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More Questions in FDA Delay on EC
Evidence of Potential White House Involvement in FDA Delay on Emergency Birth Control
WASHINGTON, DC — New evidence indicates that, in a highly unusual occurrence, a senior White House official met with the head of the FDA just days after an application was submitted to the FDA for over-the-counter status for emergency contraception (EC). In the three years since the application was submitted, serious questions have been raised about whether White House politics has interfered with scientific decision making at the FDA.
"The revelation today of a highly unusual consultation between the FDA and White House raises yet another red flag for those of us who care about science and provide health care services," Planned Parenthood Federation of America President Cecile Richards said. "The delay in making emergency contraception more available to women is inexcusable. Unfortunately, suspicious fingerprints have been found all over what should have been a purely scientific evaluation of a safe, effective back-up birth control option."
New York Newsday reported today that an April 21, 2003, calendar entry indicates that then-FDA commissioner Mark McClellan met with senior White House official Jay Lefkowitz to discuss Women's Capital Corporation's pending application for non-prescription availability of Plan B emergency contraception.
On December 16, 2003, a joint hearing of the FDA Nonprescription Drugs and Reproductive Health Drugs Advisory Committees voted 23 to 4 to recommend that the FDA make EC available over the counter. The FDA advisory panels concluded that EC meets all FDA requirements for over-the-counter status. However, on May 6, 2004, the FDA notified Plan B manufacturer Barr Laboratories that its application for the over-the counter status was denied. Recently, ACOG, the American College of Obstetricians and Gynecologists, denounced the FDA delay on expanding EC access and launched their own campaign to promote EC awareness to overcome government inaction.
Emergency contraception pills contain hormones that reduce the risk of pregnancy if started within 120 hours of unprotected intercourse. The sooner EC is administered after unprotected intercourse, the better it works, making timely access critically important.