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FDA Official Resigns over Contraceptive Delay

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Transcript

RENEE MONTAGNE, host:

This is MORNING EDITION from NPR News. I'm Renee Montagne.

The top women's health official at the Food and Drug Administration resigned yesterday. Susan Wood is protesting the FDA's failure to approve over-the-counter sales of the emergency contraceptive pill called Plan B. NPR's Julie Rovner has more.

JULIE ROVNER reporting:

For Susan Wood, an announcement last week by FDA Commissioner Lester Crawford was the last straw. Crawford said he would not decide yet whether to allow over-the-counter sales of the morning-after pill, Plan B. Wood said the action compromised her ability to do her job as head of the FDA's Office of Women's Health.

Ms. SUSAN WOOD (Former Head of FDA Office of Women's Health): This delay, which would last several years, in fact, is denying all women the appropriate access to this product, which is clearly safe and effective for its use.

ROVNER: The FDA's announcement last Friday was just the latest chapter in the two-and-a-half-year saga of the controversial drug. Plan B is two high doses of regular birth control pills which, when taken within 72 hours of unprotected intercourse, can avert most pregnancies. It is not the same as the abortion pill RU-486. In December of 2003, two FDA advisory committees voted overwhelmingly to allow over-the-counter sales of Plan B, and senior scientists at FDA agreed. But the agency said no, citing a lack of data about the effects of the drug on young teen-agers.

So Plan B manufacturer Barr Laboratories asked the FDA to let it sell only to women age 16 and over without a prescription. The FDA was supposed to decide by January, but it didn't. In the spring, when the Senate was considering Lester Crawford's nomination to head the FDA, two women senators held up the vote in order to force the decision. They allowed Crawford to be approved only after HHS Secretary Mike Leavitt promised a yes or no by September 1st. But FDA decided not to decide, and instead started a formal review process for Plan B. Susan Wood says that kind of review is much more than a brief delay.

Ms. WOOD: It's always a multiyear process. I've never seen it much shorter than that.

ROVNER: Wood says what's clear to her is that the decision was based not on science but on politics.

Ms. WOOD: The science is not driving decisions. The mission of the agency is not being fulfilled in the way it should be.

ROVNER: Women's health groups were quick to praise Wood's action. Karen Pearl is interim president of the Planned Parenthood Federation of America.

Ms. KAREN PEARL (Planned Parenthood Federation of America): She clearly is calling it for what it is, and recognizes that this is, in fact, a political, not a scientific or medical decision, and it often takes people who will take that kind of a risk and that kind of a stance to really shed the light that needs to be shed.

ROVNER: A written statement from the FDA praised Wood for her service and called her decision to leave `unfortunate.' But it's clear that FDA's latest actions are pleasing some of the president's allies in the anti-abortion community. Several anti-abortion groups say that if Plan B sometimes works by preventing implantation of a fertilized egg, that's abortion, not contraception. Jim Sedlak is vice president of the American Life League.

Mr. JIM SEDLAK (American Life League): They like to use the term `fertilized egg' to confuse people, but what they're saying is that fertilization takes place, a new human being is created and then that human being is prevented from implanting in the womb and therefore dies, and so this drug is causing the deaths of human beings in the womb.

ROVNER: For the next 60 days, the FDA will take comments from the public on Plan B. Meanwhile, some angry Democrats and Republicans in Congress are seeking explanations from FDA about its latest delay.

Julie Rovner, NPR News, Washington. Transcript provided by NPR, Copyright NPR.

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