In a surprise development that riled some and pleased others, the emergency contraceptive drug Plan B One-Step — popularly called the morning-after pill — will remain available for girls 16 and younger by prescription only.
The Food and Drug Administration had earlier announced its intentions to permit sale of the drug over-the-counter for all ages, but on Dec. 7, Health and Human Services Secretary Kathleen Sebelius overruled that decision.
Predictably, reproductive health advocates cried foul over the development, and proponents of conservative family values hailed it.
Both Sebelius and Margaret Hamburg, commissioner of the Food and Drug Administration, say they made their decisions — opposing ones — based on scientific evidence. What's going on? Here's a look.
Plan B is a single 1.5-milligram dose of the synthetic hormone levonorgestrel that can decrease the chances of becoming pregnant by an estimated 59% to 94% if taken within 120 hours of unprotected sex.
That fairly broad percentage range stems in part from the uncertain science of how likely a women is to get pregnant after a single sexual encounter and where she is in her monthly cycle. Also important is when someone takes the emergency contraceptive: Effectiveness in preventing pregnancy is highest — in the 80% range — on the first day after intercourse.
"The key is to take it very early, very quickly," says Dr. Angela Chen, a UCLA obstetrician and gynecologist. "Once the egg is released, it's less effective."
The medicine works in several ways. It delays ovulation so that sperm have a reduced chance of finding an egg to fertilize before they die. And it changes the lining of the female reproductive tract in a way that slows sperm and egg transport, reducing the chances of the two coming together.
Those same lining changes can also inhibit implantation of a fertilized egg. This is considered an abortion by antiabortion advocates.
Plan B does not interfere with pregnancy once implantation has taken place.
Side effects of Plan B include nausea, which 1 in 4 women experience, and, less frequently, vomiting, abdominal pain, dizziness and breast tenderness. But beyond those immediate effects, doctors say Plan B is extremely safe and effective. "There are no medical contraindications, and it doesn't interact with other drugs," Chen says.
One reason it's safe is that, even though Plan B is similar to birth control pills, it has no estrogen in it — only levonorgestrel, a progestin hormone. That means Plan B does not carry the risks of blood clots that pills containing estrogen do. Also, Plan B is a single dose drug, not something women take every day (or nearly every day).
Advocates say that restricting access to emergency contraception leaves young teens facing unwanted pregnancy. Nearly 750,00 girls aged 15-19 get pregnant each year in the US, and 59% of those pregnancies are carried to birth. "It's preposterous to allow a teen to become pregnant when there is a safe, nontoxic method to prevent that from happening," says Corinne Rocca, a researcher at UCSF's Bixby Center for Global Reproductive Health.
Similar products are available over-the-counter in other countries, such as Belgium, Sweden, the Netherlands, South Africa and Thailand with no specific age restrictions. In Britain, France, Australia and China, emergency contraception can be purchased from pharmacists without a prescription but is kept behind the counter, as it is in the U.S. In Britain, buyers have to be at least 16. In France and Belgium, the medication is provided free of charge for girls younger than 18 without an age restriction.
In 2006, a two-dose formulation of the drug was approved for over-the-counter sale in the U.S. for women at least 18. In 2009, over-the-counter status for Plan B One-Step was granted for females 17 and older. The products are kept behind the counter because of the age restriction, though.
The FDA review for those decisions dates back to 2003, when an independent panel of reproductive health experts voted 23-4 to approve Plan B for all females of child-bearing potential, according to FDA spokeswoman Erica Jefferson.
Plan B's makers, Teva Pharmaceutical Industries, with U.S. headquarters in North Wales, Pa., appealed to the FDA in February to remove the prescription-only status for girls under 17. To support their application, they submitted data that specifically addressed the issues raised by dissenting committee members, which included evidence that adolescents could understand the package labeling.
This time around, the FDA reviewed all the data and decided approval was in order. Hamburg said in a statement that she agreed with the analysis. "There is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential," she wrote.
Sebelius directed Hamburg to deny Teva's application.
This is the first time that any Health and Human Services secretary has overruled an FDA decision, Jefferson says.
Sebelius, in the statement announcing her decision, said that her main objection was whether very young girls could use the drug appropriately. She said that 10% of 11-year-old girls are "physically capable of bearing children" and that the scientific studies reviewed by the FDA had not been done in girls that young.
The mention of 11-year-olds is "a total distraction," Rocca says.
It is true, she adds, that most of the studies are of age ranges such as 15 to 20 or 16 to 24. But, she says, few 11-year-olds are menstruating and even fewer are having sex. National data say 10% of girls are menstruating at age 11 (50% start by age 12½) and 6% report having had intercourse before age 13. "They're not included in studies because it is very difficult to find 11-year-olds who are having sex and need emergency contraception," she says.
Those opposed to Plan B cite reasons beyond that of abortion.
"It's just a matter of common sense," says Eric Scheidler, executive director of the Chicago-based Pro-Life Action League. "The idea that they could go into a pharmacy and buy these very powerful steroids without talking to [a parent] or a doctor is just completely mad." Scheidler adds that in cases of minor girls having sex with older men, emergency contraceptives helps the abuser, not the girl.
Studies have not found increased sexual activity or decreased contraceptive use with freely available Plan B. In a 2004 study published in the Journal of Pediatric and Adolescent Gynecology, 301 sexually active girls ages 15 to 20 were randomly assigned to two groups: One was given a supply of emergency contraception to keep at home and the other was told to call the clinic if they needed emergency contraception.
After six months, 8% of the girls given a supply of emergency contraception used it, compared with 6% in the group without a supply. This is not a statistically significant difference. But those who had the drug at hand used it sooner — on average, 11.4 hours after sex versus 21.8 hours in the control group. Used sooner, the drug is more effective.
There was no difference in frequency of sex between the groups over the six-month study period. And the group given emergency contraception reported more condom use, says Dr. Melanie Gold, a pediatrics specialist at the University of Pittsburgh who coauthored the study. "They told us things [about emergency contraception] like 'I didn't want to use it, but I was glad to know it's there,' and 'It reminded me to be careful,'" Gold says.
"There's nothing scientifically to hold up this age restriction," Gold adds. "And because of it, the drug's behind the counter for everyone. It's not just bad for kids under 17, it's bad for everybody."
The FDA is inviting the drug company to discuss next steps, Jefferson says, but she would not speculate on what those next steps might be.
And on Dec. 13, 14 Democratic members of Congress wrote a letter asking Sebelius to substantiate the scientific basis of her decision.
The same day, the Center for Reproductive Rights, an international organization that promotes reproductive freedom, announced it will reopen its 2005 lawsuit against the FDA, pressing them to remove age restrictions on emergency contraception.