FDA Withholds List of Chinese
Heparin Suppliers From Probe
By ALICIA MUNDY
May 10, 2008; Page A4
WASHINGTON -- The Food and Drug Administration is withholding a list of Chinese heparin suppliers requested by congressional investigators looking into problems with tainted supplies of the blood thinner, saying confidentiality agreements prevent release of the companies' names.
Members of Congress also are concerned that Chinese heparin manufacturers and their raw-material suppliers didn't fully cooperate with an FDA inspection team in February, after the heparin crisis erupted internationally, and barred the FDA from complete access to some workshops, records and workers.
An FDA compliance official testified to a congressional subcommittee April 29 that the FDA could try to revisit facilities in China, but said, "I cannot say whether they will admit us or not, or whether they will allow us to do a full inspection."
Tensions between congressional Democrats and the FDA over the agency's handling of the heparin problem and its willingness to disclose information have escalated in recent weeks.
"The FDA thinks they have it under control, but they really don't," said the congressman leading the investigation, Rep. Bart Stupak (D., Mich.). The FDA's reluctance to release the Chinese companies' names is a red flag, he said. "If I was the FDA director, I'd shut down every drug coming in from China" until they were deemed safe, he said.
A spokeswoman for the FDA said the agency is looking at finding a way to give the committee the information it requested 10 days ago without violating confidentiality agreements involving proprietary information.
Mr. Stupak's House subcommittee is investigating the circumstances surrounding at least 81 deaths in the U.S. linked to tainted heparin derived from Chinese raw materials. The FDA has said it doesn't yet know how or when the contaminated ingredient, oversulfated chondroitin sulfate, was put into the supply. Agency officials have indicated that it was likely a deliberate act, possibly to stretch the supply of a profitable export.
Most of the reported problems have involved Heparin USP, given in large doses intravenously during heart surgery and kidney dialysis to prevent clotting.
In February, FDA inspectors were allowed to inspect the Changzhou SPL plant that made the main heparin ingredient for Baxter International Inc., then the largest U.S. maker of Heparin USP.
A spokeswoman for Baxter said the company "is seeking access further down the supply chain to the Chinese facilities" that feed the plant.
But in recent testimony, an FDA inspector said Chinese manufacturers barred them from complete access to two of Changzhou SPL's consolidators of crude heparin supplies. Changzhou SPL is majority owned by Scientific Protein Laboratories Inc., of Wisconsin. A spokeswoman for Baxter, Erin Gardiner, said the company also "is seeking access further down the supply chain to the Chinese facilities" that feed Changzhou SPL.
The Chinese government, meanwhile, has insisted that its products didn't cause American deaths and said this week that Baxter wasn't cooperating in China's investigation. Ms. Gardiner said, "We disagree. We hosted the Chinese in April at our plant in New Jersey and have agreed to provide them with heparin samples."
The FDA is relying on voluntary testing agreements with some companies to check their heparin ingredients for contamination before they distribute their supplies in the U.S., said a spokeswoman for the FDA, citing congressional testimony by FDA officials.
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.
The tainted-heparin scare has become one of several cases congressional Democrats have used to criticize the Bush administration.
Janet Woodcock, the FDA's drug-safety director, has said that FDA actions involving the Chinese imports are limited by a Memorandum of Agreement with China. That memorandum helped speed the entry of the FDA to China and helped open lines of communication with Chinese regulators, an FDA official testified. But Mr. Stupak called the memorandum "useless," adding, "I can go to the plant there [China] and look at the paint on the walls, but not be allowed to inspect the lab."
--Thomas M. Burton contributed to this article
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