Plan B Interference?

Attorney for the women's rights group challenging feds' refusal to allow over-the-counter sale of emergency contraceptives says she has proof that Bush administration meddled in FDA drug-approval process

As a legal challenge to the feds' refusal to allow over-the-counter sales of emergency contraceptives continues to unfold in federal court in Brooklyn, an attorney for the women's rights group bringing the challenge told the court that she now has proof that the Bush administration meddled in the U.S. Food and Drug Administration drug-approval process.

The New York City-based Center for Reproductive Rights is asking the federal court to force the FDA to approve over-the-counter sales of so-called Plan B, the emergency contraceptive used to prevent an unwanted pregnancy after incidents of unprotected sex. The drug contains nothing more than an elevated dose of the hormones contained in regular birth control pills; nonetheless, former FDA administrator Mark McClellan denied the bid to allow over-the-counter sales. In so doing, he overrode the recommendation of FDA scientists and other officials who had approved the move – causing two FDA officials to resign in protest.

Women's reproductive rights advocates have long suspected the White House may have had a hand in prompting McClellan's baseless refusal, and last week CRR attorney Bonnie Jones told federal Magistrate Viktor Pohorelsky that she may have found that missing link, in the form of an entry in McClellan's appointment calendar, reports New York's Newsday. According to the daily, McClellan's calendar for April 21, 2003 contains a notation that he had a "conference call w/Jay Lefkwitz re: Plan B submis" – an apparent reference to the petition filed just days before seeking FDA approval for over-the-counter Plan B sales. At the time, Lefkowitz served as President George W. Bush's deputy assistant for domestic policy; the calendar notation was notable, at least in part, because consultations with the White House are not part of the standard FDA drug approval process, the daily reports.

The news sparked angry responses from women's health advocates who consider the calendar entry a smoking gun. "The revelation … 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," said Cecile Richards, president of Planned Parenthood Federation of America, in a press release. "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."

The CCR's in-court challenge to the FDA refusal continues this week; McClellan is reportedly scheduled to testify on June 13.

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Planned Parenthood, Food and Drug Administration, FDA, Mark McClellan, Bonnie Jones, Plan B, emergency contraceptives, Cecile Richards, reproductive rights, reproductive health, Viktor Pohorelsky, Jay Lefkowitz, Center for Reproductive Rights

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