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Headline News

June 12, 2013

OTC morning-after pill sales coming — but not yet

WASHINGTON — Don’t look for the morning-after pill to move next to the condoms on drugstore shelves right away — but after a decade-plus fight, it appears it really will happen. Backed into a corner by a series of court rulings, the Obama administration has agreed to let the Plan B One-Step brand of emergency contraception sell over the counter to anyone of any age.

There still are a lot of details to be worked out, including whether a federal judge agrees that the government has gone far enough or whether cheaper generics can be sold without restrictions too.

But the move does mark a major societal shift in the long battle over women’s reproductive rights, and influential doctors’ groups welcomed the step Tuesday.

“Allowing unrestricted access to emergency contraception products is a historic step forward in protecting the health of our patients who are sexually active,” said Dr. Thomas McInerny, president of the American Academy of Pediatrics. “The science has always been clear: Emergency contraception is a safe, effective tool to prevent unintended pregnancy in adolescents of any reproductive age.”

On the other side, social conservatives argue that the drug’s availability undermines parental supervision, and accuse the administration of politicking.

“We are disappointed that this administration has once again sided with its political allies and ignored the safety of girls and the rights of parents,” said Anna Higgins of the Family Research Council.

A look at the medical, legal and political issues surrounding over-the-counter sales of backup birth control:

Q: How quickly will emergency contraceptives be sold on the drugstore shelves?

A:  “I don’t expect to see the product at the neighborhood pharmacy instantly,” cautioned Susannah Baruch of the Reproductive Health Technologies Project.

First, U.S. District Judge Edward Korman in New York must decide whether the Obama administration’s decision complies with his April order that the government lift all age restrictions on nonprescription sale of morning-after pills. Korman wanted unrestricted access to all brands, not just the best-selling Plan B One-Step. Generic versions are cheaper, and the judge didn’t want to place a disproportionate burden on the poor and minorities. But he did say the government could try to make the case that one-pill versions like Plan B One-Step are better than the two-pill versions.

Court case aside, manufacturer Teva Women’s Health must submit an application to the Food and Drug Administration to begin sales with no age limits. Teva didn’t say Tuesday how quickly that might happen.

Q: What if my condom breaks in the meantime?

A: The old rules remain in effect. Four or five versions of emergency contraceptives are sold without a prescription only to customers who can prove to a pharmacist that they’re 17 or older.

For Plan B One-Step, the age was soon to drop to 15, but those sales haven’t begun yet. It’s a moot point now anyway.

Q: Why did the Obama administration change course?

A:  The administration gave in because it already had lost multiple rounds in court, and it appeared it would lose again. Just last week, an appeals court said girls of any age could buy the two-pill generic emergency contraception without a prescription while the government appealed Korman’s initial ruling. That set the stage for massive confusion in drugstores and signaled that the appeal could fail. If the messy battle reached the Supreme Court, it would be a big distraction to President Barack Obama’s second-term goals, including immigration legislation, a budget deal and efforts to combat climate change.

Since some version was going to be sold over the counter no matter what, the FDA said it should be the simpler one-dose Plan B One-Step, not two-pill versions originally designed to be taken 12 hours apart — even though studies show taking them simultaneously is OK.

“It was the decision, given that court ruling, to proceed with making the simpler version of Plan B available, because at the very least, that addresses some of the concerns about the ability of younger girls to use that medication,” White House spokesman Jay Carney  said.

Q: Generics are cheaper; will they be sold over the counter too?

A: That’s not clear. Plan B One-Step may get some exclusive marketing rights that would affect how and when other one-pill versions could sell, and the FDA has no plans to allow unrestricted sales of two-pill generics. Women’s groups pledged to continue pushing for all versions to be treated the same. Plan B One-Step costs about $40 to $50, and generics typically cost $30 to $40.

Q: How did this controversy start?

A: Back in 2011, the FDA was preparing to allow over-the-counter sales of the morning-after pill with no age limits when Health and Human Services Secretary Kathleen Sebelius overruled her own scientists in an unprecedented move. She was worried that girls as young as 11 would use the pill with no supervision, a concern that Obama echoed.

Doctors’ groups and contraceptive advocates, however, argue that easier access to emergency contraception could cut unintended pregnancies, and that the drug is safe even at younger ages. Korman said hardly any 11-year-olds would use the pill, calling Sebelius’ decision political pandering in an election year.

Legally, the requirement is that over-the-counter drugs are safe and effective if used as intended, said Nancy Northup of the Center for Reproductive Rights, noting that parents don’t know whether their 11-year-old is buying Tylenol to treat a hangover either.

Q: Why was there opposition?

A: Social conservatives argued that easier availability would encourage girls to become sexually active, and that it wasn’t safe for them to take the pills without a doctor’s or parent’s involvement. And some groups argued that Plan B is the equivalent of an abortion pill because it may be able to prevent a fertilized egg from attaching to the uterus — a contention that has been scientifically discredited.

Q: Wait, doesn’t this mean that people will have easier access to emergency contraception than to some cold medicines?

A: Age wasn’t the concern with cold medicines; it was a law enforcement issue. A federal law required an ID for purchases of cold medicines containing a particular ingredient, pseudoephedrine, because it can be used to manufacture methamphetamine.

Q: So if emergency contraception is OK over the counter, what about regular birth control pills?

A: Stay tuned. Just last fall, the American College of Obstetricians and Gynecologists — the doctors who make money writing prescriptions for the pill — say it’s safe enough to be sold without a prescription too. But no manufacturer has indicated it wants to try.

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