Morning-after pill to be available over the counter for ages 15 and above
(AP/ABC7) - The Justice Department is appealing a judge's decision lifting all age limits on the Plan B morning-after birth control pill and a cheaper generic.
The federal government says the judge who issued the ruling had exceeded his authority and that his decision should be suspended while the appeal is underway.
U.S. District Judge Edward Korman of New York had given the Food and Drug Administration until Monday to lift all age limits on Plan B and cheaper generic. The judge mandated that emergency contraception be sold just like aspirin.
On Tuesday, the FDA said anyone 15 or older could begin buying one brand, Plan B One-Step, without a prescription - two years younger than the current age limit of 17.
The question is whether Tuesday's action settles a larger court fight. Earlier this month, U.S. District Judge Edward Korman of New York blasted the Obama administration for imposing the age-17 limit, saying it had let election-year politics trump science and was making it hard for women of any age to obtain the emergency contraception in time. He ordered an end to all age restrictions by Monday, for Plan B and its generic versions.
The FDA said Tuesday's decision was independent of the court case and wasn't intended to address it. Technically, the FDA approved Teva's application to sell Plan B in this manner.
Udeepdhi Gopineepi of Arlington said, "Pregnancy at that time is definitely not welcome. They're not actually capable to handle at that age."
"I definitely think that's a bit young for young girls to make that kind of decision to do that, and especially at something where they may not have their parental consent to do. I think that's kind of a risky move," countered Lorton resident Sheri Evans.
The Justice Department remained mum on whether it planned to appeal Korman's decision, and the White House had no immediate comment.
The women's group that sued over the age limits said Tuesday's action is not enough, and it will continue the court fight if necessary.
Lowering the age limit "may reduce delays for some young women but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification," said Nancy Northup, president of the Center for Reproductive Rights.
The FDA said the Plan B One-Step will be packaged with a product code that prompts the cashier to verify a customer's age. Anyone who can't provide such proof as a driver's license, birth certificate or passport wouldn't be allowed to complete the purchase. In most states, driver's licenses, the most common form of identification, are issued at age 16.
"These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances, and we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women," Northup said.
Other contraceptive contraception advocates called the move promising.
"This decision is a step in the right direction for increased access to a product that is a safe and effective method of preventing unintended pregnancies," said Sen. Patty Murray, D-Wash. "It's also a decision that moves us closer to these critical availability decisions being based on science, not politics."
"I think it's a great idea because if they're going to engage in intercourse anyway, you might as well have that out there, because having a 15-year-old pregnant could be a huge devastation," says Cynthia Newby, a college student.
Teens are torn on the matter.
Fifteen-year-old Mia Stevenson of D.C. said, "I think it would be a supplement for them not to use condoms, but it might increase diseases and stuff."
"It is a good choice because there are a lot of young women out here... They're having children at a young age and then that's cause for abortions, which I don't think that...I don't believe in that," D.C. resident Armani Workmin, 17, said.
Social conservatives had opposed any efforts to loosen restrictions on sale of the morning-after pill, arguing that it was important for parents and medical professionals to be involved in such decisions involving young girls.
The group Concerned Women for America charged that health officials were putting politics and so-called progress ahead of the health of children as well as women.
"It makes no sense that kids need parental permission to take aspirin at school, but they're free to buy and administer Plan B," Penny Nance, CEO and president of CWA, said in a statement.
"It shows an alarming lack of concern for the safety of young girls and the fundamental rights of parents," says Anna Higgins of the Family Research Council.
Half the nation's pregnancies every year are unintended, and doctors' groups say more access to morning-after pills could cut those numbers. The pills contain higher doses of regular contraceptives, and if taken within 72 hours of unprotected sex, can cut the chances of pregnancy by up to 89 percent. But it works best if taken in the first 24 hours.
The FDA had been poised to lift all age limits and let Plan B sell over-the-counter in late 2011, when Health and Human Services Secretary Kathleen Sebelius, in an unprecedented move, overruled her own scientists. Sebelius said some girls as young as 11 are physically capable of bearing children but shouldn't be able to buy the pregnancy-preventing pill on their own.
President Barack Obama supported Sebelius' move and a spokesman said earlier this month that the president's position hadn't changed.
The Justice Department could appeal Korman's ruling and seek a stay. If granted, the appeals process would move through the courts, while Plan B is sold over the counter whenever Teva has the product repackaged to meet FDA's requirements.
Absent a stay, "we will want to go back to court as quickly as possible and ask the judge to hold them in contempt," said Janet Crepps, a senior counsel for the Center for Reproductive Rights.
The FDA said Tuesday that Teva had provided data proving that girls as young as 15 could understand how Plan B works and use it properly, without the involvement of a health care provider. Teva plans to conduct a consumer-education program, and indicated it is willing to audit whether stores are following the age requirement, the agency said.
FDA said its ruling applies only to Plan B One-Step, and not to generic versions of the pill which would remain behind pharmacy counters with the age-17 restriction.
If a woman already is pregnant, the morning-after pill has no effect. It prevents ovulation or fertilization of an egg. According to the medical definition, pregnancy doesn't begin until a fertilized egg implants itself into the wall of the uterus. Still, some critics say Plan B is the equivalent of an abortion pill because it may also be able to prevent a fertilized egg from attaching to the uterus, a contention that many scientists - and Korman, in his ruling - said has been discredited.