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Susan Wood says the Food and Drug Administration has been "hijacked."
Wood resigned from her post as the FDA's assistant commissioner for women's health and director of the office of women's health in August to protest the agency's delay in ruling whether emergency contraception, also referred to as the morning-after pill, should be sold over the counter.
Wood spoke Friday to about 400 people at the University of Washington.
"The FDA seems to have lost its independence and lost its ability to make decisions based on scientific and medical evidence," Wood said in an interview. Over-the-counter access could cut down on the number of unwanted pregnancies and abortions, Wood said.
Taken within 72 hours of unprotected intercourse, the morning-after pill -- essentially a high-dose birth-control pill -- is 89 percent effective in preventing pregnancy. But it's most effective within 24 hours.
In Washington, the pills are available without a doctor's prescription from some pharmacists.
Women's Capital Corp., the company that used to make the morning-after pill Plan B, first applied for over-the-counter sale in 2003.
Despite the recommendation of an FDA advisory committee and the agency's own scientific staff that the pills should be sold over the counter to women ages 17 and older, the FDA decided in August to solicit public comment on the issue.
The FDA is still reviewing those comments, said an agency spokeswoman.
Wood said she doesn't know who or what is influencing the decisions about the morning-after pill, but it's clearly coming from outside the agency.
"The normal processes were not allowed to go forward," Wood said. "All those people who had signed off on it, who normally make decisions at the FDA, were completely cut out.
"I don't have any real inkling as to where the decision was made," she said during a meeting this week with the Seattle P-I's editorial board.
A specialist in women's health policy, Wood started at the FDA in 2000. Before that, she worked at the Department of Health and Human Services and served as a science adviser to the Congressional Caucus for Women's Issues.
In a report issued in November, the independent Government Accountability Office concluded that the FDA's handling of the morning-after pill's over-the-counter status was "unusual."
The close involvement of high-level officials, the age restriction and the disregard of an advisory committee's recommendation contributed to the assessment, the report said.
Wendy Wright, president of Concerned Women for America, a conservative, religious women's advocacy organization, said gaps in knowledge about the drug's long-term effects and easier access for young teens have correctly slowed down the approval process.
"The FDA ... has no way of enforcing an age restriction," Wright said.
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