Science trumped politics, but politics may still present problems for teens trying to purchase emergency contraception.
“A lot of stuff is going to happen over the next 30 days,” said Dr. Cora Breuner, a pediatric medicine specialist at the University of Washington.
Breuner was reacting to a judge’s decision Friday to overturn age restrictions on access to emergency contraception.
U.S. District Judge Edward Korman called those restrictions by the Food and Drug Administration “politically motivated and scientifically unjustified.” He ruled that levonorgestrel-based contraceptives such as Plan B One-Step and Next Choice should be available over the counter to all customers within 30 days.
“There is no serious health risk associated with use of Plan B as prescribed and intended, much less one that would make restrictions on distribution necessary for its safe use,” Korman wrote.
But the price of the levonorgestrel-based pills may remain a hurdle, along with potential changes in the way insurance companies and Medicaid reimburse for a pill that now is dispensed over the counter, Breuner said.
“The biggest issue and concern is that Medicaid continues to cover this,” she said. “That would be on a state-by-state basis.”
Many insurance plans, including Medicaid, may not reimburse as much, or at all, for such over-the-counter medication.
And while pharmacies may no longer ask for a prescription and identification, they may lock the pills up.
“It’s expensive,” Breuner said. “It probably will be locked up, not because of the type of medication but because it’s an expensive item that could be shoplifted.”
Age restrictions were among the barriers noted in a 2008 study that looked at access to emergency contraception for poor and minority teens in Philadelphia. Concerns about confidentiality also ranked high, according to the academy’s journal, Pediatrics.
Breuner, who co-authored the American Academy of Pediatrics’ position paper on emergency contraception, was among several medical professionals who praised the ruling Friday.
“I’m grateful the science has prevailed and that women will be able to access reproductive health regardless of age,” said Breuner. “We won the battle, but we have to continue the war, which is: We need to reduce our unintended pregnancy rate.”
Diana Ramos, California state officer for the American Congress of Obstetricians and Gynecologists, said: “The focus is on trying to prevent unintended pregnancies.… Whether it’s politics or science, the bottom line is preventing unintended pregnancies.”
Some 80% of teen pregnancies are unintended, according to studies cited by the pediatric academy.
Only half of teenage mothers ever graduate from high school, and their children are more likely to drop out as well, according to the Centers for Disease Control and Prevention. Those children also are more likely to have health problems, be incarcerated or become teenage parents themselves, the CDC reported. The net effect of all that on taxpayers is about $11 billion a year, according to the National Campaign to Prevent Teen and Unplanned Pregnancy.
Teens who sought emergency contraception generally resorted to it because of a failure of condoms, the pediatric academy reported.
The academy joined with the American Congress of Obstetricians and Gynecologists and the Society of Adolescent Health and Medicine in a statement supporting the decision, which they said “reflects overwhelming evidence that emergency contraception is safe and effective for all women of reproductive age.”
“Removing the age restriction is a positive step forward, but providers must continue efforts to educate adolescents about the proper use of emergency contraception,” said Debra Katzman, president of the Society of Adolescent Health and Medicine. “We must also work to ensure that emergency contraception is affordable for adolescents of limited means.”
James T. Breeden, president of the ACOG, said emergency contraception was “a safe, effective way to help prevent unintended pregnancy after a contraceptive failure, unprotected sex or sexual assault. We believe all EC products should be available over the counter.”
In 1999, Plan B became the first emergency contraceptive drug approved in the United States, but it was available only by prescription. Seven years later, the FDA allowed adults to buy the drug over the counter but still required prescriptions for customers under the age of 18.
The agency appeared ready to permit the nonprescription sale of the drug to people of all ages in 2011, but Health and Human Services Secretary Kathleen Sebelius overruled the agency and continued to require prescriptions for those 16 and younger. She cited concerns that the drug had not been tested in girls as young as 11, even though 10% of them are “physically capable of bearing children.” It was the first time an HHS secretary had overruled an FDA decision.
Her decision came on the eve of the 2012 election, prompting critics to charge that it was political, not scientific.
The Center for Reproductive Rights sued, arguing that the age and prescription requirements limited access to the drug for all women by creating confusion among pharmacists and clerks. Also, because pharmacists kept the drug behind counters, it was not available outside business hours.
The drug, a synthetic hormone, blocks ovulation and impedes the mobility of sperm. It does not cause an abortion in women who are already pregnant and does not harm a developing fetus. The pills are most effective when taken immediately after intercourse and preferably within 24 hours, although they are sometimes effective even after 72 hours.
Teva Pharmaceutical Industries, which makes Plan B One-Step, said that when the drug is taken as recommended, it is effective in 7 out of 8 cases.