RU486 Manufacturer
Cited for Violation of Federal Laws
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LA TIMES October 20, 2000
RU-486 Firm Linked to Drug
Impurities Investigation: Chinese company that produces abortion pill
for
U.S. market was cited for violation of federal laws, House committee
learns.
By AARON ZITNER, Times Staff Writer
WASHINGTON--The Chinese company producing the abortion pill RU-486
for the U.S. market has been cited by federal regulators for bringing
mislabeled and impure drugs into the United States, according to
congressional investigators.
This and other information, turned up by the House Commerce Committee
staff, suggest that the long battle over bringing RU-486 to American
women
may not have ended last month when the Food and Drug Administration
approved the drug for distribution. Critics of the abortion pill quickly
cited the
new information as evidence that the FDA did not conduct an adequate
review and that Congress should force the agency to reconsider.
But supporters of the abortion pill said there is no evidence that the
Chinese
plant is not meeting FDA standards in producing the abortion pill, known
formally as mifeprestone. The drug should reach U.S. doctors within a
few
weeks.
"As part of the approval process, the FDA had to review the
manufacturing
process and the manufacturer met the specifications of the FDA,"
said
Heather O'Neill, a spokeswoman for Danco Laboratories, the New York firm
marketing the drug in the United States.
Danco conducted a worldwide search for a manufacturer after large
pharmaceutical companies said that they did not want to produce the
drug,
fearing lawsuits and boycotts from anti-abortion groups. After a deal
with a
Hungarian plant fell through, Danco signed a contract with the
state-owned
Shanghai Hua Lian Pharmaceutical Co. Ltd., according to people familiar
with events.
According to FDA records cited by the House investigators, a drug
produced by Hua Lian was detained earlier this year by agency officials
in
Cincinnati because of false or misleading labeling. That drug,
betamethasone sodium phosphate, is sometimes used in skin creams and
asthma drugs.
Contamination Found in Herbal Remedy
Samples of another product, an herbal remedy called composite tegafuri
capsules, were found to be tainted in a 1998 study by the California
Department of Health Services. That study found high contamination in
hundreds of similar products made at the same plant.
The tegafuri was made by the Shanghai No. 12 Pharmacy Factory, which is
cited as the previous name for the Hua Lian factory on the company's Web
site. The product was found to be contaminated with fluorouracil, which
in
some forms is a chemotherapy drug.
Rep. Thomas J. Bliley (R-Va.), chairman of the House Commerce
Committee, wrote to the FDA on Wednesday asking whether the agency
knew that the Chinese plant had previously run afoul of U.S. regulators
and
whether that information was considered during the approval process for
the
abortion pill.
Irregularity Noted in Plant's Documents
In his letter, Bliley also cited the report of an FDA official who
inspected the
Shanghai plant in October 1999 in connection with the agency's review of
the pill. In that report, the FDA inspector said that the plant copied
data
from another application in filling out required paperwork, rather than
using
data from its own laboratory tests.
The plant passed a later FDA inspection in July. But in his letter to
the
FDA, Bliley asked whether the "discrepancies" during the first
inspection
suggested a wider "data integrity problem" at the plant.
The information turned up by Bliley's inspectors could become fodder for
lawmakers who want to create hurdles for the abortion pill in Congress.
Moreover, Texas Gov. George W. Bush, the Republican presidential
nominee, has said that he opposes distribution of the abortion pill and,
as
president, might look for any new evidence that the FDA should revisit
its
decision on use of the drug. Vice President Al Gore, the Democratic
nominee, supports distribution of the drug, if it meets FDA standards.
Douglas Johnson of the National Right to Life Committee, an
anti-abortion
group, called it "appalling" that the FDA approved production
of the drug "by
a Chinese plant that has been cited for producing both contaminated and
mislabeled drugs . . . and that falsified FDA documents."
"We conclude that the Clinton-Gore administration is willing to
place
American women in jeopardy in order to win short-term political points
from
pro-abortion special interest groups," Johnson said. Clinton, Gore
and the
FDA all have said that the FDA made its decision based on the safety of
the abortion pill, not on politics.
"As with all drugs the FDA approves, in the case of mifeprestone,
the FDA
thoroughly inspected its manufacturer and the facility passed," an
FDA
spokesman said. "It fully met the FDA's standards."
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