Ranbaxy Labs Gets A Sweeping Consent Decree

Ranbaxy Labs Gets A Sweeping Consent Decree

January 26th, 2012 // 2:01 pm @

Filing false data with the FDA can cause problems. Just ask Ranbaxy Laboratories, which last month agreed to pay a $500 million fine and accept a consent decree for a raft of manufacturing violations (back story). Now, the US Department of Justice has released more details – the feds have filed a consent decree for a permanent injunction that prevents the Indian drugmaker from making meds for the US market until certain facilities meet US standards.

In announcing the consent decree, the feds are calling the move unprecedented. “This action against Ranbaxy is groundbreaking in its international reach – it requires the company to make fundamental changes to its plants in both the United States and India,” Tony West, Assistant Attorney General for the Justice Department’s Civil Division, says in a statement.

The Indian plants that West refers are located in Paonta Sahib, Batamandi and Dewas, which were placed on an FDA import alert in 2008. The US facility was based in Gloversville, New York, but has already been closed. However, other Ranbaxy facilities are not covered by the consent decree, notably a Princeton, New Jersey, plant that makes generic Lipitor.

What kind of problems did the feds find? The list is long: a failure to keep written records showing that drugs had been manufactured properly; a failure to investigate evidence indicating that drugs did not meet their specifications; a failure to adequately separate the manufacture of penicillin drugs from non-penicillin drugs in order to prevent cross-contamination; a failure to have adequate procedures to prevent contamination of sterile drugs; and inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date, according to the feds.

Moreover, Ranbaxy submitted false data in drug applications to the FDA, including backdating tests and submitting test data for which no test samples existed. These actions violated the federal Food, Drug and Cosmetic Act, which meant many Ranbaxy drugs were adulterated, potentially unsafe and illegal to sell in the US, the feds say. The fabricated bioequivalence and stability data, by the way, was used to support AIDS drugs to be paid for by the President’s Emergency Plan for AIDS Relief program (PEPFAR) and distributed to foreign countries (back story).

So what does Ranbaxy have to do? The drugmaker, which is now owned by Daiichi Sankyo, must remove false data contained in past drug applications and, of course, not submit any more false data to the FDA. So Ranbaxy must hire an outside expert to conduct an internal review at the affected facilities and audit applications containing data from those facilities; withdraw any applications found to contain false data; set up a separate office of data reliability, and hire an outside auditor to audit the affected facilities in the future, the feds say.

Meanwhile, Ranbaxy has agreed to relinquish any 180-day marketing exclusivity that it may have for three pending generic drug applications, and the drugmaker has also agreed to relinquish any 180-day marketing exclusivity that it may have for several additional generic drug applications – if it fails to meet certain decree requirements by specified dates, according to the FDA.

Three Ranbaxy execs were also named as defendants, by the way. They are: Dale Adkisson, senior vice president, head of global quality; Arun Sawhney, chief executive officer and managing director, and Venkatachalam Krishnan, who is regional director for the Americas.

There are exceptions for making drugs in the US, however. These include making meds to be used in clinical trials under investigational new drug applications or for bioavailability or bioequivalence testing. Ranbaxy can also make limited quantities for preparing or supporting an drug application to the FDA or meds specifically for conducting “non-clinical laboratory studies” or other research and testing that does not involve human subjects. And finally, Ranbaxy can distribute drugs that are made by third parties or meds that do not require any manufacturing activities.

[UPDATE: Despite the restrictions, one industry observer says the consent decree does not go far enough. “When the US government came knocking, Ranbaxy lied about it and dragged its heels, causing unknown danger to the world’s sickest and poorest HIV/AIDS patients. Now the company is being allowed to merely pay a fine and have its facilities reinspected and audited by a third party? That’s it? No one is going to jail?” says Patrick Burns of Taxpayers Against Fraud, a non-profit.

“Why has this generic foreign drug manufacturer not been permanently excluded from doing business with the US government, especially since it has been bought by Japanese drug manufacturer Daichi? Allowing the Ranbaxy brand to return to America’s store shelves under any circumstances is a major mistake. If we wink at this kind of abuse, we might as well walk around the global pharmaceutical marketplace with a giant ‘Kick Me’ sign on our back.”]

The decree, which remains subject to court approval, does permits FDA to order additional Ranbaxy facilities to be covered by the decree if the agency discovers through an inspection that the facility is not operating in compliance with the law and/or has serious data integrity issues, an FDA statement says.

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