FDA Should Recall Drugs Subject To GMP Violations, Rep. Dingell Suggests
Executive Summary
The House Energy & Commerce Committee is suggesting that it is not enough for FDA to send a warning letter to a company in violation of good manufacturing practices
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From nuts to drugs
When the House Energy and Commerce Oversight Subcommittee turns its attention from salmonella-contaminated peanuts and inadequacies in the FDA system for monitoring food safety, CDER and Ranbaxy executives could be the next to feel the heat. Subcommittee Chairman Bart Stupak, D-Mich., already has an ongoing investigation into why FDA failed to remove Ranbaxy products from the market after it found GMP violations at a company plant in India in 2006 (1"The Pink Sheet," July 28, 2008, p. 27). A public review of findings from that inquiry would provide further impetus for action on the FDA Globalization Act introduced by Committee Chairman Emeritus John Dingell, D-Mich., with Stupak and Health Subcommittee Chair Frank Pallone, D-N.J. Action is needed "sooner rather than later to put the agency back on track in protecting the public from unsafe food and drugs," Stupak said Feb. 12 following a recall of all products made at the Peanut Corporation of America's Plainview, Tex., plant since its opening in 2005
From nuts to drugs
When the House Energy and Commerce Oversight Subcommittee turns its attention from salmonella-contaminated peanuts and inadequacies in the FDA system for monitoring food safety, CDER and Ranbaxy executives could be the next to feel the heat. Subcommittee Chairman Bart Stupak, D-Mich., already has an ongoing investigation into why FDA failed to remove Ranbaxy products from the market after it found GMP violations at a company plant in India in 2006 (1"The Pink Sheet," July 28, 2008, p. 27). A public review of findings from that inquiry would provide further impetus for action on the FDA Globalization Act introduced by Committee Chairman Emeritus John Dingell, D-Mich., with Stupak and Health Subcommittee Chair Frank Pallone, D-N.J. Action is needed "sooner rather than later to put the agency back on track in protecting the public from unsafe food and drugs," Stupak said Feb. 12 following a recall of all products made at the Peanut Corporation of America's Plainview, Tex., plant since its opening in 2005
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)