FDA under fire for handling of heparin crisis

US Congressmen have accused the Food and Drug Administration (FDA) of not doing enough to investigate the contaminated heparin scandal which led to more than 200 deaths around the world in 2008.

In a letter to FDA Commissioner Margaret Hamburg, US Representatives Joe Barton and Michael Burgess claim that the agency "has not adequately followed up on specific and credible information linking Chinese heparin firms to counterfeit heparin or contaminated heparin."

They also ask for a response indicating the steps taken to uncover the perpetrators in the case within four weeks from the date of the letter, which is April 30.

The detailed letter claims that staff at the House of Representatives' Committee on Energy and Commerce has uncovered "specific and credible information" about the possible role of certain Chinese companies in supplying the contaminated heparin - including Chongqing Imperial Bio-Chem - that should be investigated further.

Chongqing provided crude heparin to USA-based Celsus Laboratories which used it to manufacture heparin active pharmaceutical ingredient (API) which was subsequently distributed to other manufacturers for further processing, it adds.

The Congressmen ask Hamburg to state how effectively the FDA can conduct a traceability investigation into the case on its own. i.e. without the assistance of the Chinese government and - if it does identify those responsible - what will it do with the information?