At the end of the day, FDA’s goal in sending a Warning Letter is to give you an opportunity for voluntary compliance.

Receiving a Warning Letter from FDA can seem daunting for any company regulated by FDA, including those offering food, drug, biologic, medical device and cosmetic products. As bad as receiving a Warning Letter may seem initially, some of the most respected companies in these industries have received Warning Letters. Ultimately, how a company responds to a Warning Letter is the difference between those who thrive and those who falter.    

A Warning Letter Is Informal and Advisory

As described by FDA in the agency’s Regulatory Procedures Manual, a Warning Letter is informal and advisory. Getting a Warning Letter does not mean that FDA will take enforcement action. The Warning Letter also does not necessarily represent FDA’s final position.

In other words, a Warning Letter is not “final agency action.” This has both positive and negative aspects. On the positive side, a company may avoid further agency action by responding in a proactive manner with a robust, science-based response. In contrast, a weak response will almost always result in greater scrutiny by FDA. Even if a company disagrees with the observations in a Warning Letter, a company cannot run to court to seek judicial relief because it is not “final agency action.”

The amount of time between FDA’s inspection and issuance of a Warning Letter has become an issue with FDA. With the growth of the pharmaceutical, biologics and medical device industries, as well as increasing complexity and new scientific breakthroughs leading to new products, this period of time has increased. The Regulatory Procedures Manual provides guidelines for FDA that a Warning Letter recommendation should be submitted to the reviewing office within 15 working days after completion of an inspection. Following that, the appropriate reviewing office should issue its decision on approving or disapproving the Warning Letter within 15 working days of receiving it. While all of that is happening behind the scenes at FDA, companies should be able to rest assured that if a Warning Letter is coming, it will be issued within about 30 working days after an inspection. But that rarely happens. It is often three to four months after an inspection until a Warning Letter is issued, and there are extreme cases of the issuance taking a year or more. Suffice it to say, if FDA thinks something is a danger to public health, they often act more quickly. Nevertheless, experienced legal counsel can often look at the observations in a Form FDA 483 (if one was issued following an inspection) and previous Warning Letters issued by the agency in similar circumstances in order to make a well-reasoned prediction as to whether FDA will likely issue a Warning Letter.

That being said, a Warning Letter is not a prerequisite to FDA enforcement action. Where FDA believes something a company is doing presents a reasonable possibility of injury to the public, FDA will take enforcement action beyond a Warning Letter. In situations of increased risk of injury, FDA will not wait for the time it takes to issue a Warning Letter and get a response. If FDA believes a product needs to be recalled, they will act immediately in requesting a recall.

At the end of the day, FDA’s goal in sending a Warning Letter is to give you an opportunity for voluntary compliance. In preparing the response to a Warning Letter, you should keep that idea front and center to show FDA your company’s commitment to quality and compliance by the actions you are prepared to take. The Warning Letter response is your opportunity to communicate back to the agency on the record.

Correct the Record

If the Warning Letter includes inaccurate facts, take this opportunity to correct the record. To the degree you can correct mistakes of fact during an inspection or by responding to observations in a Form 483, you should do so. We strongly urge our clients, however, to not commit in writing to the agency to take any action or agree to any recitation of fact prior to review by legal counsel. Also, if you believe there are any material facts not mentioned in the Warning Letter, your response is your chance to put those omitted facts in writing and explain why those facts matter. Even FDA is not perfect. Sometimes the facts recited in a Warning Letter are not fully accurate. Correcting material inaccuracies can make a huge difference. Similarly, if you (in consultation with a qualified lawyer) believe that FDA is misapplying laws or regulations, your response to the Warning Letter is the opportunity to explain why you believe certain regulations are being misapplied.

Remember to be practical and pragmatic, though. Telling FDA they got everything wrong is unlikely to go very far or help your cause. Be specific, provide proof and be selective. Always remember FDA will hold you to what you put in your response. You can also bet that, if litigation ensues, third parties will also hold you to your written responses.

Commitment to Quality and Compliance

The most important message to get across in any response to a Warning Letter is your commitment to quality and regulatory compliance. Say it explicitly, and then show FDA through specific corrective actions you are taking.

Voluntary corrective action is FDA’s goal in sending any Warning Letter. Even if you disagree with FDA on a factual or legal principle, consider what corrective actions you can take to improve. The more you can show specific, direct and prompt corrective action, the better off your company will be.

If you can, go above and beyond. When it makes sense for the quality of your product, consider exceeding the minimum regulatory requirements.

Follow Through and Move Forward

It almost goes without saying, but make sure to follow through on your commitments to corrective actions. Always provide FDA with proof that all corrective actions have been implemented. Once you’ve done that, carry your business forward knowing that you are in a better position and doing a better job than before the Warning Letter.

For More Information

If you have any questions about this Alert, please contact Frederick R. Ball, Patrick C. Gallagher, Ph.D., Robert M. Castle III, Coleen W. Hill, any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.