Navigating Government Investigations in FDA-Regulated Industries

Government investigations are an increasingly common reality for companies operating in highly regulated industries like pharmaceuticals, medical devices, and food production. This article summarizes key takeaways from a presentation by David Graham, an experienced attorney in this field, on how to effectively prepare for and respond to such investigations.

1. Understand the Different Types of Investigations

Government investigations can be civil, criminal, or both, often involving multiple agencies and jurisdictions. It's crucial to distinguish between routine inspections and targeted investigations, as each requires a different approach. Inspections focus on general compliance with regulations, while investigations typically stem from specific complaints, whistleblower tips, or other triggers.

2. Prepare for the Unexpected

Proactive preparation is key to successfully navigating government investigations. Companies should establish an internal response team comprising legal counsel, compliance officers, quality control personnel, and potentially other relevant stakeholders. This team should be trained on how to handle unexpected visits from investigators, including verifying credentials, gathering information about the purpose of the visit, and notifying appropriate personnel.

3. Protect Company and Individual Interests

While cooperation with government investigators is essential, companies must also protect their own interests and those of their employees. This involves understanding the limitations of the government's authority, asserting legal rights when necessary, and maintaining attorney-client privilege. Engaging experienced counsel who understands the intricacies of government investigations is crucial in this regard.

4. Manage Information Flow

Controlling the flow of information within the company during an investigation is vital. Establishing a clear protocol for communicating with employees and limiting access to sensitive information can help prevent misunderstandings and protect the company's reputation.

5. Document Retention and Legal Counsel

Maintaining an updated document retention policy and ensuring compliance with it is essential. In the event of an investigation, it may be necessary to suspend regular document destruction procedures. Legal counsel can provide guidance on document retention and production, as well as other legal issues that may arise during the investigation.

Additional Considerations

Companies may also want to identify outside consultants, such as experts in quality control or government regulations, who can provide additional support during an investigation. Public relations professionals can also be helpful in managing external communications, if necessary.

Conclusion

Government investigations can be daunting, but by being prepared and understanding the legal landscape, companies can navigate them effectively while minimizing disruption to their operations and protecting their interests.