Emergency contraceptives such as Plan B One-Step and its generic alternatives, including My Way, shown here, are making their way to over-the-counter sales based on a federal judge's ruling and a decision by President Barack Obama.

AP photo

Emergency contraceptives such as Plan B One-Step and its generic alternatives, including My Way, shown here, are making their way to over-the-counter sales based on a federal judge's ruling and a decision by President Barack Obama.

OTC morning-after pill sales coming

By Lauran Neergaard

The Associated Press

0 Comments | Leave a Comment

WASHINGTON – Don’t look for the morning-after pill to be sold next to condoms on drugstore shelves right away – but after a decade-plus fight, it appears that eventually will happen.

Backed into a corner by a series of court rulings, President Barack Obama’s 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 many 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 last week.

“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 of the issue, 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,” said Susannah Baruch of the Reproductive Health Technologies Project, which originally was founded in the 1980s to support access to the emergency contraceptive RU486.

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 last week how quickly that might happen.

Q: Why did the Obama administration change course?

A: The administration already had lost multiple rounds in court, and it appeared it would lose again. An appeals court recently ruled that 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.

Since some version was going to be sold over the counter no matter what, the U.S. Food and Drug Administration said it should be the simpler one-dose Plan B One-Step, not two-pill versions originally designed to be taken 12 hours apart.

Q: Generics are cheaper. Will they be sold over the counter, too?

A: That’s not clear. Plan B One-Step might have some exclusive marketing rights that would affect how and when other one-pill versions could sell, and the F.D.A. has no plans to allow unrestricted sales of two-pill generics. Plan B One-Step costs about $40 to $50, and generics typically cost $30 to $40.

Q: How did this controversy start?

A: In 2011, the F.D.A. was preparing to allow over-the-counter sales of the morning-after pill with no age limits when Kathleen Sebelius, the U.S. secretary of health and human services, overruled her own scientists in an unprecedented move. She said she was worried that girls as young as 11 would use the pill without 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.

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.

Some groups also argued that Plan B is the equivalent of an abortion pill because it might be able to prevent a fertilized egg from attaching to the uterus. That contention scientifically has been discredited.

Q: Doesn’t this situation 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 identification for purchases of cold medicines containing 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: Last fall, the American College of Obstetricians and Gynecologists said birth control pills are safe enough to be sold without a prescription, too. But no manufacturer has indicated it wants to try.

Associated Press writer Josh Lederman contributed to this report.