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Congressman John Dingell back in Charge

As you will see in a recent letter to the FDA by Congressman John Dingell, the FDA is being held up to severe scrutiny concerning the Ranbaxy Pharmaceutical situation. In the letter dated July 22, 2008, to the FDA Commissioner Dr. Von Eschenbach, Congressman Dingell wants to know what the FDA was doing when the problems at Ranbaxy were being discovered and why the FDA was not proceeding in protecting the public from possible adulterated products.

Congressman Dingell goes back to the generic drug scandal situation and asks the FDA Commissioner why he did not in an appropriate manner to get this drug off the market. The Congressman is now conducting an investigation on what occurred during the Pre-Approval Inspections of Ranbaxy and is requesting all the EIRs and other documentation prepared by the investigators as well as a list of the investigators who were involved in the inspections. He is going so far as having these investigators to appear in front of the Committee to answer questions.

We are not sure where this investigation is going or what the suspicions involving the FDA investigations and the investigators are but this is very, very rarely done. Maybe the Congress and the FDA should rethink the placement of FDA resident posts in foreign countries like China and India if the Congress and the FDA feels that there is any chance of inappropriate actions on the part of the investigators. Leaving FDA officials in a foreign country for an extended period of time could possibly lead to other potential problems. Is this the way to provide real consumer protection?

Click here to see a copy of the letter.

For more information on this please contact mdi at info@mdiconsultants.com.

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