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GMP Storm Cloud: Generic Firms May Get Further Scrutiny After Actavis Recall

Executive Summary

The latest in a series of recalls for Actavis' Little Falls, N.J. facility comes at an awkward time for the generics industry and FDA, and could fuel a congressional push towards tighter oversight of pharmaceutical production

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Justice Department seeks manufacturing injunction against Actavis

Department of Justice files a complaint Nov. 13 on behalf of FDA seeking a permanent injunction to bar Actavis Totowa LLC and Actavis Inc. from the manufacturing and distribution of generic drug products until they demonstrate compliance with Good Manufacturing Practice requirements. The company says it "views the filing of this complaint as one step in a long regulatory process, and is fully committed to working collaboratively and openly with the FDA in a timely manner." The Totowa subsidiary has been in the spotlight for several years stemming from compliance issues (1"The Pink Sheet," Aug. 11, 2008, p. 24). Actavis initiated a class 1 recall for its Digitek tablets April 25 after an FDA inspection revealed manufacturing issues, and recalled all 65 drugs manufactured at its Little Falls, N.J., facility Aug. 1

Justice Department seeks manufacturing injunction against Actavis

Department of Justice files a complaint Nov. 13 on behalf of FDA seeking a permanent injunction to bar Actavis Totowa LLC and Actavis Inc. from the manufacturing and distribution of generic drug products until they demonstrate compliance with Good Manufacturing Practice requirements. The company says it "views the filing of this complaint as one step in a long regulatory process, and is fully committed to working collaboratively and openly with the FDA in a timely manner." The Totowa subsidiary has been in the spotlight for several years stemming from compliance issues (1"The Pink Sheet," Aug. 11, 2008, p. 24). Actavis initiated a class 1 recall for its Digitek tablets April 25 after an FDA inspection revealed manufacturing issues, and recalled all 65 drugs manufactured at its Little Falls, N.J., facility Aug. 1

Reps. Dingell, Stupak expand FDA inspection inquiry

With the expansion of the Energy and Commerce Committee's two-year inquiry into FDA's alleged manufacturer inspection failures, pharma can assume that any GMP violations will lead to questions of their core bioequivalence verification methods. Rep. John Dingell and fellow Michigan Democrat Rep. Bart Stupak sent a letter to Commissioner Andrew von Eschenbach Oct. 8 regarding Actavis Totowa's Aug. 1 recall of all drugs manufactured at the Little Falls, N.J. plant (1"The Pink Sheet," Aug. 11, 2008, p. 24). The letter requests a number of FDA documents, including a list of laboratories performing BE studies for Actavis products and FDA personnel responsible for inspecting those labs. The inquiry comes on the heels of an ongoing investigation into allegations of fraud related to Ranbaxy bioequivalence and stability data in its ANDAs (2"The Pink Sheet," July 28, 2008, p. 27)

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