Barton wants answers from FDA about heparin scandal
December 17th, 2008 by Jennifer Walker-Journey
Rep. Joe Barton, a ranking member of the House Energy and Commerce Committee, appears to be fed up with the FDA’s reluctance to provide details of the tainted heparin scandal that first came into public light earlier this year, according to CNN Money. That scandal resulted in the deaths of more than 80 Americans and adverse reactions in hundreds more, and led to an agency recall of lots of the blood thinner manufactured in Baxter International’s Chinese facility.
Heparin from another company, APP Pharmaceuticals Inc., wasn’t considered a problem, though in a letter to Congress in October, the FDA said one patient taking the APP heparin had a severe reaction that may have led to his death, according to the news report. APP responded in a letter to the congressman’s staff that the company had thoroughly reviewed the case and did not believe the patient’s death was a result of contaminated heparin.
Rep. Barton wants to know why the FDA has “no information” about whether that patient’s death was caused by the same contaminant – over-sulfated chondroitin sulfate – as was found in Baxter International heparin.
Rep. Barton has been on the FDA’s case for more than a month, questioning the agency’s handling of the heparin recall, claiming it misrepresented deaths tied to the product , arguing that it didn’t thoroughly investigate the matter, and ordering answers on why the agency took six months to seize lots of contaminated heparin from an Ohio agency.