June 11, 2013 at 12:21 PM ET
The Obama administration may have backed down after a decade of fighting over emergency contraception, but don’t expect to see Plan B, or any other morning-after birth control product, out from behind the counter anytime soon.
For one thing, the federal government has come back to the judge handling the case with an offer that he may or may not approve. For another, it will take the company that makes the product a while to re-apply to for approval and re-package the pills in a way appropriate for selling out in the aisle.
But reproductive rights groups and medical groups welcomed the decision.
“This is a game-changer,” says Judy Waxman of the National Womens Law Canter.
“The administration finally saw that it had nowhere left to go,” saidSusannah Baruch, who heads the Reproductive Health Technologies Project. But, she added, “I don’t expect to see the product at the corner pharmacy immediately.”
“This decision has been a long time coming,” added Nancy Northup, President and CEO of the Center for Reproductive Rights, which first sued in 2001 to try to force the Food and Drug Administration to make morning-after pills available freely over the counter.
The FDA itself thinks women and girls of all ages should be able to get the pills freely. Many medical studies have shown they are safe -- safer than aspirin, for example -- and effective in preventing conception when used early enough after unprotected sex.
But FDA was overruled by Health and Human Services Secretary Kathleen Sebelius in 2011 and, after an initial angry outburst by FDA administrator Dr. Margaret Hamburg, has complied. “They work at the pleasure of the Secretary,” Waxman said.
The pills now are only available with ID to girls aged either 15 or 17, depending on the product, with ID. Anyone younger or without ID needs a doctor’s prescription.
The political wrangling infuriated women’s health groups and also federal judge Edward Korman, who has issued a series of rulings trying to force FDA to follow its own advice and make the pills freely available. He also excoriated the FDA for making what he called a “sweetheart deal” with Teva Pharmaceutical Industries Ltd., allowing it to sell its Plan B/One Step product to girls as young as 15 while keeping older, cheaper and generic forms of the drug restricted to women 17 and older without a prescription.
Korman has called FDA “frivolous” and has accused the administration of acting in bad faith with political motivation.
Now the FDA has said it will obey Korman’s order if he approves a new plan to let Teva alone sell its product freely over the counter.
“It is unclear whether this will be enough to satisfy him,” Waxman said.
Teva had already started work on the new packaging for the FDA approval to provide Plan B/One Step to those 15 and older -- packaging that included plastic clamshell-style covers and specific labeling. It is possible FDA could allow the company to paste a label over this packaging saying the product is freely available to anyone.
How and where it will be displayed is up to individual retailers. So far no big chains have refused to stock it, but because the product is expensive -- up to $50 a pill -- it might be behind a locked case like some expensive razors.
“We think it is really important that the agency treat all of these emergency contraceptives in a fair manner and that means they should all be over the counter,” said Northup.
“If you take even a half a step back and look at the different products, the differences are infinitesimal and the notion that these lines are being drawn starts to look ridiculous,” added Baruch. And the other products, which involve taking two pills, are $10 to $20 cheaper than Plan B One-Step, which costs $40 to $50 a dose, they said.
The women’s health groups say they are not ready to call it a day. “We have battled this one out with two administrations,” Baruch said. “The path is not smooth or straight …There have been so many endless loops of political wrangling it has sometimes felt reminiscent of the movie ‘Groundhog Day’.”
The American Academy of Pediatrics (AAP), the American Congress of Obstetricians and Gynecologists and the Society for Adolescent Health and Medicine also welcomed the decision.
“For pediatricians, the science has always been clear: Emergency contraception is a safe, effective tool to prevent unintended pregnancy in adolescents of any reproductive age. Today, we are pleased that justice sided with science,” said AAP president Dr. Thomas McInerny. “Since nearly 80 percent of pregnancies in adolescents are unintended, allowing unrestricted access to emergency contraception products is a historic step forward in protecting the health of our patients who are sexually active.”
Northup said parents should feel uncomfortable with the idea of young teens buying contraception.
“Obviously, the idea of my soon-to-be teenagers being sexually active terrifies me as it terrifies any parent,” she said. “But public policy can’t be based on wishful thinking that a particular rule will stop teens from being sexually active. Teen pregnancy is an enormous public health issue.”
The United States has the highest teen pregnancy rate in the developed world.
"Today is a really wonderful opportunity for parents to talk to teenagers about sex and sexuality, and make sure that young people know about the best ways to prevent pregnancy," Leslie Kantor of Planned Parenthood Federation of America told NBC News.
“We have to acknowledge that sometimes teenagers, even those in emotionally healthy families, don’t necessarily communicate with their parents … and all of our teenagers need to have access to a backup methods of birth control,” Northup said.
FDA statistics show 90 percent of prescriptions for emergency contraception have gone to women 18 and older.