RU-486: Conservative Group Whispers Made In China

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ru486.jpgJudicial Watch, which bills itself as a conservative public interest group that “advocates high standards of ethics and morality in our nation’s public life,” has been battling acceptance of the abortion pill, which is known as Mifeprex or Mifepristone, for years. Now, the group has obtained documents from the FDA indicating the pill was made in China at the time the agency approved its use in 2000.

Why might anyone care? Well, as you may recall, there’s a great deal of concern these days over manufacturing standards in China. FDA commish Andy von Eschenbach was there just last week talking to his counterparts about making improvements. The issue is so sensitive that AstraZeneca recently tried to downplay its long-term plans to outsource many activities, including making active pharmaceutical ingredients, in China.

As Judicial Watch notes, the FDA tagged the Chinese manufacturer of RU-486 in 1999 and 2000 for manufacturing deficiencies. (Here are the documents, which the group obtained as part of its litigation with the FDA). The company that sells the pill in the US, Danco Laboratories, has never acknowledged where RU-486 is made, citing security concerns.

A Danco spokeswoman didn’t address the question in an e-mail sent us today. “The FDA approved Mifeprex following its usual rigorous and extensive review because it met the legal and scientific standards for approval,” she wrote us, “and that the drug continues to meet these standards.”

As a result, we don’t know whether RU-486 is made in China. An attorney for Judicial Watch says the group was ‘careful’ to word its statements so that it’s not accused of suggesting the pill is currently manufactured in China. Nonetheless, the group is clearly trying to create still more controversy, beyond any ongoing moral debate. Depending upon any reaction to this gambit, Danco may be put on the defensive once again.

In its statement, Judicial Watch also cites the documents to allege that the FDA was aware of, and “knowingly participated” in, off-label use of another drug, Cytotec, in connection with RU-486. The group also charges that two researchers who conducted RU-486 clinical trials held conflicts of interest because of their associations with organizations that actively worked to gain FDA approval and public acceptance of the pill.

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