Committee on Energy and Commerce, Republicans : Press Release :: Enforcement Delays in Heparin Case Prompt Inquiry by Barton to FDA

Enforcement Delays in Heparin Case Prompt Inquiry by Barton to FDA

December 10, 2008

WASHINGTON - U.S. Rep. Joe Barton, ranking Republican on the House Energy and Commerce Committee, today wrote to Food and Drug Commissioner Andrew von Eschenbach asking for information about the delay in FDA’s seizure of contaminated lots of heparin.

Barton expressed concern that FDA allowed six months to elapse from the time it began warning that recall efforts were falling short to the moment the agency stepped in and seized the bad heparin last month.

Heparin is a blood thinner that gained widespread notoriety earlier this year when authorities discovered that contaminated supplies from China might have contributed to the deaths of 81 patients in the United States. A recent report published in the New England Journal of Medicine blamed a man-made chemical that was evidently added to batches of the drug.

The text of the Barton letter follows:

December 10, 2008

The Honorable Andrew C. von Eschenbach, M.D.
Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

Dear Dr. von Eschenbach:

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.

Your response by four weeks from the date of this letter would be appreciated. If you have any questions, please have your staff contact Alan Slobodin of the Minority Committee staff at (202) 225-3641.

Sincerely,

Joe Barton
Ranking Member

cc: The Honorable John Dingell, Chairman
Committee on Energy and Commerce

The Honorable Frank Pallone
Chairman
Subcommittee on Health

The Honorable Nathan Deal
Ranking Member
Subcommittee on Health

The Honorable Bart Stupak
Chairman
Subcommittee on Oversight and Investigations

The Honorable John Shimkus
Ranking Member
Subcommittee on Oversight and Investigations

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