, regulatory, IT, records management, and relevant operations to coordinate your response.
4. Review the subpoena carefully – Determine exactly what information and materials are being requested, as well as any instructions and specifications provided. Note all required deadlines.
5. Determine if you will comply – In rare cases, grounds may exist to contest or file a petition to limit the subpoena. Consult FDA enforcement attorneys to advise.
6. Begin gathering responsive materials – Use written litigation hold notices and coordinate with IT to search electronic systems. Be thorough in collecting data sources listed in the subpoena.
7. Consult an attorney – Have counsel review accuracy and completeness of your response. They can also advise on formats, production procedures, and negotiating extensions if needed.

Attempting to avoid or obstruct an FDA subpoena can lead to significant penalties. It’s important to engage legal guidance early in the process.

What Kinds of Materials Might be Subpoenaed?

The types of information and documentation requested by an FDA subpoena will vary depending on the nature of the investigation. But some examples may include:

• Manufacturing records – Master production schedules, batch records, equipment cleaning logs, calibration and maintenance records, temperature charts, etc.
• Testing data – Laboratory notebooks, test reports, raw data, validation and verification studies, stability testing, certificates of analysis, etc.
• Employee training records – Standard operating procedures, training manuals/materials, attendance logs, exam and quiz results, etc.
• Communications – Emails, letters, meeting minutes, notes, phone logs related to development, manufacturing, testing, marketing, or safety of regulated products.
• Consumer complaints – Records related to adverse events, injuries, product quality issues, etc. reported about a company’s products.
• Previous FDA communications – Any prior warning letters, untitled letters, 483 inspection reports, etc. from FDA interactions.

Essentially any document related to activities and products under FDA’s jurisdiction could potentially be requested.

How Should You Produce Records to the FDA?

When producing materials in response to an FDA subpoena, proper formats and organization is vital. The agency provides specific guidelines to ensure efficient review:

• Electronic records should be provided in native formats on CD, DVD, or hard drives whenever possible. Include descriptive filenames and folders.
• Paper documents should be Bates stamped sequentially and produced in sturdy boxes properly labeled with descriptions.
• Provide metadata and audit trails showing chain of custody and record modification details.
• Organize files in labeled folders by category, date, record type, etc. to enable easy access to materials.
• Provide index and description to explain what is included and outline the file structure. Note any missing records.
• Use appropriate redactions to protect private personnel records or trade secrets and mark accordingly.

Following FDA standards for information presentation is mandatory when responding to a subpoena. This helps facilitate the investigation and prevent the need for supplemental requests.

What Happens After Producing Records?

After fulfilling an FDA subpoena by producing requested materials, a few next steps may occur:

• Supplemental requests – If its investigation reveals gaps, the FDA may issue additional subpoenas requesting more records.
• Employee interviews – FDA agents may ask to interview personnel with knowledge related to the materials produced.
• Inspections – The FDA may schedule an onsite inspection to tour facilities, review operations, or confirm accuracy of records.
• Continued monitoring – The FDA may continue to monitor company operations, review records, and require periodic reports.
• Enforcement actions – If violations are found, the FDA may issue warning letters, initiate seizures, impose fines, or pursue criminal charges.

Complying with an FDA subpoena is not necessarily the end. It often signals enhanced scrutiny and long-term oversight by the agency. Continued cooperation is wise to avoid stiffer penalties.

Working with Experienced Counsel

Receiving an FDA subpoena can be unsettling, but making missteps in your response could have significant legal and financial consequences. Engaging experienced legal counsel is highly recommended when dealing with these regulatory demands.Skilled FDA attorneys can help by:

• Advising on response strategy – They can manage communication and negotiations with FDA officials related to the subpoena.
• Overseeing information gathering – They ensure thoroughness and accuracy in collecting responsive records.
• Reviewing material completeness – They can identify potential gaps or inadequacies in a production response.
• Preparing written responses – They help craft required affidavits confirming record searches performed and materials provided.
• Presenting records properly – They ensure technical formatting protocols are met for submission to the FDA.
• Attending interviews – They represent and advise clients called in for questioning by FDA agents.

By leveraging knowledgeable legal counsel, companies can improve compliance, demonstrate cooperation, and mitigate fallout from FDA subpoenas. Treading carefully is crucial.

References

U.S. Food and Drug Administration. (2022). Regulatory Procedures Manual Chapter 4: Advisory Actions. https://www.fda.gov/media/71878/downloadAxendia Inc. (2019). Responding to FDA Form 483 and Warning Letter Observations. https://www.axendia.com/responding-fda-form-483-warning-letter-observationsEisner, A. (2021). A Basic Primer on FDA Subpoenas. JD Supra. https://www.jdsupra.com/legalnews/a-basic-primer-on-fda-subpoenas-7480482/U.S. Department of Health and Human Services. (2016). Conducting Clinical Investigations. https://www.fda.gov/media/82395/downloadEisner, A. (2021). Successfully Petitioning FDA to Quash or Limit a Subpoena. JD Supra. https://www.jdsupra.com/legalnews/successfully-petitioning-fda-to-quash-4449310/U.S. Food and Drug Administration. (2014). Regulatory Procedures Manual. https://www.fda.gov/media/71836/downloadU.S. Food and Drug Administration. (2018). Compliance Policy Guide Sec. 120.100 Guidance for FDA Staff and Industry: Collection of Records Requested Under the Food, Drug and Cosmetic Act. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-120100-guidance-fda-staff-and-industry-collection-records-requested-under-food-drug-andEisner, A. (2021). Responding to FDA Inspections, Subpoenas and Other Investigatory Requests. JD Supra. https://www.jdsupra.com/legalnews/responding-to-fda-inspections-9538882/