U.S. Reps question FDAs role in the 2008 heparin debacle

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Nearly two years after the heparin conundrum where the FDA linked 85 deaths and over 785 severe allergic reactions to tainted lots of the drug manufactured by Baxter International, policymakers have revealed “missteps” in what they call an unresolved investigation.

U.S. Reps. Joe Barton, R-Texas, and Michael Burgess, R-Texas, and members of the House Energy and Commerce Committee wrote a letter April 30 to FDA Commissioner Margaret A. Hamburg, MD, urging the agency's answers to formulated questions about the unrequited investigation.

The Reps., said that they have uncovered valuable information into the unresolved investigation of Chongqing Imperial, a Chinese pharmaceutical company, for its involvement and knowledge of the contaminated lots of heparin.

“The case, which remains unsolved, has been troubled since the problems first surfaced in 2008,” the letter stated.

“We are very troubled by how the FDA has handled the investigation to find out who was responsible for the contamination of heparin."

The committee accused the FDA for neglecting to follow-up on “specific and credible information” that it said linked Chinese heparin manufactures to the tainted drug at various supply chains.

Additionally, the committee said that while the FDA inspected Chinese heparin firms during 2008 and 2009, its inspections were not consistent or adequate.

Lastly, the committee accused the FDA of laxity during the investigation because the agency did not "adequately” follow-up with the Chinese government to link the proper source to the contaminated heparin.

The letter stated that “the staff [committee] has learned that the FDA has specific and credible information about certain Chinese heparin firms that warrants further investigation as suspect entities responsible for contaminating the heparin supply.”

Specifically, the committee said that various sources of information have raised concern about Chongqing Imperial, including misconstrued public information dealing with its web address, executive contacts and company shareholders who also may have involvement, but have gone unreviewed by FDA.

According to HuaiAn MDC Chemistry's website, Chongqing Imperial listed it as one of its two shareholders. 

“The question is raised whether the ownership interest could be used as a way for Chongqing Imperial to export some of HuaiAn’s crude heparin under a Chongqing Imperial label or a label of another Chinese heparin firm,” the letters stated.

The committee also has called into question Chinese export patterns during 2007 and 2008, where Chongqing Imperial was the third-ranking Chinese exporter of heparin.

To resolve the aforementioned issues and others, the committee outlined questions and asked Hamburg to provide the FDA's responses within four weeks of the dated letter.