House Energy and Commerce Committee leaders are pushing the Food and Drug Administration for answers about their actions in response to the contamination of heparin imported from China. In 2008, contaminated ingredients in the blood thinner led to severe illness and several deaths. Twelve million Americans are currently being treated with the drug.
"Three years ago, American citizens were exposed to lethally contaminated heparin. We know that this came from China and we've even identified where the tainted drugs probably came from," said Pitts. "Unfortunately, it doesn't look like FDA has been doing their best to prevent future contamination. That's why I joined with my colleagues to ask important questions about FDA's actions to prevent tainted drugs from entering the U.S."
The Committee has reason to believe that two Chinese firms involved in the contaminated drugs are still providing crude heparin to U.S. manufacturers. The letter to FDA Commissioner Margaret Hamburg asks the FDA why no warning letters or import alerts were sent to these firms. Also, the letter asks why FDA has not taken further action to alert U.S. heparin companies to avoid the firms implicated in the investigation.
"We are very concerned that FDA is not warning American companies away from the specific firms that may have produced tainted drugs," said Pitts. "We have evidence that other Chinese companies were given warning letters, but not the two most likely culprits. American suppliers also need to have all the information about these suppliers so that they can keep their products safe."