Reproductive-rights groups and women's health advocates say that a Food and Drug Administration decision to expand use of the so-called "morning after" pill not only thwarted a federal judge's ruling calling for unrestricted access, but also raised practical hurdles such as: Where will a 15-year-old get valid ID?
The U.S. Department of Justice on Wednesday said it intends to appeal an April federal district court order that would have made certain emergency contraception products available over the counter to all women without a prescription.
But the FDA on Tuesday lowered the age limit for Plan B One-Step emergency contraception, making it available without a prescription to girls as young as 15 and putting it on the shelves of stores with pharmacies instead of behind the counter.
In a letter requesting a stay of the order set to take effect May 5, justice department officials told U.S. District Court Judge Edward Korman that although the move wasn't intended to address his order, it has the "effect" of ensuring access to emergency contraception for even the youngest plaintiffs in the lawsuit.
But women's rights advocates said the decision also requires girls and women to show ID at the cash register and denies sale if they can’t produce it, noted Terry O’Neill, president of the National Organization for Women.
“Fifteen-year-olds don’t drive, so they won’t have state-issued identification,” she said. “It’s also anyone who looks 15 to the cashier. They will be carded at the cashier’s desk. That sets up the possibility of humiliation. You’re setting up humiliation for the most vulnerable population.”
Some girls that young could use learner's permits, which are available at age 15 in at least 30 states. State identification cards can take weeks to arrive.
FDA officials said a 15-year-old could use an alternative form of identification such as a birth certificate or a passport to buy the drug.
“If a 15-year-old is unable to verify their age, they will not be able to purchase Plan B One-Step,” said Stephanie Yao, an FDA spokeswoman.
The FDA’s approval of Plan B One-Step applies only to that product, which uses a single dose of levonorgestrel to prevent pregnancy when taken within 72 hours of unprotected intercourse. It does not apply to Plan B and other generic products that use two lower doses of the drug to stop pregnancy, or to ella, ulipristal, a prescription-only product.
Korman’s ruling would have applied to all emergency contraception that contains levonorgestrel.
In that order, Korman delivered scathing criticism of a 2011 decision by Health and Human Services Secretary Kathleen Sebelius that overruled recommendations by an FDA committee and Commissioner Margaret Hamburg to make Plan B available without age and point of sale restrictions. He wrote that the action was “politically motivated, scientifically unjustified and contrary to agency precedent.”
Sebelius was briefed on Teva’s Plan B One-Step application and review process before the FDA's approval and said that her concerns about access to the drug for very young girls were met, a Health and Human Services official told NBC News.
Speaking to reporters Wednesday after an appearance at a Latino Coalition forum, Sebelius affirmed the move: “The FDA made the decision and I support the decision,” she said.
But O’Neill said that vetting the process with Sebelius amounts to allowing politics to once again influence an issue that should be settled by science.
“Because she has already interfered once, my concern is that she might do it again,” she said.
Emergency contraception products use a high dose of hormones used for birth control to prevent or delay ovulation, prevent fertilization or, in some cases, prevent implantation of a fertilized egg. It does not end an existing pregnancy or harm a growing fetus, medical experts say.
Anti-abortion groups have consistently opposed emergency contraception because they believe it induces abortion, contrary to FDA claims. At the very least, they urged retention of the current law that requires prescriptions for Plan B for women younger than 17.
“The FDA is recklessly positioning itself as a parent to our children,” said Marjorie Dannenfelser, president of the Susan B. Anthony List, an anti-abortion group. “Fifteen-year-old girls need the protection that comes with the involvement of real parents and doctors in their lives. Expanded access to potentially dangerous, abortion-inducing drugs does not strengthen children or families.”
But one advocate for emergency contraception said the FDA’s decision to expand access to Plan B One-Step could be interpreted as a step forward. Dr. Cora Breuner, who wrote the American Academy of Pediatrics guidelines on emergency contraception, said she was torn by the current situation.
On one hand, doctors and scientists long ago confirmed that the drugs are safe and effective. On the other hand, expanding access to girls as young as 15, without a prescription and on store shelves is undeniably progress toward reducing unwanted pregnancies.
“It feels close, but not quite there,” she said. “Better, but not quite perfect.”
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