FDA Consent Decree: What are they and How to deal with them!
If we could give you one piece of advice regarding a consent decree it would be this: Never get to the position where you are faced with one!! However, if you are in the position where you have one or about to receive one, there are some things that you can do make the process go much smoother.
What is a Consent Decree?
A consent decree is an order issued by a judge that expresses a voluntary agreement by the participants in a lawsuit. Sometimes a suit ends when a judge issues a consent decree, or a consent judgment. This is especially the case when the decree is issued after one side of the case voluntarily agrees to cease a particular action without admitting to any illegality of the action.
Recognized by Court
For an agreement between two parties to be considered binding and legal, it must also be recognized by the court. A consent decree, in this case, is judicial recognition of the agreement. The decree often bars one side of the case from certain actions.
A consent decree (also referred to as a consent order or stipulated judgment or agreed judgment) is:
Once entered, a consent decree is binding on the consenting parties and cannot be reviewed except on a showing that the consent was obtained by fraud or that the decree was based on mutual error or a failure of consent.
If the party against whom the judgment is rendered violates the terms of the consent decree, the judgment is as binding as any other, and the non-breaching party may seek enforcement through a contempt action. Enforcement actions vary, but can (and often do) include monetary penalties.
If a firm has repeatedly violated cGMP requirements, the FDA may make a legal agreement with the firm to force them to make specific changes; the agreement, the consent decree, is enforced by the federal courts.
Usually, consent decrees include fines (“disgorgements”), reimbursements to the government for inspection costs, due dates for specific actions, and penalties for noncompliance. Consent decrees usually are permanent, but at times specified in the agreement when the firm has achieved compliance, it can petition the court to remove the decree.
Video Overview On How To Handle A Consent Decree
Learn More About FDA Consent Decrees