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The heparin story will be fodder for the US presidential campaign…

http://online.wsj.com/article/SB120293808086766253.html

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FDA Never Inspected Chinese Facility
Where Ingredient in Heparin Is Made

By ANNA WILDE MATHEWS and THOMAS M. BURTON
February 13, 2008 5:36 p.m.

A Chinese facility that has never been inspected by the U.S. Food and Drug Administration made the active ingredient of a Baxter International Inc. blood-thinner that is under investigation after reports of hundreds of allergic reactions and four deaths among its users, the agency said yesterday.

An FDA spokeswoman said the plant making the active ingredient for the drug heparin "was supposed to be inspected" but "due to human error, and inadequate information-technology systems, a pre-approval inspection, which would normally be conducted, was not." Currently, she said, "preparations are being made to perform an inspection as soon as possible."

The agency has inspected a facility in Cherry Hill, N.J., where the finished version of the drug was made, she said. The spokeswoman could not immediately provide the name or location of the supplier.

Both Baxter and the FDA said it wasn't clear that the product from the Chinese supplier is tied to the reactions, the cause of which has not yet been determined. "We honestly don't know" the cause, the agency spokeswoman said. An FDA official said earlier this week the reactions could even theoretically be tied to the product's packaging.

The role of a Chinese manufacturing facility in making the heparin is likely to immediately spark inquiries from Congress and consumer advocates. Lawmakers have already been investigating the safety of drugs imported from overseas, and a recent report from the Government Accountability Office said that few of the foreign factories are regularly inspected, though they make a large portion of ingredients for U.S. drugs.

The FDA disclosure comes on the heels of a series of safety problems involving Chinese made products.

On Monday, Baxter announced that it had temporarily suspended production of heparin because of about 350 reactions potentially tied to the drug, including four deaths, primarily in patients undergoing kidney dialysis and heart surgery. An FDA official estimated that around 40% of the adverse events potentially linked to the drug were classified as serious. Patients' reactions have ranged from stomach pain to vomiting and diarrhea, low blood pressure, speeding heartbeats and fainting.

Heparin is derived from pig intestines and has been sold in the U.S. since the 1930s. Baxter had been selling the product at a rate of about 100,000 vials a day. Heparin is given either intravenously or by injection and has a wide range of uses, from surgery to dialysis to treating clots, and is used to prevent clots after fractures.

A Baxter spokeswoman confirmed that the company gets the active pharmaceutical ingredient for its heparin from a U.S. supplier that operates a plant in China, but she declined to identify the supplier. She said that Baxter, in cooperation with the FDA, plans to inspect the Chinese factory, but she declined to say when. She said Baxter has been working with the U.S. supplier for 20 years, and the supplier has made the heparin ingredient for three decades.

Baxter has only sold heparin since late 2002, when it bought a unit of Wyeth, the spokeswoman said. "There have not been changes" in the Chinese operation, the spokeswoman said. She said "it's not a foregone conclusion" that the Chinese facility is connected to the problem.

Because heparin is widely used in hospitals and dialysis centers, Baxter didn't suspend sales of the heparin already produced. Officials of the FDA made that decision along with executives of Baxter, of Deerfield, Ill., to avoid shortages.

Baxter supplies about 50% of the heparin used in the U.S., so the possibility of a shortage arising is a real one. Although more than a week ago the company said it had concluded the reactions were confined to nine lots of heparin, it later found the adverse reactions had spread beyond those lots and to a wider range of dosages.
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