The Ranbaxy Laboratories regulatory saga is nearing an end. The Justice Department announced a "groundbreaking" consent decree that requires the Indian drugmaker to make "fundamental changes" to plants in the U.S. and India. The company won't be allowed to sell products made at certain facilities until problems there are corrected. It has to give up its sought-after 180-day exclusivity on three drugs--their identities filed under seal--and perhaps relinquish those rights on three more if it doesn't meet certain milestones.
Part of the reason for such a sweeping decree is Ranbaxy violated one major no-no in drugmaking: It falsified data submitted to the FDA. As part of the deal, Ranbaxy has to set up internal safeguards to make sure fake data doesn't make its way into company filings again. It also has to go back and audit any FDA applications produced by the suspect facilities. If auditors find false data, then those applications must be withdrawn.
The company's quality-control problems were serious, too. The Justice Department cites a lack of proper procedures to prevent contamination of sterile drugs and to keep penicillin meds from contaminating non-penicillin drugs. Ranbaxy also didn't adequately test for drugs' potency or investigate evidence that some drugs didn't meet specifications, the agency said.
"Submitting false data to the FDA in drug applications will not be tolerated," Assistant Attorney General Tony West said in a statement. "The Department of Justice, in partnership with the FDA, will use all available tools, including civil injunction actions and consent decrees, to ensure the integrity of drug applications, and to ensure that all drugs sold in the U.S. meet U.S. standards."
The decree ends more than three years of wrangling over Ranbaxy's manufacturing violations. The FDA announced in December 2008 that U.S. Marshals had seized Ranbaxy shipments and 30 of the company's drugs would be barred from the country. Since then, Ranbaxy has been negotiating with the FDA--and the DoJ has been investigating--in a process that caused considerable nail-biting at Daiichi Sankyo, which bought controlling interest in the Indian drugmaker a short time before the regulatory snafu.
The drama continued as the expiration date on Pfizer's ($PFE) Lipitor patent neared. Ranbaxy had 180-day exclusivity for its version of the drug, but whether it could get FDA approval remained an open question. Rumors flew until the company announced Dec. 1 it had launched its copycat version. The decree won't affect Ranbaxy's Lipitor marketing, officials say. Which is a good thing, considering the company had to set aside $500 million to cover its government settlements.
- read the DoJ release
- get the Ranbaxy statement
- see the story from AFP
- check out the Bloomberg coverage