Pro-Life Women’s Group Doubts Veracity of GAO Report on Abortion Drug
by Steven Ertelt
LifeNews.com Editor
August 22, 2008
Washington, DC (LifeNews.com) — A leading pro-life women’s group is disputing the summary of a new Congressional report that concludes the Clinton administration did not rush through the approval of the dangerous abortion drug RU 486. Known as mifepristone, the abortion pill has killed seven women in the U.S. and 13 women worldwide.
In the waning days of the Clinton administration, pro-life advocates say FDA officials rushed through approval of the drug, which has injured thousands of women here.
The Government Accountability Office, a Congressional research firm, released a report earlier this week saying the drug was not given special treatment.
Responding to the rash of deaths in the U.S. after its approval, three pro-life Republican lawmakers asked the GAO to investigate the approval process. Its report says the FDA did not engage in any wrongdoing during it.
But Wendy Wright, the head of Concerned Women for America, says she thinks the report is off base and said she worries the GAO had a political agenda to protect those who approved the drug and support it now.
"It’s not too surprising that the government is whitewashing the government," she told OneNewsNow. "Sadly the GAO does have a history of being a bit political and leaning toward the liberal side."
Wright says her group examined the approval process and she contends the FDA did not "rely on accurate and adequate trials."
"[E]ven people within the FDA had expressed deep concern that the owners of RU-486 were not doing their due diligence, that they were not conducting the kinds of trials that the FDA requires of any other kind of drug," Wright said.
She said told OneNewsNow that one FDA scientist admitted data submitted to the agency by Danco Laboratories, which manufactures and distributes the drug, was "borderline fraudulent."
Wright says an independent panel should investigate the approval process.
In its report, GAO 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.
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.
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