On December 10, 2008, U.S. Rep. Joe Barton, (Republican on the House Energy and Commerce Committee), wrote to the Food and Drug Commissioner, Andrew von Eschenbach, asking for information about the six month delay in the FDA’s seizure of contaminated lots of heparin from a manufacturer in Cincinnati, Ohio, Celsus Laboratories Inc.

In November, U.S. Marshalls seized 11 contaminated lots of the blood thinner heparin from Celsus after an April inspection found that the company wasn't properly recalling the product.

The text of the Barton letter states as follows:

The FDA’s management of the heparin issue continues to be of great interest to me and others on the Committee on Energy and Commerce. I commend you for your recent seizure of contaminated heparin from a manufacturer in Cincinnati, Ohio.

However, your November 6, 2008, announcement accompanying the enforcement action indicates that you twice previously informed the manufacturer (during an April 2008 inspection and again in a May 8, 2008, letter) that the company’s actions regarding the contaminated heparin were insufficient to assure an effective recall. I am concerned about this six-month delay between FDA informing the company of its insufficiencies and FDA taking enforcement action, and respectfully request your response to the following:

1. Why did FDA wait until November 2008 to seize the contaminated lots?

2. When was the recommendation to seize this contaminated heparin first made? Who made
it? Was it a written recommendation? Please provide supporting records as appropriate.

3. Please provide all FDA regulations, policies and/or guidances that govern the standards for authorizing this type of seizure.

4. Please list the names, titles, and offices of the FDA officials involved in the recommendation for the seizure of the contaminated heparin.

5. Please list the names, titles, and offices of the FDA officials involved in the decision on whether to approve the recommendation for seizure.

The letter than requested a response in the next four weeks. We will continue to keep you updated.

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