FDA Warning Letters (Overview & Response Strategies) - Medicare RAC Audits & Appeals Services
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FDA Warning Letters (Overview & Response Strategies)

FDA warning letter

The U.S. Food and Drug Administration (FDA) is tasked with enforcing several federal laws, most notably the Food, Drug, and Cosmetic Act (FD&C) and certain parts of the Public Health Service Act. The scope of these laws is massive, so the FDA has had to rely on less conventional enforcement techniques, like the FDA warning letter.

These warning letters inform recipients that the FDA believes that their conduct violates federal law. They describe the particular conduct at issue, specifies how this violates a law or regulation that the FDA enforces, and instructs the recipient on how to rectify the problem and voluntarily comply with the law.

Warning letters are often the first sign that the FDA is monitoring someone’s actions. While warning letters serve as prior notice that an FDA investigation may be forthcoming, they are still just advisory: They do not commit the FDA to action and do not present an objective view of the law. Instead, they communicate the FDA’s interpretation of the law and the FDA’s opinion that the recipient is violating it.

Nevertheless, FDA warning letters should be taken very seriously. They are often the opening maneuvers in an FDA fraud investigation or an FDA compliance audit. It is essential to hire an FDA fraud defense lawyer from Oberheiden, P.C. as soon as possible.

What is an FDA Warning Letter?

An FDA warning letter is an advisory opinion from the FDA. It states that the agency believes that the person receiving the letter has violated one of the laws or regulations that the FDA enforces – most often the FD&C (21 U.S.C. § 301 et seq.).

According to Chapter 4 of the FDA Regulatory Procedures Manual, warning letters generally:

  • Are titled “WARNING LETTER”
  • Are sent for overnight delivery, with return receipt documented to ensure delivery
  • Get addressed to the highest known official in the recipient’s company
  • Outline the FDA’s investigation or inspection, so far, including the dates they were conducted
  • Explain the conduct that violates the law in sufficient detail for the recipient to take corrective action
  • Cite the law or regulation that is allegedly violated by the conduct
  • Include any pertinent information on relevant post marketing requirements or clinical trials
  • Specify appropriate corrections that should be taken by the recipient
  • Request the recipient to investigate the issue and voluntarily make the appropriate corrections, and then provide a written response to the warning letter, often within 15 working days
  • Warn the recipient that failure to correct the conduct can lead to legal action
  • Inform the recipient how to challenge the FDA’s determination that the conduct violates the law

In addition to getting sent to the recipient, the warning letter will be posted on the FDA’s website for the public to see. This negative publicity can harm the recipient’s reputation, even if the claims in the letter are inaccurate.

What Should I Do if I Have Received One?

If you have received a warning letter from the FDA, the most important thing to do is to call a lawyer who has experience handling FDA investigations. The warning letter is generally the first step in an FDA investigation. Getting a lawyer involved early on can get ahead of the situation, determine the best course of conduct going forward, and mitigate the damage and inconvenience of an investigation.

In many cases, the conduct that the warning letter claims to be violating the law is inaccurate or a misrepresentation of what the recipient has been doing. In other cases, the FDA’s interpretation of a law or federal regulation is vague, controversial, or uncertain. Remember, courts have the final say in what the law means. The FDA’s interpretation of an unsettled point of law is not final.

An FDA defense lawyer can conduct an internal investigation of the conduct outlined in the warning letter and determine whether the conduct actually does violate the law. The defense team can then go through the appeals process to challenge the FDA’s action and potentially get the FDA to drop its investigation and let the recipient continue its activities. If the internal investigation finds wrongdoing, misconduct, or unintentional violations of the law, the defense team can help the recipient work with the FDA to resolve the dispute, minimize liability, and obtain a close-out letter from the FDA, acknowledging that the recipient is in compliance with the law.

What Can Happen if I Ignore a Warning Letter?

Recipients of an FDA warning letter who ignore the letter and continue the conduct outlined in the warning face a very high risk of an FDA investigation. The FDA will follow-up on its warning letters if no response is received, and will continue to investigate the alleged illegal conduct.

That investigation can lead to significant legal action, including:

  • Civil penalties
  • Seizure of products allegedly violating the law
  • Product recalls
  • Closure of business premises
  • An injunction to halt business operations
  • Criminal prosecution

Is the FDA Using Warning Letters More Often, Now?

In the past few months, the FDA seems to be sending more warning letters than it used to. Much of this increased enforcement looked to be focused on reining in misleading or fraudulent cures for the coronavirus (COVID-19), as well as new tobacco products related to vaping and electronic cigarettes.

Call an FDA Warning Letter Response Lawyer at Oberheiden P.C.

If you have received an FDA warning letter, it means that the FDA is monitoring your activities and thinks that they violate federal law. While the warning letter is not a formal criminal charge, it is still a very serious matter.

Hiring a lawyer is crucial.

The FDA warning letter response lawyers at Oberheiden, P.C. legally represent healthcare providers and professionals in federal compliance and law enforcement situations, including those overseen by the FDA. Our law firm is filled with former healthcare fraud prosecutors and FDA investigators who have an intimate knowledge of how the process works and how recipients of FDA warning letters can best react to the scrutiny of a powerful government agency.

Call us at 888-680-1745 or contact us online to get started on your defense.

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