Plan B Ruling Reveals Glimpse Into Bush's FDA A New York district judge has ruled that Plan B must be made available to 17-year-olds without prescription. He says the FDA used politics, not science, to dictate its previous decision. The strongly worded decision provides an unusual glimpse into what went on behind the FDA's closed doors during its five-year deliberation on the drug.
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Plan B Ruling Reveals Glimpse Into Bush's FDA

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Plan B Ruling Reveals Glimpse Into Bush's FDA

Plan B Ruling Reveals Glimpse Into Bush's FDA

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  • <iframe src="" width="100%" height="290" frameborder="0" scrolling="no" title="NPR embedded audio player">
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A federal district court in New York has overturned one of the most contentious regulatory decisions of George W. Bush's presidency. That decision meant that women had to be 18 or older to access emergency contraception over the counter.

As NPR's Richard Knox reports, the court said the Food and Drug Administration based its policy on politics, not science.

RICHARD KNOX: Judge Edward Korman told the FDA that within 30 days, it must allow 17-year-old girls access to the so-called morning after pill without a prescription. And then he said the agency must reconsider its ruling that over-the-counter access to the pill should have age limits at all.

One of the youngest plaintiffs in the case is 15-year-old Angelica Jaffe of Brooklyn. She was happy about the decision.

Ms. ANGELICA JAFFE: It felt like a good thing, that people are actually listening to us, which was a good feeling.

KNOX: Judge Korman's decision was strongly worded. He said the FDA repeatedly and unreasonably delayed a decision on over-the-counter access to emergency contraception, and he agreed with the plaintiffs that the agency's decision was arbitrary and capricious.

Nancy Northup is president of the Center for Reproductive Rights, which represented five dozen medical and women's groups who brought the suit.

Ms. NANCY NORTHUP (President, Center for Reproductive Rights): The decision is a very clear indictment of the politics in women's reproductive health decisions during the Bush administration.

KNOX: It's unusual to get the kind of glimpse behind FDA's closed doors that Judge Korman's 46-page decision allows. The opinion quotes one staffer as saying, if this is not enough data upon which to base a decision, it's unclear what would constitute enough. It also quotes FDA staffers saying decisions were driven by the White House.

The ruling felt like vindication to Susan Wood. Four years ago, she resigned in protest as director of FDA's Office of Women's Health.

Dr. SUSAN WOOD (Former Director, FDA Office of Women's Health): This court decision is putting the responsibility back at FDA to do this again and this time, use the right process and respect what the evidence has to say, and reach a conclusion that's not been interfered with by the political leadership.

KNOX: Those who fought for years against over-the-counter sale of emergency contraceptive pills say they'll fight on as the FDA takes the issue up again.

Wendy Wright heads a group called Concerned Women for America.

Ms. WENDY WRIGHT (President, Concerned Women for America): The FDA should not be interfering with the parental oversight with minor girls, and that's, in fact, what this judge has determined it ought to be doing.

KNOX: Wright notes that the morning-after pill contains a higher hormone dose than regular contraceptives that require a prescription. She says the FDA has never done this before with an over-the-counter medication. She also said that emergency contraceptives have not lived up to the claims that their proponents made.

Ms. WRIGHT: What we do know is that since the morning-after pill has been easily available, there has not been a decrease in the number of unexpected pregnancies, and there is no evidence at this point that the number of abortions has gone down.

KNOX: Wright says one prominent researcher, James Trussell, has changed his earlier view that widespread use of the morning-after pill would reduce unintended pregnancies by half. Trussell heads Princeton University's Office of Population Research.

Mr. JAMES TRUSSELL (Director, Office of Population Research, Princeton University): I mean, I did believe that at one time, and I wish that it were true, but I do not believe that it's true.

KNOX: The latest evidence, Trussell says, is that many women still don't use the morning-after pill after unprotected sex, or don't use it consistently. But he's also happy about this week's court ruling. Trussell says the FDA's job is to determine whether a drug is safe and effective for individual women, not what its effect is going to be on society.

Richard Knox, NPR News.

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