Govt Report Claims Clinton Administration Approved Abortion Drug Properly

National   |   Steven Ertelt   |   Jan 1, 2009   |   9:00AM   |   WASHINGTON, DC

Govt Report Claims Clinton Administration Approved Abortion Drug Properly

by Steven Ertelt Editor
August 18
, 2008

Washington, DC ( — In the waning days of the Clinton administration, pro-life advocates say FDA officials rushed through approval of the dangerous abortion drug RU 486. A new report claims the agency did not rush the drug through the approval process, even though it has resulted in the deaths of at least 13 women worldwide.

The Government Accountability Office released a report today claiming the drug, also known as mifepristone, was not given special treatment.

The abortion pill has come under fire for causing the death of women across the globe, including the most recent death of a British teenager, and injuring more than 1,100 women in the United States alone.

Responding to those deaths and injuries, three pro-life Republican lawmakers asked the GAO, the research arm of Congress, to investigate the approval process. Its report says the FDA did not engage in any wrongdoing during it.

"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,” it said.

Yet, the report also noted problems in the follow-up to the approval of the drug.

The abortion drug was approved on the condition that its distributor, Danco Laboratories, conduct two post-approval studies on the complications and problems resulting from using the drug. GAO indicates Danco has only submitted one such study in the eight years since the drug was approved.

"FDA has cited the sponsors of seven of the drugs [approved in the special Subpart H process], including Mifeprex, for adverse event reporting deficiencies," GAO indicated.

The GAO report also included some criticism of FDA officials for not being as thorough as they could with reporting of complications.

"For example, the sponsor of Mifeprex agreed to provide 15-day alert reports for cases of serious infection and ruptured ectopic pregnancy in women who used the drug," it said. "FDA officials told us that staff review all submitted reports, but do not always document their reviews."

More follow-up is needed as three FDA inspections resulted in citations.

"As a result of the Mifeprex inspections, FDA issued citations for deficiencies related to the accuracy, completeness, or timeliness of some reports as well as for the sponsor’s failure to follow certain procedures for handling some adverse event follow-up activities," GAO indicated.

The report indicated that the FDA numbers show seven women who died using the RU 486 abortion drug, including six who developed deadly infections and a seventh who had an undiagnosed ectopic pregnancy.

"In her testimony to Congress on May 17, 2006, Dr. Janet Woodcock discussed three other cases of deaths in U.S. women who had taken Mifeprex that, following investigation, were determined unlikely to be related to the use of the drug," the report added.

Senators Michael Enzi of Wyoming and Jim DeMint of South Carolina as well as Representative Roscoe Bartlett of Maryland requested the GAO report.


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