FDA will lift a portion of its import alert for generic drugs made in two of Ranbaxy's facilities to allow the company to import antiviral ganciclovir to avoid a drug shortage.

The agency now restricts the import of 26 finished drugs and seven APIs produced in Ranbaxy's Dewas and Paonta Sahib manufacturing facilities after the company failed to meet FDA's cGMP requirements.

Most of the drugs on the import alert list, including loratadine and simvastatin, have multiple manufacturers, but Ranbaxy is the sole supplier to the U.S. of ganciclovir in capsule form. FDA will ask Ranbaxy to take additional measures to ensure the safety and quality of the product.

"FDA will work with Ranbaxy to develop and implement these controls. FDA must be satisfied that the specific controls Ranbaxy implements will assure that each batch of ganciclovir is manufactured and tested so that the product will be expected to meet its specifications," FDA said in an interview.

The agency stressed it found existing drugs made in the two factories met specifications and found no evidence of harm to patients, urging patients not to discontinue therapy.

"[We] have no reason to believe the drugs already in the U.S. from these plants pose a safety problem," Center for Drug Evaluation and Research Deputy Director Douglas Throckmorton said during a Sept. 16 press conference.

FDA also issued two warning letters Sept. 16 to Ranbaxy for the two facilities' cGMP deviations.

After Ranbaxy responded in April to FDA's findings of a January 2008 inspection of the Dewas plant, the agency said in a warning letter the company still failed to establish defined areas for production of non-penicillin beta-lactam products to prevent contamination, failed to properly record batch information, failed to properly review batch discrepancies, and failed to ensure quality and purity specifications and design procedures to prevent microbiological contamination.

In its second warning letter, FDA said it found the Paonta Sahib site to maintain inaccurate equipment cleaning records, incomplete batch production information and inadequate procedures to ensure packaging and labeling production.

The Paonta Sahib plant also received a warning letter in 2006 after FDA found isotretinoin capsules made by Ranbaxy had a decreased potency.

The agency drew criticism from House Energy & Commerce Committee Chairman John Dingell, D-Mich., for not issuing a recall or import alert for Ranbaxy products after discovering the GMP violations.

FDA said its most recent inspection, unlike the 2006 inspection, justified the response.

"We did not believe in June 2006 that the deficiencies rose to the level that an import alert was justified, CDER Office of Compliance Director Deborah Autor said during the press call.

"The Ranbaxy case is just more proof that FDA and particularly its Center for Drug Evaluation and Research have abandoned their mission," Energy and Commerce Subcommittee on Oversight and Investigations Chairman Bart Stupak, D-Mich., said in a Sept. 16 statement.

Ranbaxy is currently embroiled in a U.S. Department of Justice investigation for allegedly conducting "systematic fraudulent conduct" for concealing GMP violations (Also see "Ranbaxy Will Produce Internal Audits To U.S. DOJ But Warns Of Impact To Industry From "Bad Policy"" - Scrip, 15 June, 2008.).

"Today's action is the next step in our ongoing civil investigation. ….The criminal case is on a separate track and the timing of today's action is not related one way or another. We have done what we think is the appropriate next step in our regulatory investigation, and I'm sure they will continue to pursue the criminal investigation as they think appropriate," Autor said.

- Daniel Poppy (d.poppy@elsevier.com)

Ranbaxy Woes Continue With 30-plus Product Import Alert

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