What should a regulatory professional do when management insists on including a claim in labeling, but the FDA proposes a more restrictive claim?

When faced with a situation where management wants to include a specific claim in labeling but the FDA is suggesting a more restrictive claim, negotiating with the review division is the most appropriate step for a regulatory professional to take. This approach allows for a dialogue with the FDA, where regulatory professionals can discuss both the science and the reasoning behind the requested claims, advocate for their position, and potentially reach a compromise that would satisfy both the company’s goals and regulatory standards.

Negotiation can help to clarify misunderstandings or provide additional context that may support the broader claim. It also demonstrates a commitment to adhering to regulatory guidelines while still seeking to advance the company's objectives. Engaging with the review division fosters a collaborative relationship, which can be beneficial for both the company and the regulatory body in the long run.

Choosing to disregard FDA input or agreeing with management without consideration for regulatory guidance could lead to compliance issues and potential repercussions. Filing a formal complaint would not be a productive action in this context, as it may escalate tensions without contributing to a resolution. Submitting the claim as is would risk rejection or further delay in the approval process if it does not align with FDA expectations. Thus, negotiating is the most strategic and compliant path forward in dealing with discrepancies between internal management decisions and regulatory