FDA Failed to Follow Credible Leads Involving Contaminated Heparin: Report

Two U.S. lawmakers say that FDA investigators failed to properly follow up on the source of contaminated heparin that caused severe allergic-type reactions in hundreds of people in late 2007 and early 2008, and which was linked to the death of 81 people in the United States. 

Representatives Joe Barton and Michael C. Burgess wrote a letter (pdf) to FDA Commissioner Margaret A. Hamburg on April 30, saying that it appeared the agency dropped the ball on investigating credible leads while attempting to determine who contaminated the blood thinner with over-sulfated chondroitin sulfate.

The contaminated heparin, which was made from counterfeit ingredients imported from China, resulted in a heparin recall that impacted about half of the blood thinner supply in the United States.

The lawmakers say that the FDA failed to follow up on specific and credible information that linked Chinese heparin firms to contaminated supplies. They also said that the FDA failed to consistently and adequately inspect Chinese heparin firms for compliance and has not adequately followed up on the contamination investigation with the Chinese government.

“We are very troubled by how FDA has handled the investigation to find out who was responsible for the contamination of heparin,” the congressmen state in their letter.

A Baxter heparin recall was issued in January 2008 after a spike in adverse event reports surfaced involving reactions to heparin, an anticoagulant or blood thinner that is critical for a number of medical procedures and conditions. At that time, Baxter manufactured about half of the injectable heparin sold in the United States and it was discovered that the crude heparin used to make the drug contained a fake ingredient received from a plant in China that was chemically similar to heparin, yet substantially cheaper.

The lawmakers raise questions about the FDA’s investigation of Chongqing Imperial, a Chinese firm that manufactured some of the heparin. The congressmen say that there is evidence Chongqing deceived the FDA about its role in the heparin supply chain, which could have been uncovered if FDA had investigated more thoroughly. 

However, Barton and Burgess also say that the Chinese government appears to have hindered and stonewalled FDA investigators, making their job difficult, if not impossible, in some cases. The letter asks whether it would not have been better to call in the World Health Organization (WHO), since the contamination constituted an international health problem. The letter also calls on the FDA to continue pushing for answers.

Dozens of heparin recall lawsuits are currently consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, in the U.S. District Court for the Northern District of Ohio, and more lawsuits over the contaminated heparin are expected. All of the cases involve similar allegations that tainted lots of heparin distributed by Baxter Healthcare caused severe and potentially life-threatening allergic-type reactions. The first Baxter heparin trials in the MDL are scheduled to begin in November 2010.