Protecting Your Business in the Face of Regulatory Scrutiny
Government investigations are an ever-present reality for companies operating in FDA-regulated industries. Whether you're in pharmaceuticals, medical devices, biologics, laboratories, food, cosmetics, veterinary, or cannabis, understanding the nuances of these investigations is critical for safeguarding your business and its reputation. This article distills key insights from a recent webinar led by David Graham, a seasoned litigator at Gardner Law specializing in FDA law and government investigations, offering valuable guidance for navigating this complex landscape.
KEY TAKEAWAYS
1. Inspections vs. Investigations:
It's important to differentiate between routine FDA inspections and targeted investigations. Inspections are generally scheduled and focus on overall compliance with Good Manufacturing Practices (GMPs), labeling requirements, and other relevant regulations. Investigations, however, are triggered by specific concerns or allegations and delve deeper into particular issues.
2. Triggers for Investigations:
Investigations can arise from a variety of sources, including:
- Employee interviews: Even seemingly casual conversations with employees during inspections can raise red flags and trigger further scrutiny.
- Whistleblowers: Disgruntled employees or individuals with knowledge of wrongdoing can initiate investigations.
- Competitor complaints: Competitors may report alleged violations to gain a competitive edge.
- News stories and media coverage: Negative publicity can attract regulatory attention.
- Referrals from other investigations: Information uncovered in unrelated investigations can lead to new inquiries.
- Adverse event reports: Reports of product defects, injuries, or other adverse events can trigger investigations.
- Data integrity concerns: Questions about the accuracy or reliability of data submitted to the FDA can prompt investigations.
3. Your Role in an Investigation:
You may find yourself in one of three roles during a government investigation:
- Target: This is the most serious position, indicating that the government is actively investigating your company for potential violations.
- Witness: You may possess information relevant to an investigation involving another entity.
- Informant: Your company might provide information to the government about a competitor or other industry player.
4. Preparing for the Unexpected:
Proactive preparation is crucial for effectively managing government investigations. This includes:
- Establishing a response team: Identify key personnel, including legal counsel, compliance officers, quality assurance experts, and IT specialists, who will be responsible for handling investigations.
- Training employees: Educate employees about their rights and responsibilities during interactions with government investigators.
- Implementing a robust document retention policy: Ensure compliance with record-keeping requirements and establish procedures for preserving documents relevant to potential investigations.
- Securing leadership buy-in: Ensure that company leaders understand the implications of government investigations and support the response plan.
5. Understanding Your Rights and Limitations:
While cooperation is generally advisable, it's important to remember that you have rights. These include:
- Fourth Amendment protections against unreasonable searches and seizures: Investigators cannot access your facilities or information without proper legal justification.
- Fifth Amendment right against self-incrimination: You are not obligated to provide information that could incriminate yourself or your company.
- Due process rights: You are entitled to fair treatment and the opportunity to defend yourself against allegations.
6. Initial Contact and Information Control:
When government investigators arrive, it's crucial to:
- Identify the investigators and their purpose: Request identification and any documentation explaining the reason for their visit.
- Notify your response team and legal counsel: Give your team time to assemble and prepare.
- Determine the scope of the investigation: Understand what information or individuals are of interest to the investigators.
- Control the flow of information: Limit access to sensitive information and ensure that communication is handled by designated personnel.
7. The Importance of Counsel:
"Government investigations can be complex and intimidating," says David Graham. "Having experienced legal counsel by your side is essential for navigating the process, protecting your rights, and ensuring the best possible outcome for your company."
