Congressional Report Suggests FDA Bias on Morning After Pill

National   |   Steven Ertelt   |   Nov 14, 2005   |   9:00AM   |   WASHINGTON, DC

Congressional Report Suggests FDA Bias on Morning After Pill Email this article
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by Steven Ertelt Editor
November 14, 2005

Washington, DC ( — A new Congressional report suggests the Food and Drug Administration played politics with the decision on whether to approve the morning after drug to be sold over the counter to women over the age of 16. The agency continues to postpone a final decision saying it needs more information.

But Congressional auditors at the General Accounting office, conducing a study on behalf of pro-abortion lawmakers, say the FDA hasn’t reviewed all of the scientific data it already has.

Those who favor the Plan B drugs, which can cause an abortion on occasion, say their charges that the FDA played politics with the drug are confirmed.

Rep. Henry Waxman, a California Democrat, said he and other pro-morning after pill lawmakers "are deeply opposed to this subversion of science."

"It appears that the decision … was preordained from the outset," he and 17 other lawmakers claimed in a letter to Health and Human Services Secretary Mike Leavitt on Monday.

The members of Congress want to know from Leavitt whether the agency destroyed documents from the office of former FDA commissioner Mark McClellan that could have shed more light on the decision-making process.

In a statement responding to the GAO report, the FDA said the Congressional agency "mischaracterizes facts."

"We question the integrity of the investigative process that results in such partial conclusions," the agency said.

Concerned Women for America, a leading pro-life group, commended the FDA and said the agency was properly proceeding with caution and concern for women’s health when evaluating the drug for over the counter status.

"Barr Labs never bothered to adequately research whether it could be taken safely by the full population who would purchase it from drugstore shelves," CWA vice president Wendy Wright said of the company seeking OTC approval.

"Thankfully, the FDA’s leadership did what others refused to do — consider whether a drug’s easy availability would present unique health risks to women and girls," Wright said.

Wright testified at the FDA Advisory Committee hearing on OTC for Plan B. CWA also filed an extensive report earlier this month with the FDA, which argued that it lacks the authority to approve Plan B with an age restriction and that OTC status for Plan B would put women at medical risk.

"Making Plan B over-the-counter would needlessly expose adolescents to risks and reduce access to health care to those in need of it," Wright added.

Related web sites:
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