Ranbaxy Forfeits Exclusivity for Three ANDAs Under Consent Decree
The FDA’s consent decree for Ranbaxy requires third-party audits of four facilities and it can be expanded to other plants if future inspections reveal compliance or data integrity issues, making it “unprecedented in scope,” the Department of Justice (DOJ) says.
Justice filed the decree Jan. 25 on behalf of the FDA to resolve manufacturing and data integrity problems at the company’s plants — three in India and one operated in the U.S. by OTC subsidiary Ohm Laboratories.
The decree, first announced in December, prevents Ranbaxy from manufacturing drugs for the U.S. market at the three cited Indian plants as well as the Ohm Laboratories plant in Gloversville, N.Y., until manufacturing meets U.S. drug quality standards.
During its investigation, DOJ found that Ranbaxy submitted false data in drug applications to the FDA, including backdating tests and submitting test data for which no test samples existed.
False data in clinical trials isn’t new. What is new is the aggressive role the FDA expects drug and device companies and CROs to play.
Under a proposed rule, the FDA says clinical trial sponsors must be proactive in reporting data that is even possibly false. But while it’s clear that noncompliant sponsors will face harsh prosecution, it’s less clear exactly what to report, how … and when.
This is not the time for guesswork. Act now to make the changes that will help protect you and your trials.
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