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FDA Issues Another Heparin Warning, Faces More Backlash in Congress

May 12, 2008 | Parker Waichman Alonso LLP

Some medical facilities still have recalled heparin in their inventories, prompting the Food & Drug Administration (FDA) to issue yet another warning about the defective drug.  Meanwhile, the FDA is facing more criticism for not cooperating with a congressional investigation into the heparin debacle, with some lawmakers voicing frustration over the FDA's refusal to turn over a list of Chinese heparin suppliers to investigators.  Others are disturbed by the agency's inability to convince the Chinese to allow US inspectors access to all aspects of the country's heparin manufacturing system.

Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in a 12 countries.  In the US, other heparin suppliers have issued precautionary recalls, and some medical devices makers have also recalled heparin-coated products.

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs. Last month, FDA Commissioner Andrew von Eschenbach said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.”

Despite the publicity over tainted heparin, it appears some medical facilities haven't gotten the message and are still stocking recalled heparin.  Last week, the FDA issued an updated heparin warning in an attempt to make sure all medical providers are aware of the heparin recalls.   "Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS). Affected heparin products have been found in medical care facilities in one state since the recall announcement," the notice read. "Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used," it said.  

The FDA's reminder was prompted by reports from California Department of Health, the FDA's own recall monitoring, and from Baxter International Inc., the largest supplier of heparin, showing problems in the recall response. An FDA spokesperson told The Wall Street Journal that California authorities had sent a letter out on May 2 about gaps in the recall response.  Inspectors checked various facilities and found recalled heparin on crash carts, in catheter labs, and even on hospital pharmacy shelves.

Meanwhile, members of Congress have become increasingly impatient about the FDA's response to a congressional heparin investigation.  At this time, the FDA is refusing to give lawmakers access to the names of Chinese companies that supply heparin ingredients.  The FDA has said that doing so would violate privacy agreements concerning proprietary information.

Congress is also less than pleased with what appears to be Chinese attempts to block some facets of the heparin investigation.  Though it inspected the Changzhou facility in March, the FDA has been barred from having  complete access to some Chinese workshops that supplied Changzhou with raw heparin ingredients, as well as records and workers. The FDA was already under fire because, due to a compute error, it had never inspected Changzhou until the heparin contamination became an issue.  Since the March inspection, the agency has issued the factory a warning letter and barred it from importing products to the US.

But despite the Chinese reluctance to open up the entire heparin supply chain to FDA inspection, the agency is allowing heparin imports from that country's other manufacturers.  The FDA didn't issue a blanket "import alert" legally holding up all Chinese heparin pending successful testing, because it doesn't have the legal authority to do so, FDA officials have said.

Rep. Bart Stupak (D-Mich), the lawmaker leading the congressional investigation, told The Wall Street Journal the FDA should take a tougher stance with China.  If I was the FDA director, I'd shut down every drug coming in from China" until they were deemed safe, he said.