What to do during the FDA investigation?

The Office of Criminal Investigations (OCI) of the United States Food and Drug Administration (FDA) “protects the American public by conducting criminal investigations into illegal activities involving products regulated by the FDA, arresting those responsible and bringing them before the Ministry of Justice for prosecution. ”

These investigations are very different from routine audits and inspections, although all FDA investigations have the potential to lead to the same results if they produce evidence of criminal misconduct. In the face of an FDA investigation, companies must follow both steps and mistakes to avoid, and knowing what to do (and what not to do) is key to achieving a favorable outcome.

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

  • “Violations of the legitimate medical supply chain by individuals and organizations selling unapproved, counterfeit and substandard medical products; “

  • “Criminal offenses in situations where the normal regulatory process has not been able to remedy the problem; “

  • “Criminal offenses for which the risk of harming public health is particularly high and the only remedy appears to be criminal proceedings; ” and,

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

As you can see, rather than focusing on specific illegal conduct (i.e. selling non-FDA approved medical devices or violating federal labeling requirements), the OIC is focusing rather on targeting violations that present a significant risk to the public and / or that cannot be remedied by administrative or civil enforcement measures. Thus, facing an OIC investigation is an issue that should be taken very seriously, and companies should work with experienced FDA compliance and defense attorneys to ensure they are protecting themselves. by all means available.

“Investigations by the FDA’s Bureau of Criminal Investigations can move forward quickly and they can have serious consequences if they result in charges. Therefore, those targeted by the OIC should make sound decisions and avoid mistakes that could lead to prosecution. – Dr Nick Oberheiden, founding lawyer of Oberheiden PC

What to do about an FDA investigation

Presenting a successful defense during an FDA investigation is a multi-step process that requires a clear and complete understanding of the circumstances and claims involved. With this in mind, some of the key steps in defending against an OIC-led investigation include:

1. Determine why the OIC is investigating

One of the first things to do in the face of an FDA investigation is to determine why the OIC has found it necessary to investigate. Given the breadth of the enforcement jurisdiction of the FDA and the OIC investigative authority, it is essential to understand the scope and nature of an investigation to develop a targeted defense strategy and effective.

2. Conduct an internal FDA compliance assessment

Once you have determined why the OIC is investigating, you can then shift your efforts to determining what the OIC investigators are going to find. This should be done as soon as possible. If your business is at risk due to legal or regulatory violations, you need to know this when working on developing a defense strategy.

3. Establish a team and chain of command

When faced with any type of government investigation, it is imperative to establish a team and a chain of command. The team should be comprised of business leaders and staff with relevant subject matter expertise, as well as lawyers from the company’s FDA defense and compliance firm. Reporting responsibilities should also be clearly established and there should be clear lines of communication between all levels.

4. Prepare for OCI Investigative Resources

As stated in the FDA Investigative Operations Manual, OIC investigators can collect information through various means. These include (but are not limited to) conducting interviews, reviewing files, collecting samples and even using confidential informants.

Businesses facing OIC investigations should prepare for all investigative means, from preparing staff for interviews to protecting confidential records and ensuring that informants are not included in their teams. intervention.

5. Affirm solicitor-client privilege as guaranteed

During an FDA investigation, many company records are susceptible to solicitor-client privilege. Businesses facing investigations should work with their attorney to ensure that they are asserting the privilege appropriately.

Memoranda, communications, policy and procedural recommendations, internal audit reports, and various other documents that may be of great relevance to the OCI’s investigation may also be protected from unintentional disclosure.

6. Evaluate potential means of resolution

After discerning the purpose of the investigation, the potential risks, and any defenses available to the business, the next key step is to assess potential remedies. Is OCI’s investigation flawed and does the company have the documentation it needs to prove it? Or, is there a risk that criminal charges will be laid?

Determining the answers to these types of questions is essential to 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 investigative defense strategy of the OCI should focus on achieving a resolution prior to charge. That said, if a favorable outcome before the charge is not in the cards, it may be in a target’s best interest to prepare for the possibility of being tried.

By working strategically with the OIC (and any other body involved in the investigation), it will often be possible to achieve a favorable outcome before charges are laid. While it is possible to avoid liability entirely in many cases, in some circumstances a negotiated resolution may be warranted.

What not to do in the face of an FDA investigation

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

1. Suppose you know why the OIC is investigating

Even if you are aware of the gaps in your company’s FDA compliance efforts, you should not assume that these gaps are the reason for the OCI investigation. If you make this assumption – and if OCI focuses on other issues – not only will you waste time and resources “defending” against bogus claims, but you will also not be defending yourself against those that put your business in jeopardy. danger for pursuit.

2. Ignore the Risks of Facing an FDA Investigation

If the OIC is investigating your business, it means that criminal charges are on the table. If prosecuted criminally, companies can face substantial fines, and company executives and other staff can face fines and jail time. In collaboration with the DOJ, the OIC can prosecute a wide range of criminal charges against companies and individuals, ranging from healthcare fraud and other fraud offenses to violations of the anti-recoil law. and conspiracy.

3. Allow staff to be interviewed by OCI without preparation

When OIC investigators ask to interview your company staff, it is essential to make sure that these staff know what to expect. They should also have a clear understanding of what they can and shouldn’t say on behalf of your business. As a result, preparation is essential, and that should generally involve these people sitting down with the company’s FDA compliance and defense attorney.

4. Grant unlimited access to your company records

OCI investigators will request access to your business records for the purposes of their investigation. When granting access, it is imperative to alone grant access that is necessary to comply with OCI’s legal request. If the OCI investigators have access to the files, they will review them. If your company inadvertently gives access to documents supporting the lawsuit, this is an error that may not be possible to correct.

5. Be cooperative to your disadvantage

While it is often advantageous for companies to take a cooperative stance during FDA investigations, companies cannot cooperate too much to their detriment. Company executives and staff need to know when to say “No” and they should work closely with company legal counsel to ensure they are taking effective action to mitigate business risk. (and maybe their own).

6. Obstruct the OCI’s investigation

Likewise, the targets of FDA investigations must be careful not to obstruct the investigative process. Obstructing an investigation is itself a prosecutable offense, and errors ranging from destroying relevant records to making false statements to OCI investigators can have serious consequences.

7. Wait and see if any charges are laid.

Finally, one of the biggest mistakes businesses can make when faced with an FDA investigation is to wait and see if any charges are filed. While waiting to hire a defense lawyer may seem like a cost-effective approach, it can be far more costly to try to defend against claims in federal district court. By taking a proactive approach during the investigative process, the targets of FDA investigations can not only significantly mitigate their risk, but they can often also significantly reduce the cost of their defense.

Oberheiden PC © 2021 Revue nationale de droit, volume XI, number 245

Mark M. Gagnon