FDA warning letters can be the 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 PC has helped customers 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 responsible for ensuring that manufacturers of pharmaceuticals, medical devices, tobacco products, and other potentially harmful products meet their federal obligations. This includes compliance with laws such as the Food, Drug & Cosmetic Act of 1938 (FDCA), the Medical Device Amendments of 1976, and FDA regulations promulgated under these statutes.
To fulfill this mandate, the FDA inspects manufacturers’ products, marketing materials, and facilities; and when it discovers a potential violation, it takes action. Typically, the FDA’s first course of action is to send a warning letter to the manufacturer. As the FDA explains:
“When the FDA discovers that a manufacturer has materially violated FDA regulations, the FDA notifies the manufacturer. This notification often takes the form of a warning letter. The warning letter identifies the violation, such as poor manufacturing practices, problems with claims about what a product can do, or incorrect instructions for use. The letter also clearly states that the company must correct the problem and provides instructions and a timeframe for the company notifies the FDA of its remediation plans.
Upon receipt of a warning letter from the FDA, it is imperative that a manufacturer takes appropriate action. A warning letter indicates that the FDA has discovered violations of the FDCA or other relevant authority, and it indicates that the FDA will take enforcement action if the manufacturer does not voluntarily remedy violations in a timely manner.
“An FDA warning letter is a serious event. If the manufacturer responds appropriately, it can avoid the risk of enforcement action resulting from identified statutory or regulatory violations. However, if he does not respond appropriately, this failure can potentially exacerbate the consequences of the initial non-compliance. – Dr. Nick Oberheiden, founding lawyer of Oberheiden PC
Because FDA enforcement action can have significant ramifications, manufacturers who receive warning letters should respond appropriately. However, this does not necessarily means taking action to do what the FDA has asked. In some cases, the warning letters are wrong; and, rather than expending significant resources on fixing a problem that doesn’t exist, manufacturers would be better off working proactively with the FDA to come up with a more reasonable (and less expensive) solution.
Steps to Respond to an FDA Warning Letter
With these preliminary considerations in mind, and recognizing that each individual case requires 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 a warning letter from the FDA is to review the letter in detail. The manufacturer must know what the FDA is alleging and he must know why. He also needs to know how long he needs to respond, and he needs to know what kind of response the FDA is asking for (and by what means).
FDA warning letters are usually detailed enough for manufacturers to investigate FDA claims and come to an informed conclusion about their validity. Deadlines are usually highlighted in bold and can be short. In a recent example, the FDA sent a warning letter to a company accused of selling fraudulent COVID-19 treatments on Amazon, and it demanded a response within 48 hours.
Step 2: Conduct an internal investigation (and preferred by lawyer and client)
After reviewing the warning letter, the next step is to conduct an internal investigation. This investigation must be conducted under the supervision of outside counsel in order to establish solicitor-client privilege, and its objectives must be twofold.
First, the investigation should seek to verify or refute the FDA’s claims. Depending on whether or not the investigation supports the FDA’s claims, two very different answers might be needed. Second, the investigation should seek to uncover the reasons for the alleged violations (if they can be proven) so that the manufacturer can remedy them accordingly.
Step #3: Determine an Appropriate First Response to the FDA
Then the manufacturer must determine an appropriate initial response to the FDA, with the caveat that if the internal investigation cannot be completed by the FDA deadline, the initial response shall prevail. Due to the legal implications involved (including the potential for enforcement action), the manufacturer should work with its outside counsel to develop 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 required and it is possible to take (or at least begin) the corrective action before responding to the warning letter, then an appropriate initial response could indicate that the manufacturer is working in good faith to respond to FDA concerns. On the other hand, if the FDA’s claims are unfounded, an appropriate initial response may contain respectful objections with a request to meet and confer or with an indication that additional information will follow.
Step 4: Respond within the timeframe specified in the warning letter
No matter how much information the manufacturer may uncover during the window between receipt of the warning letter and the FDA’s response deadline, it must respond by the deadline. As FDA warning letters typically state, “Failure to properly address this issue may result in legal action, including, but not limited to, seizure and injunction.” If you cannot take action to completely resolve this issue within [the deadline]state the reason for the delay and the time frame in which you will do so.
Step 5: Determine appropriate next steps
Once the manufacturer has met its initial response obligation, it should then focus on determining the appropriate next steps. Again, what this entails will heavily depend on the merits of the FDA claims. If the claims are substantiated, the appropriate next steps may simply be to comply with FDA requirements. But, if they don’t, 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 erroneous conclusions (if warranted)
The FDCA, FDA regulations, and other sources of legal authority that govern manufacturers’ practices are extremely broad. They are also dense, complicated and confusing. As a result, even the FDA gets it wrong from time to time. Also, when the FDA issues a warning letter, it can only act on the information it has, and often that information doesn’t tell the whole story.
When a manufacturer disputes the claims of 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 warning letter is wrong in a respectful, non-confrontational manner, it can go a long way to avoiding any investigation or enforcement activity. Conversely, if the manufacturer is unnecessarily hostile, it can backfire and embolden the FDA in its resolve to find something to pursue.
Step 7: Take other reactive measures (if necessary)
A step back, if the FDA findings are do not misguided, the manufacturer will have to concentrate on taking any other necessary reactive measures. The nature and scope of the issues at stake will determine what exactly this entails. In some cases, manufacturers will simply have to modify their marketing materials (although this is often easier said than done). In others, manufacturers may need to halt production and pull products from shelves while they seek FDA approval.
This brings up another important point: FDA warning letters can address a very wide range of issues. Although warning letters generally provide sufficient guidance to manufacturers, as noted above, it is not always the case. When faced with possible enforcement actions, manufacturers cannot afford to make assumptions; and, even if taking reactive action costs a manufacturer hundreds of thousands or millions of dollars, it could still be worth it.
Step 8: Take further corrective action internally (if necessary)
In addition to taking reactive action, manufacturers who need to address compliance deficiencies identified in FDA warning letters should also determine if further corrective action is needed. Among other things, this will typically involve reassessing and updating the manufacturer’s FDA compliance program.
Step 9: Assess any potential risk of enforcement or private civil lawsuits
Although a manufacturer may avoid enforcement action by the FDA by responding to a warning letter, this does not necessarily mean that the manufacturer is immune from liability arising from deficiencies identified in the letter. Violations of the FDCA and other consumer protection laws may also result in private civil lawsuits, and it is entirely possible that other federal authorities may consider enforcement action against the company or its officers.
Step #10: Assemble a defense strategy (if needed)
Finally, if the allegations underlying an FDA warning letter pose a risk of civil or criminal litigation, the manufacturer should work with its outside counsel to develop a comprehensive and cohesive defense strategy. The FDCA and other violations of the law 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 main steps to follow in responding to an FDA warning letter. Manufacturers (and their legal advisors) should keep in mind that each individual situation requires a tailored approach, and what is needed for a manufacturer to avoid unnecessary liability following an FDA investigation depends on the specific circumstances presented.