Chinese Firm Tied to Tainted Drugs Identified as RU486 Manufacturer
Abortion Agenda Takes Priority Over
Women's Health, Safety

By Randall K. O'Bannon, Ph.D.
NRL Director of Education & Research

Despite government and abortion industry efforts to keep the identity of the manufacturer of RU486 a secret, on October 12 the Washington Post revealed that Hua Lian, a state-owned Chinese pharmaceutical firm operating on the outskirts of Shanghai, will be producing the RU486 that will be used to abort babies in the United States.

Though characterized as "among the tops in terms of production standards" compared to other Chinese manufacturers, congressional investigators have uncovered a number of incidents which cast doubt on the integrity of the Chinese company's production methods and how thorough and objective the Food and Drug Administration (FDA) was in inspecting and evaluating the facility.

The same firm, operating under a different name, is believed to have shipped contaminated capsules to the U.S. just a few years ago. In 1998, the California Health Department said there were " truly alarming levels of contaminants" in nearly half of the traditional Chinese medicines. The department listed "Compositae Tegafuri Capsulae" manufactured by Shanghai Pharmaceutical Factory #12 (Hua Lian's earlier designation) as one of the contaminated medications.

The FDA told staffers for the House Commerce Committee looking into the matter that the agency did not consider the firm's past record relevant to the safety of RU486. Committee chair Rep. Thomas Bliley (R-Va.), told the FDA in a November 1, 2000, letter, "I disagree."

Bliley wrote, "Possible false statements, the threat to public health posed by the shipment of contaminated medicines, and other violations of the Food, Drug, and Cosmetic Act is a pattern of conduct that reflects on the honesty and integrity of the management of Shanghai Hua Lian Pharmaceutical and thus its submissions to the FDA." Bliley added, "I do not believe the FDA's position is acceptable for a public health agency."

Rep. Bliley also noted in an earlier letter to the FDA (October 18, 2000) that as recently as July 17, 2000, a drug manufactured by the firm had been detained by the FDA's Cincinnati office for false or misleading labeling and misbranding. Bliley explained that the detention was never brought to the attention of FDA inspectors who inspected the Chinese plant in July 2000.

Addressing this issue in his November 1, 2000, letter, Bliley wrote, "Although FDA has asserted that the approval of mifepristone [RU486] was the result of adhering strictly to FDA's legal mandate and mission, such a claim is belied by the FDA's wilful ignorance about the full nature of Shanghai Hua Lian's conduct in the shipment of a falsely labeled, unapproved drug into the United States."

Bliley's staff also found evidence of serious improprieties in the documentation provided by the Hua Lian firm during the FDA's first mifepristone manufacturing inspection in October 1999. The FDA official conducting that inspection noted that while the Chinese firm's report on its chemical processes seemed generally accurate, "The information in the CMC [the Chemical and Manufacturing Controls report] that I reviewed didn't correspond to the methods and specifications used by the firm."

In his letter Bliley wrote that the interpreter explained to the inspector that Hua Lian had "copied information from the Roussel NDA [the New Drug Application of Roussel Uclaf, the French company that first developed and manufactured RU486] in a number of sections rather than translate their own methods from Chinese to English." The inspector reported that the interpreter also relayed information that the firm's consultant "told them that FDA wants all raw materials to meet USP1 specifications so they inserted numerous references to general USP chapters in the CMC which have nothing to do with the testing they perform."

The inspector indicated he "simply gave up" after waiting for four days for Hua Lian to translate the appropriate documents. Bliley noted, "As a result of this discrepancy and other deficiencies, the FDA withheld approval of the 1999 mifepristone submission."

Though the matter was apparently resolved to the FDA's satisfaction by the time of its July 2000 inspection, Bliley asked the FDA whether this was "suggestive of a data integrity problem." He added, "There is some reason to question whether the discrepancies were merely a result of the firm's inexperience with U.S. standards."

Bliley noted in his October 18, 2000, letter that the FDA again found several "deficiencies" in its July 2000 inspection but approved RU486 on the basis of promises of "corrective actions" by the firm.

NOTE:

1. USP - - the United States Pharmocopeia, a legally recognized compendium of standards for drugs.