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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.


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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