Friday, January 27, 2012

Warning Letter, AIP to Consent Decree - Isn't it better to follow GMPs ?

In continuation to my earlier post related to AIP featuring Ranbaxy's and FDA saga, the 'consent decree' might be the forward looking statement to both the parties. While FDA moves ahead with caution and pre-fixed direction, Ranbaxy makes firm committment towards its Quality Assurance program and prmomise to provide safe and quality medicines.

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.

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.

Historically many companies have been a part of consent decree and notably are Schering & Plough, J& J.

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