FDA Warning letters can be harbinger of formal civil and criminal investigations. If your business receives such a notice of non-compliance from the FDA, you should immediately contact an experienced FDA defense attorney. Oberheiden P.C. has helped clients across the United States respond to FDA Warning Letters and ensured FDA compliance. This article summarizes a step-by-step response based on the successful resolution of a recent FDA case for one of our FDA litigation defense clients.

Among its many responsibilities, the U.S. Food & Drug Administration (FDA) is tasked with ensuring that manufacturers of pharmaceuticals, medical devices, tobacco products and other potentially harmful products meet their federal obligations. This includes complying with laws such as the Food, Drug & Cosmetic Act of 1938 (FDCA), the Medical Device Amendments of 1976, and the FDA’s regulations promulgated under these statutes.

To meet this mandate, the FDA inspects manufacturers’ products, marketing materials, and facilities; and when it uncovers a potential violation, it acts. Typically, the FDA’s first course of action is to issue a Warning Letter to the manufacturer. As the FDA explains:

“When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform FDA of its plans for correction.”

Upon receiving a Warning Letter from the FDA, it is imperative that a manufacturer take appropriate responsive action. A Warning Letter indicates that the FDA has uncovered violations of the FDCA or other pertinent authority, and it indicates that the FDA will initiate enforcement action if the manufacturer fails to voluntarily address the violations in a timely manner.

“A Warning Letter from the FDA is a severe event. If the manufacturer responds appropriately, it can avoid the risk of enforcement action resulting from identified statutory or regulatory violations. However, if it fails to respond appropriately, this failure can potentially exacerbate the consequences of the initial non-compliance.” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden P.C.

As an FDA enforcement action can have substantial ramifications, manufacturers that receive Warning Letters must respond appropriately. However, this does not necessarily mean jumping into action to do what the FDA has asked. In some cases, Warning Letters are misguided; and, rather than devoting significant resources to fixing a problem that doesn’t exist, manufacturers will be better off working proactively with the FDA to reach a more reasonable (and less costly) solution.

Steps Involved in Responding to an FDA Warning Letter

With these preliminary considerations in mind, and recognizing that each individual case calls for an assessment of the specific legal and factual issues involved, the broad steps involved in responding to an FDA warning letter are as follows:

Step #1: Review the Warning Letter in Detail

The first step after receiving an FDA Warning Letter is to review the letter in detail. The manufacturer needs to know what the FDA is alleging, and it needs to know why. It also needs to know how long it must respond, and it needs to know what type of response the FDA is requesting (and through what means).

FDA Warning Letters are usually detailed—enough so that manufacturers can investigate the FDA’s allegations and reach an informed conclusion about their validity. Deadlines are typically emphasized with bold lettering, and they can be short. In one recent example, the FDA sent a warning letter to a company accused of selling fraudulent COVID-19 treatments on Amazon, and it requested a response within 48 hours.

Step #2: Conduct an Internal (and Attorney-Client Privileged) Investigation

After reviewing the Warning Letter, the next step is to conduct an internal investigation. This investigation should be conducted with the oversight of outside counsel to establish the attorney-client privilege, and its purposes should be twofold.

First, the investigation should seek to either verify or disaffirm the FDA’s allegations. Depending on whether the investigation substantiates the FDA’s allegations, two very different responses could be necessary. Second, the investigation should seek to uncover the reasons for the alleged violations (if they can be substantiated) so that the manufacturer can address them accordingly.

Step #3: Determine an Appropriate First Response to the FDA

Next, the manufacturer must determine an appropriate first response to the FDA—with the caveat that if the internal investigation cannot be completed before the FDA’s deadline, then the initial response should take precedence. Because of the legal implications involved (including the potential for enforcement action), the manufacturer should work with its outside counsel to craft an appropriate written response.

What is considered an “appropriate” response to an FDA Warning Letter? The answer depends on the circumstances involved. If corrective action is necessary and it is possible to take (or at least begin) the corrective action before responding to the Warning Letter, then an appropriate initial response might indicate that the manufacturer is working in good faith to address the FDA’s concerns. On the other hand, if the FDA’s allegations are unfounded, then an appropriate initial response might contain respectful objections with a request to meet and confer or with an indication that additional information will follow.

Step #4: Respond by the Deadline Stated in the Warning Letter

No matter how much information the manufacturer can uncover during the window between receipt of the Warning Letter and the FDA’s response deadline, it must respond by the deadline. As the FDA’s Warning Letters typically state, “Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction. If you cannot take action to address this matter completely within [the deadline], state the reason for the delay and the time within which you will do so.”

Step #5: Determine Appropriate Next Steps

Once the manufacturer satisfies its initial response obligation, it then needs to focus on determining appropriate next steps. Again, what this entails will depend heavily on the merit of the FDA’s allegations. If the allegations have merit, then appropriate next steps may simply involve complying with the FDA’s demands. But, if they do not, then the more prudent approach may be to engage in an interactive or iterative process with the FDA.

Step #6: Work with the FDA to Correct Any Misguided Conclusions (If Warranted)

The FDCA, FDA regulations, and other sources of legal authority that govern manufacturers’ practices are extraordinarily broad. They are also dense, complicated, and confusing. As a result, even the FDA gets things wrong from time to time. Additionally, when the FDA issues a Warning Letter, it can only act on the information it has available, and oftentimes this information will not tell the whole story.

When a manufacturer disputes the allegations in an FDA Warning Letter, it will generally be prudent to try to work with, rather than against, the FDA. If the manufacturer can explain why the FDA’s Warning Letter is misguided in a respectful and non-confrontational manner, this can go a long way toward staving off further inquiry or enforcement activity. Conversely, if the manufacturer is unnecessarily hostile, this can have the opposite effect and embolden the FDA in its resolve to find something to prosecute.

Step #7: Take Further Responsive Action (If Necessary)

Taking a step backward, if the FDA’s conclusions are not misguided, then the manufacturer will need to focus on taking any further responsive action that is necessary. The nature and scope of the issues at hand will determine what exactly this entails. In some cases, manufacturers will simply need to modify their marketing materials (although this is often easier said than done). In others, manufacturers may need to halt production and pull products off of the shelves while they seek FDA approval.

This brings up another important point: FDA Warning Letters can address an extremely broad array of issues. While Warning Letters will typically provide sufficient guidance for manufacturers, as noted above, this isn’t always the case. When facing possible enforcement action, manufacturers cannot afford to make assumptions; and, even if taking responsive action costs, a manufacturer hundreds of thousands or millions of dollars, it could still be well worth it.

Step #8: Take Further Corrective Action Internally (If Necessary)

In addition to taking responsive action, manufacturers that need to address compliance deficiencies identified in FDA Warning Letters also need to determine if further corrective action is necessary. Among other things, this will typically involve re-evaluating and updating the manufacturer’s FDA compliance program.

Step #9: Assess Any Potential Risk for Enforcement Action or Private Civil Litigation

Even if a manufacturer can avoid FDA enforcement action by responding to a Warning Letter, this does not necessarily mean that the manufacturer is immune from liability arising out of the deficiencies identified in the letter. Violations of the FDCA and other consumer protection statutes can lead to private civil litigation as well, and it is entirely possible that other federal authorities could be considering enforcement action against the company or its executives.

Step #10: Assemble a Defense Strategy (If Necessary)

Finally, if the allegations underlying an FDA Warning Letter present a risk for civil or criminal litigation, the manufacturer must work with its outside counsel to assemble a comprehensive and cohesive defense strategy. FDCA and other statutory violations can create substantial liability exposure and executing a proactive defense strategy can significantly mitigate the risks involved.

This is just a general overview of the primary steps involved in responding to an FDA Warning Letter. Manufacturers (and their legal counsel) must keep in mind that each individual situation requires a custom-tailored approach, and what is necessary for a manufacturer to avoid unnecessary liability as the result of an FDA inquiry depends on the specific circumstances presented.