FDA is now accepting
Public Comments on Librela

A Citizen Petition is a formal request submitted to the FDA asking the agency to take a specific regulatory action, such as reviewing safety data, updating labeling, or changing oversight of an approved product. The FDA is required by law to review the petition and issue a formal response, typically within 180 days of submission.

It becomes part of the official administrative record and requires the FDA to evaluate the issues raised and issue a formal response.

An adverse event report and a Citizen Petition serve very different purposes.

An adverse event report documents what happened to a specific animal after receiving a drug. It becomes part of the FDA's safety database and helps regulators identify potential safety signals.

A Citizen Petition asks the FDA to take specific regulatory action based on broader evidence and concerns. In this case, the petition requests measures such as enhanced warnings, additional safety studies, improved informed consent, stronger post-market surveillance, and other protections for pets and their owners.

A public comment allows you to share your experience, observations, or opinions directly with FDA decision-makers as they evaluate the issues raised in the petition. The more relevant information the FDA receives from affected pet owners, veterinarians, and other stakeholders, the more complete the record becomes.

In short: An adverse event report tells the FDA what happened. A Citizen Petition asks the FDA what should be done about it. Public comments help inform that decision.

There is no category that perfectly describes this Citizen Petition. The closest and most appropriate option appears to be "Drug Industry (C0022)."

Don't worry too much about this selection. The most important thing is that your comment is submitted and becomes part of the public record. The FDA will review comments based on their content, regardless of which available category is chosen.

The FDA generally has 180 days from the filing date of the Citizen Petition (June 1, 2026) to issue a response, which means comments can be submitted throughout much of that review period.

That said, earlier is better. Comments submitted in the early stages of the review process are more likely to help shape the FDA's evaluation of the issues raised in the petition. Early participation also demonstrates the level of public interest and urgency surrounding the concerns being presented.

If you plan to comment, we strongly encourage you to do so as soon as possible rather than waiting until the end of the review period. Every voice helps build the administrative record the FDA will consider when evaluating the petition.

Write in your own words. There is no required format and you do not need to be a veterinarian, scientist, or lawyer to participate.

You may wish to describe:

• Your pet's experience with Librela or Solensia, incuding adverse effects, or concerns you observed

• Whether you felt you received sufficient information to make an informed decision

• Why you support or oppose the actions requested in the Citizen Petition

• Any recommendations you believe would improve veterinary drug safety and transparency

The most effective comments are honest, factual, and based on your own experience or professional observations.

Yes. Public comments are not limited to adverse event reports. Anyone with an interest in veterinary drug safety, informed consent, transparency, post-market surveillance, or animal welfare may submit a comment.