Reps. Dingell, Stupak expand FDA inspection inquiry

Executive Summary

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)