Aug. 18 (Bloomberg) -- The abortion pill RU-486 wasn't given special treatment by U.S. regulators in its approval in 2000 or in its oversight since then, a government report found.

The pill, sold as Mifeprex by closely held Danco Laboratories LLC of New York, was approved and monitored by the Food and Drug Administration consistently with other products with restricted distribution, according to a report released today by the Government Accountability Office. More than 900,000 women in the U.S. have taken the drug.

Republican lawmakers opposed to abortion asked the GAO, the investigative arm of Congress, to review the FDA's approval and monitoring of Mifeprex. The FDA said in 2006 that the product wasn't shown to have caused six deaths from bacterial infections in women who had taken the drug. Critics have said Mifeprex was cleared with insufficient studies and regulators haven't done enough to assure its safety.

``The actions FDA has taken to oversee Mifeprex have been consistent with the actions it has taken to oversee the other Subpart H restricted drugs,'' whose distribution is limited to ensure safe use, the GAO said in its report to the lawmakers.

The GAO study was requested by Senators Michael Enzi of Wyoming and Jim DeMint of South Carolina and Representative Roscoe Bartlett of Maryland. Enzi's office is reviewing the report, spokesman Michael Mahaffey said. Bartlett's office also didn't immediately comment and a message left for DeMint wasn't immediately returned.

Accelerated Approval

Lawmakers and anti-abortion groups criticized the FDA for approving Mifeprex without comparisons to a placebo or similar treatments, using rules that give accelerated clearance to drugs for serious or life-threatening illnesses. Sales were limited to qualified doctors, not pharmacies, to end pregnancies within the first 49 days.

FDA's monitoring of Mifeprex safety has been similar to its handling of the eight other Subpart H drugs approved as of February 2007, the GAO said. The agency has reviewed its own inspections and information submitted by Danco, although at least one study promised by the manufacturer hasn't been completed, as is typical for most drugs, the report found.

The six deaths from infections occurred after one component of the two-part treatment was given in the vagina or by dissolving it inside the cheek, instead of the approved oral dosing, in an effort to reduce side effects such as nausea and vomiting. The FDA and Danco revised the prescribing information for Mifeprex and warned doctors and consumers about these safety concerns, the GAO said.

The GAO reported in 2005 that regulators gave an unusual review to an over-the-counter version of Barr Pharmaceuticals Inc.'s Plan B, also called ``the morning-after pill.'' Top officials at the FDA took an unusually active role in the drug's review and may have decided to reject Barr's initial application before government scientists weighed in, that report said.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

Last Updated: August 18, 2008 15:57 EDT