Congress criticises FDA over contaminated heparin case
pharmafile | May 6, 2010 | News story | Manufacturing and Production |Â Â heparin, manufacturing complianceÂ
The US Food and Drug Administration’s follow-up of the contaminated heparin scandal which surfaced in 2008 has been inadequate, according to a letter sent to the agency by two US Congressmen.
US Representatives Joe Barton and Michael Burgess, both Texas Republicans and on the House Energy and Commerce Committee, claim in the letter that the FDA has failed to act on “specific and credible information” linking Chinese companies to contaminated and counterfeit heparin.
More than 200 people died from allergic-type reactions when exposed to heparin contaminated – apparently deliberately – with oversulphated chondroitin sulphate (OSCS) which was not detected by standard impurity testing. The material found its way into heparin products in at least 10 countries around the world and led to widespread product recalls.
In the letter to FDA Commissioner Margaret Hamburg, Barton and Burgess say they are “troubled by how FDA has handled the investigation to find out who was responsible for the contamination of heparin”.
A review of FDA correspondence by Committee staff has revealed that the agency had information pointing to the involvement of at least one Chinese company – Chongqing Imperial Bio-Chem Co – in the case, they say.
However, the FDA “has not adequately followed up with the Chinese government about the heparin contamination-source investigation, despite questions being raised about Chongqing’s role by overseas regulatory bodies, FDA’s own inspections records and publicly-available information on the company’s operations”.
The Congressmen pose a number of questions to Hamburg, including asking for a detailed account of the FDA’s strategy and those responsible for handling the investigation, as well as a statement on what actions will be taken if the case is solved.
They also ask to what extent the FDA can conduct a traceability investigation without the aid of the Chinese authorities, and whether it can collaborate with China under current law.
The letter asks for a response from the FDA within four weeks of the letter’s April 30 date.
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