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Summit News

FDA chief defends handling of heparin, Momenta

NEW YORK (Reuters) - The U.S. Food and Drug Administration had to act swiftly during a massive recall of the widely-used blood thinner heparin, but was not influenced by help from Momenta Pharmaceuticals Inc when it later approved one its drugs, the agency’s chief told Reuters.

FDA Commissioner Margaret Hamburg’s comments on Tuesday follows criticism from Republicans over the agency’s handling of the heparin contamination in 2008, which stemmed from ingredients from China.

At the time, 81 people died from contaminated versions of the drug while many others experienced serious allergic reactions. The FDA, in trying to nail down the source of the problem, relied on volunteer help from Momenta scientists.

The FDA later approved Momenta’s generic version of Sanofi-Aventis SA’s blood thinner Lovenox, but rivals such as Teva Pharmaceutical Industries Ltd have complained that their versions were not cleared as well.

A government report, released on Tuesday, questioned the FDA’s standards in accepting such outside help, saying the “risks could have affected the public’s confidence” in responding to the heparin crisis and also left it vulnerable in other ways.

Since then, the FDA has adopted policies that deal directly with concerns about working with outside experts, the Government Accountability Office said in its report.

Hamburg defended the FDA’s work with Momenta and the eventual approval.

“FDA really was able to separate in important ways the work done in addressing the adulterated heparin concern and the review” of Momenta’s drug, Hamburg said at the Reuters Health Summit in New York.

U.S. Representative Joe Barton, the top Republican member of the House Energy and Commerce Committee, said the findings point to major problems with the FDA’s ability to monitor the increasing number of products from other countries such as China.

“It’s now obvious that FDA has a fundamental weakness in how it deals with the surge of Chinese medical and food imports,” Barton said in a statement.

Reporting by Susan Heavey. Editing by Robert MacMillan

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