The U.S. Food and Drug Administration’s (FDA) Office of Criminal Investigations (OCI), “protects the American public by conducting criminal investigations of illegal activities involving FDA-regulated products, arresting those responsible, and bringing them before the Department of Justice for prosecution.” 

These investigations are very different from routine audits and inspections—although all FDA inquiries can potentially lead to the same outcomes if they produce evidence of criminal misconduct. When facing an FDA investigation, there are both steps companies need to take and mistakes they need to avoid, and knowing what to do (and what not to do) is critical for achieving a favorable outcome. 

The FDA OCI has a number of stated priorities. However, these priorities are broad in scope; and, as such, they encompass virtually all activities falling within the FDA’s enforcement jurisdiction. As identified by OCI, the Office’s priorities include: 

• “Breaches in the legitimate medical supply chain by individuals and organizations dealing in unapproved, counterfeit, and substandard medical products;”

• “Criminal violations in situations where the normal regulatory process has been unable to remedy the problem;”

• “Criminal violations where the risk of harm to the public health is particularly significant and the only remedy appears to be through the criminal process;” and,

• “Criminal conduct that prevents the FDA from being able to properly regulate. This includes false statements to the FDA during the regulatory process and obstruction of justice.”

As you can see, rather than focusing on specific unlawful conduct (i.e. selling non-FDA approved medical devices or violating federal labeling requirements), the OCI focuses instead on targeting violations that present significant risk to the public and/or that cannot be remedied through administrative or civil enforcement action. Thus, facing an OCI investigation is a matter that needs to be taken very seriously, and companies must work with experienced FDA compliance and defense counsel to ensure that they protect themselves by all means available. 

“Investigations conducted by the FDA’s Office of Criminal Investigations can move quickly, and they can have severe consequences if they lead to charges being filed. As a result, those targeted by OCI need to make smart decisions, and they need to avoid mistakes that have the potential to lead to prosecution.” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden P.C.

What To Do When Facing an FDA Investigation 

Presenting a successful defense during an FDA investigation is a multi-step process that requires a clear and comprehensive understanding of the circumstances and allegations involved. With this in mind, some of the key steps for defending against an investigation conducted by OCI include: 

1. Determine Why OCI is Investigating 

One of the first things that needs to be done when facing an FDA investigation is to determine why OCI has deemed it necessary to investigate. With the breadth of the FDA’s enforcement jurisdiction and OCI’s investigative authority, understanding the scope and nature of an investigation is crucial to developing a targeted and effective defense strategy. 

2. Conduct an Internal FDA Compliance Assessment 

Once you have determined why OCI is investigating, then you can shift your efforts to determining what OCI’s investigators are going to find. This needs to be done as soon as possible. If your company is at risk due to statutory or regulatory violations, this is something you need to know as you work toward developing a defense strategy. 

3. Establish a Team and Chain of Command

When facing any type of government investigation, it is imperative to establish a team and chain of command. The team should be composed of company leaders and personnel who have relevant subject matter expertise—along with attorneys from the company’s FDA compliance and defense firm. Reporting responsibilities should be clearly established as well, and there should be clear lines of communication between all levels. 

4. Prepare for OCI’s Investigative Means

As discussed in the FDA’s Investigations Operations Manual, OCI investigators can gather information through a variety of different means. These include (but are not limited to) conducting interviews, reviewing records, collecting samples, and even using confidential informants. 

Companies facing OCI investigations need to prepare for all investigative means—from prepping personnel for interviews to protecting privileged records and ensuring that informants are not included on their response teams. 

5. Assert the Attorney-Client Privilege as Warranted

During an FDA investigation, many company records are likely to be protected under the attorney-client privilege. Companies facing investigations must work with their counsel to ensure that they assert the privilege appropriately. 

Memoranda, communications, policy and procedure recommendations, internal audit reports, and various other documents that may be highly relevant to OCI’s investigation may also be protected against involuntary disclosure. 

6. Evaluate Potential Means of Resolution 

After discerning the focus of the investigation, any potential risks, and all defenses the company has available, the next key step is to evaluate potential means of resolution. Is OCI’s investigation misguided—and does the company have the documentation it needs to prove it? Or, is there a risk that criminal charges could be forthcoming? 

Determining the answers to these types of questions is essential for moving forward with a defense strategy that targets a particular desired outcome. 

7. Focus on Achieving a Pre-Charge Resolution

In the vast majority of cases, an OCI investigation defense strategy should focus on achieving a pre-charge resolution. With that said, if a favorable pre-charge result is not in the cards, then it may be in a target’s best interests to prepare for the possibility of facing trial. 

By working strategically with OCI (and any other agencies involved in the investigation), it will often be possible to achieve a favorable result before charges get filed. While it will be possible to avoid liability entirely in many cases, in some circumstances a negotiated resolution may be warranted. 

What Not To Do When Facing an FDA Investigation

When facing FDA investigations, companies must also be extremely careful to avoid making mistakes that could increase their risk of prosecution. With this in mind, here are seven things not to do after being contacted by OCI: 

1. Assume You Know Why OCI is Investigating 

Even if you are aware of deficiencies in your company’s FDA compliance efforts, you should not assume that these deficiencies are the reason for OCI’s investigation. If you make this assumption – and if OCI is focused on other issues – not only will you be wasting time and resources “defending” against the wrong allegations, but you also won’t be defending against those that are putting your company at risk for prosecution. 

2. Ignore the Risks of Facing an FDA Investigation 

If OCI is investigating your company, this means that criminal charges are on the table. If prosecuted criminally, companies can face substantial fines, and company executives and other personnel can face fines and prison time. Working with the DOJ, OCI can pursue a broad range of criminal charges against companies and individuals—from health care fraud and other fraud crimes to Anti-Kickback Statute violations and conspiracy. 

3. Allow Personnel to Be Interviewed by OCI Without Preparation 

When OCI investigators request to interview your company’s personnel, it is essential to ensure that these personnel know what to expect. They also need to have a clear understanding of what they can say and what they should not say on your company’s behalf. As a result, preparation is key, and this should generally involve having these individuals sit down with the company’s FDA compliance and defense counsel. 

4. Grant Unfettered Access to Your Company’s Records 

OCI investigators will request access to your company’s records for purposes of their investigation. When granting access, it is imperative to only grant the access that is necessary to comply with OCI’s lawful demand. If OCI investigators have access to records, they will review them. If your company inadvertently provides access to records that support prosecution, this is a mistake that it may not be possible to correct. 

5. Be Cooperative To Your Disadvantage

While it will often be beneficial for companies to take a cooperative stance during FDA investigations, companies cannot be overly cooperative to their disadvantage. Company leaders and personnel need to know when to say “No,” and they must work closely with the company’s legal counsel to ensure that they are taking effective steps to mitigate the company’s (and perhaps their own personal) risk. 

6. Obstruct OCI’s Investigation 

On the same token, targets of FDA investigations must be careful to avoid obstructing the investigative process. Obstructing an investigation is itself a prosecutable offense, and mistakes ranging from destroying relevant records to making false statements to OCI investigators can have severe consequences. 

7. Wait To See if Charges Get Filed

Finally, one of the biggest mistakes companies can make when facing an FDA investigation is waiting to see if charges get filed. While waiting to engage defense counsel may seem like the cost-effective approach, it can be far more costly to try to defend against allegations in federal district court. By taking a proactive approach during the investigative process, targets of FDA investigations can not only significantly mitigate their risks, but they can often significantly reduce the cost of their defense as well.