Women's health advocates were quick to cry foul Wednesday when Health and Human Services Secretary Kathleen Sebelius overruled the opinion of the Food and Drug Administration that the popular "morning after" emergency contraceptive "Plan B One Step" should be allowed to be sold without a prescription — and without age restrictions.
"As doctors and researchers have repeatedly stated, ample research shows Plan B to be safe for women of all ages and appropriate for over-the-counter access. It is deeply disappointing that this administration would repeat the mistakes of the previous one," said Susan Wood, an associate professor at George Washington University's School of Public Health. Wood was an assistant commissioner for women's health at the FDA but quit in 2005 over its continued delay on over-the-counter approval for Plan B.
The result of Sebelius' action is that Plan B will remain available to women ages 17 and older without a prescription, but those 16 and younger will still need to see a doctor first in order to get the product.
That split approval means, in fact, that even older women will still face barriers to obtaining the contraceptive.
No matter how old you are, "having to go in, show your ID, talk to someone you've never met before and say 'I need Plan B' can be embarrassing," says Atsuko Koyama, a pediatrician and emergency room doctor at Boston Medical Center and a board member of the group Physicians for Reproductive Choice and Health.
If the age restrictions are removed, Koyama said, "just going to the drug store and buying the Plan B along with your birthday cards and your other sundry items [would] help increase the access and decrease the number of unintended pregnancies."
In her letter rejecting the FDA's recommendation, Sebelius noted that if all age restrictions were removed, "the product would be available, without a prescription or other point-of-sale restrictions, even to the youngest girls of reproductive age" and questioned whether the company, Teva Pharmaceuticals, provided enough data to show those girls would have the ability to use the product correctly.
But Wood said that sets a double standard.
"They don't do this for pain medication, headache medication, cold medication," she said. "That's not part of how we assess products. Are we going to go and now do this with all products, or are contraceptives once again being singled out for this special treatment and this extra standard when we're talking about a very safe and very effective product that can really help women?"
Wood and others said Sebelius' action reminded them of how the Bush administration treated the issue.
"For me personally this is an incredibly disappointing moment," said Kirsten Moore, president of the Reproductive Health Care Technologies Project. "Because I was in the East Room of the White House in March 2009 when [President Obama] signed an executive order saying this administration was committed to restoring scientific integrity to the policymaking process. And that commitment just went up in smoke today."
But not everyone is unhappy with the decision.
"I think that most reasonable people will agree that a young girl who's sexually active — seeing a medical professional is a positive thing," said Jeanne Monahan of the conservative group the Family Research Council.
Lifting the age restrictions, she said, "we think is not in the best interest of young women's health."
Meanwhile, the Obama administration is facing yet another contraception-related decision: whether to back away from new rules requiring most religious employers to include contraception in their health insurance plans. Catholic leaders have already met personally with Obama to lobby for the change.
That, says Moore, coupled with this latest decision, is not a good sign. "When there's political pushback, they back down," she said of the administration.
A decision on the contraceptive rules is expected any day.
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STEVE INSKEEP, HOST:
Health and Human Services Secretary Kathleen Sebelius has overruled the scientific opinion of the Food and Drug Administration on a morning after contraceptive pill. It had been deemed safe enough to be sold without a prescription and without any age restrictions. But yesterday's ruling means teens 16 and younger will still need a prescription. NPR's Julie Rovner reports on a political debate stretching back years.
JULIE ROVNER, BYLINE: In 2003, two FDA advisory committees voted overwhelmingly to make the morning after contraceptive bill, known as Plan B, available over the counter to women of all ages.
DR. ATSUKO KOYAMA: It's always been known to be quite safe. There are no contraindications for its use at all. If someone is already pregnant, it does not cause an abortion.
ROVNER: Atsuko Koyama is a pediatrician and emergency room doctor at the Boston Medical Center. She says the teenagers she sees in her ER are quite capable of knowing what to do with the medication.
KOYAMA: I have had patients who are 15, 16 years old, who come into the ER asking for Plan B, so, you know, they're taking responsibility for their health and their future.
ROVNER: But the FDA didn't follow its advisors' recommendations back then, which was unusual. Many women's health groups and members of Congress charged that the Bush administration's decision was politically motivated. Susan Wood, the FDA's assistant commissioner for women's health, ended up quitting her job in disgust.
SUSAN WOOD: That was part of a series of blockages that occurred, which clearly was showing FDA being overruled and not being allowed to do its job and make its decisions based on their interest in the public health and in women's health.
ROVNER: Finally, in 2006, the FDA decided to make the pill available without a prescription to those 18 and over, but still require younger teens to see a doctor first. A judge later lowered to 17 the age at which a prescription would not be necessary. But the impact of that split approval means that the product isn't really available over the counter, even for adults, Wood says, because they still have to ask for it and show ID. And with this latest decision, that won't change.
WOOD: For all women of all ages who are in an urgent situation, they still have to go find an open pharmacy and ask permission of the pharmacist or the pharmacy clerk to have access to this product.
ROVNER: It was that hope of making emergency contraception much easier to get that has outraged, not just people like Susan Wood, but women's health advocates like Kirsten Moore. She's president of the Reproductive Health Technologies Project.
KIRSTEN MOORE: I was in the East Room of the White House in March 2009 when the president signed an executive order saying this administration was committed to restoring scientific integrity to the policymaking process. And that commitment just went up in smoke today.
ROVNER: Not everyone is unhappy, however. Conservative groups have long favored keeping the age restrictions in place. Jeannie Monahan is with the Family Research Council.
JEANNIE MONAHAN: So I think that most reasonable people will agree that a young girl who's sexually active, seeing a medical professional is a positive thing.
ROVNER: No one can remember a case before of an HHS secretary stepping in to overrule a scientific opinion made by FDA. And now the administration is facing yet another contraception related-decision, whether to back away from new rules requiring most religious employers to include contraception in their health insurance plans. Catholic leaders have already met personally with President Obama to lobby for the change. Kirsten Moore says she's no longer confident the administration will fight for its own rules.
MOORE: When there's political pushback, they back down.
ROVNER: The decision on the contraceptive rules is expected any day.
Julie Rovner, NPR News, Washington.
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