House Republicans blast FDA on handling of blood thinner probe

Republicans on the House Energy and Commerce Committee blasted the Food and Drug Administration on Friday, saying they were “very troubled” by the agency’s handling of its investigation into a contaminated blood thinner from China.

Texas Republicans Joe Barton and Michael Burgess, the ranking members on the panel and its oversight subcommittee, respectively, told Commissioner Margaret Hamburg in a letter that their own investigation found the FDA has not adequately followed up on “specific and credible” information linking Chinese heparin firms to counterfeit or contaminated heparin in several supply chains.

{mosads}The letter also said the FDA inspected several Chinese firms producing the blood thinner heparin in 2008 and 2009 but “did not conduct these inspections consistently and adequately for determining the source of the heparin contamination.”

And it charged that the FDA has “not adequately followed up” with the Chinese government about the investigation.

The Republicans’ investigation has been ongoing since the summer of 2008. 

Heparin, a blood thinner made from pig intestines, is widely used for kidney dialysis and surgery. Several dozen people died and several hundred fell ill in the United States in 2008 after heparin from China is believed to have been watered down with a shellfish-derived supplement to cut costs.

The FDA press office tells The Hill “Commissioner Hamburg has received the letter and will reply to Congressmen Barton and Burgess.”

The lawmakers’ letter gives Hamburg four weeks to answer seven questions relating to the investigation and what the agency is doing to get China to cooperate.

The letter says FDA has “specific and credible information about certain Chinese heparin firms that warrants further investigation as suspect entities responsible for contaminating the heparin supply.” The letter focuses mainly on one firm: Chongqing Imperial Bio-Chem. Co.

Coincidentally, the letter comes the same week as an initial public offering for heparin maker Shenzhen Hepalink Pharmaceutical made its two co-founders the richest people in China overnight, according to the Financial Times, underscoring the product’s economic importance. 

The Shenzhen firm is believed to be the only Chinese firm accredited by the FDA to export the active pharmaceutical ingredient heparin; the firms under suspicion in the 2008 case produced only crude heparin that was then processed, in China, by Wisconsin’s Scientific Protein Laboratories LLC for Deerfield, Ill.-based Baxter International.