US Report: Over 900,000 Doses RU-486 Have Been Prescribed

FDA did not Err in Fast-Tracking RU-486 Abortion Pill Approval
Wed Aug 27, 2008 - 12:15 pm EST

By Hilary White

  WASHINGTON, DC, August 27, 2008 ( - The U.S. Government Accountability Office (GAO) has concluded that the Food and Drug Administration (FDA) followed all the correct procedures when it approved the abortion drug RU-486, sold in the US as Mifeprex, in September 2000.

  Since then, the report notes, the drug has been prescribed at least 900,000 times.

  The report says that the FDA has also not erred in its subsequent handling of the abortion drug, despite the deaths of several women who used it. The GAO is not an independent non-government body, but is known as "the investigative arm of Congress" and "the congressional watchdog."

  The report was conducted after critics, including many in the pro-life movement, had said that Mifeprex was fast-tracked for approval under the FDA’s rules, "Subpart H", that are normally meant to be applied to drugs that treat serious or life-threatening illnesses. The GAO also said that "concerns" had been raised about FDA’s oversight of the drug since approval in the light of the deaths of several women in the U.S. who had taken the drug.

  In its final review of Mifeprex, the FDA had concluded that "termination of unwanted pregnancy" falls under the category of a "serious condition" that justified following procedures and imposing restrictions under Subpart H.

  The report said that Mifeprex "was approved and monitored by the Food and Drug Administration consistently with other products with restricted distribution".

  The "FDA investigated the deaths of six U.S. women who developed a severe infection after taking the drug and concluded that the evidence did not establish a causal relationship between Mifeprex and the infections. Finally, FDA has taken similar actions to address emerging safety concerns across the drugs, such as changing labelling."

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