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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