A Chinese facility that hasn't been inspected by the
U.S. Food and Drug Administration made the active ingredient in much of
the widely used Baxter International Inc.
blood-thinner that is under investigation after reports of hundreds of
allergic reactions and four deaths among the drug's users, the agency
The disclosure is likely to add to broad concerns
about the safety and quality of products imported from China and
elsewhere in the developing world. A tide of tainted goods ranging from
pet food to children's toys has prompted recalls and increased scrutiny
of Chinese-made wares around the world.
Although it isn't known whether the Chinese plant
played a part in the drug's problems, its role as a supplier to Baxter
is expected to fuel questions about U.S. regulators' ability to ensure
the safety and quality of imported drugs and drug ingredients.
On Monday, Baxter announced that it had temporarily
halted production of its version of the generic anticlotting drug
heparin because of about 350 bad reactions potentially tied to the
drug, including four fatalities, primarily in patients undergoing
kidney dialysis and heart surgery.
Yesterday, both Baxter and the FDA said it wasn't
clear that the ingredient from the Chinese supplier was tied to the bad
reactions. "We honestly don't know" the cause, an FDA spokeswoman said.
China is now the world's largest producer of active
pharmaceutical ingredients -- the chemical compounds needed to make
finished pills and other drugs. In 2005, China had $4.4 billion, or
14%, of the world's $31 billion market for active drug ingredients,
according to a report last year from Credit Suisse.
Recent testimony from the Government Accountability
Office said that the FDA may only inspect around 7% of foreign
drug-making facilities in a given year, and it would take the agency
more than 13 years at that rate to inspect all the plants. The
testimony also said the FDA "cannot provide the exact number of foreign
establishments that have never been inspected."
The agency also had varying counts of how many overseas facilities ship drug ingredients to the U.S.
"American lives will remain at risk until the FDA
commits the resources necessary to inspect imported drugs and drug
ingredients," said Bart Stupak, the Michigan Democrat who heads the
House Energy and Commerce Subcommittee on Oversight and Investigations,
in a statement yesterday.
The FDA said last night that it hadn't inspected the
Chinese facility that made the active ingredient in the Baxter drug.
"While no FDA inspection of the facility has been conducted to date,
preparations are being made to perform an inspection as soon as
possible. We have already requested expedited access to the facility,
facilitated through a recently signed agreement with the Chinese State
Food and Drug Administration. FDA also has requested the facility's
inspectional data and adverse event reports connected to the product,"
an agency spokeswoman said in an emailed statement.
The FDA spokeswoman said the plant making the active
ingredient "was supposed to be inspected" but "our understanding is
that, due to human error, and inadequate information technology
systems, a pre-approval inspection, which would normally be conducted,
was not." The spokeswoman couldn't immediately provide the name or
location of the Chinese supplier.
The agency has inspected a facility in Cherry Hill,
N.J., she said, where the finished version of the drug is packaged by a
A major competitor of Baxter's, APP Pharmaceuticals
Inc., of Schaumburg, Ill., also gets the active ingredient for much of
its heparin from a Chinese supplier. "We have not experienced" any
adverse reactions like those potentially connected to the Baxter drug,
a spokeswoman for APP said.
An FDA official estimated that around 40% of the
adverse reactions among patients taking the Baxter drug were classified
as serious. They ranged from stomach pain to vomiting and diarrhea, low
blood pressure, speeding heartbeats and fainting.
Heparin, which is derived from pig intestines, 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. Given either
intravenously or by injection, the drug is used in a wide range of
medical procedures to treat or prevent clotting.
In particular, the drug is essential during procedures
like cardiac surgery, in which a patient's blood is removed from the
body. It is also used in kidney dialysis and in apheresis, a procedure
used to treat some immune-system disorders, in which blood is taken
outside the patient's body and some components are removed.
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 and another in the U.S., 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. The company spokeswoman 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 acquired a unit of Wyeth that marketed the
drug, she said.
"There have not been changes" recently in the Chinese
operation, the Baxter spokeswoman said. She added, "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 existing supplies of
the drug, in order to avoid shortages. Officials of the FDA made that
decision along with executives of the Deerfield, Ill.-based company.
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.
--Nicholas Zamiska contributed to this article.
Write to Anna Wilde Mathews at firstname.lastname@example.org and Thomas M. Burton at email@example.com
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