What represents an FDA Consent Decree?

An FDA Consent Decree represents a serious step in FDA enforcement. To obtain a consent decree the FDA must work with the Department of Justice (DOJ) trial attorney to file a complaint in Federal District Court. This type of filing requires a response otherwise a default judgment will be entered against the defendant facility. In the majority of cases the defendant facility does not fight the allegations, but settles the matter through a FDA Consent Decree also known as an injunction.

The FDA injuction requires a complete halt in operations until certain conditions are met. This typically focuses on previous violations for labeling (misbranding) or Good Manufacturing Practices (GMPs; adulteration). A FDA Consent Decree will require corrections and verification audits passed prior to resuming operations. The injuction may also require a recall. The recall can be quite wide in scope covering lengthy periods of time for a single product or an entire inventory.

The best practice is to avoid the FDA taking this drastic step. Often this means engaging counsel to respond to FDA Warning Letters or Form 483s. Proactive, timely, and appropriate responses at early stages can keep a FDA injuction from occurring.

When the DOJ trial attorney becomes involved it is important to engage regulatory counsel and local trial counsel to negotiate the best possible outcome. The negotiation can focus on limiting the scope of the recall, for example, or expanding deadlines for various required action. The simple changes can make managing the implementation of the Consent Decree easier and more streamlined. Following the negotiations it is important to fully comply with a FDA injuction. Each deadline in the Consent Decree must be met.

It is important to remember, once an injuction is filed and issued by the Federal court, non-compliance becomes grounds for contempt. This places a greater emphasis on compliance than what is normally experienced in a Warning Letter or Form 483 scenario.