The medical community has largely been supportive of the Obama administration's decision Monday to reverse course and allow over-the-counter access to the emergency contraceptive Plan B One-Step to women and girls of all ages. Plan B One-Step is a single dose of the hormone levonorgestrel, which multiple studies have proven safe for women and that has been used in birth control pills for years.
But several medical groups remain concerned about the decision, citing a lack of research of the effects of the pill on young girls.
"When you're talking about girls between the ages of 11 to 16, I'm not fully satisfied with the studies that are out there," says Michelle Cretella, vice president of the American College of Pediatricians, a socially conservative medical group. "The studies have to be truly longitudinal and truly representative of the teen population" – studies not yet available because Plan B One-Step has only been around since 2009.
Donna Harrison of the group ProLife ObGyns is also worried about a lack of long-term studies.
"It is very possible that such interference with the part of the young girls brain that controls her cycles may cause her significant fertility problems later," she says. "At the very least, this is a safety issue that should have been explored before this drug was released over the counter instead of treating our young girls as experimental guinea pigs."
Possible side effects for Plan B One-Step include changes in the menstrual cycle, as well as nausea, fatigue, vomiting, diarrhea and abdominal pain, according to the drugmaker.
Plan B is intended only for emergency use, but Cretella worries that teens may end up using it more often.
The Food and Drug Administration, however, has said there is no reason to believe that's true. In a statement on its approval of Plan B for women 15 years of age and older, the FDA cited a study provided by Plan B maker Teva Pharmaceutical Industries, that showed teens "understood that the product was not for routine use."
That same study, the FDA said, showed the pill was both safe and effective for use by young teens.
The FDA first approved access to Plan B with a prescription in 1999; by 2006, the FDA said women 17 and older could get it over the counter but that younger women still needed the prescription. When scientists at the FDA said in 2012 that Plan B should be available without age restrictions, Health and Human Services head Kathleen Sebelius overruled them because she said more research was needed on the pill's effects on young girls.
"I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age," she wrote in a statement.
Despite Sebelius's comments, most medical groups say there is no cause for concern. (A U.S. federal judge also criticized her action as "political interference.")
The Society for Adolescent Health and Medicine, for example, says a number of studies have been conducted on the effects of emergency contraception on young girls, though not longitudinally.
Amy Campbell, chair of the advocacy committee at SAHM, points to a World Health Organization study on uses of emergency contraception by women as young as 14 that found that the dose was effective and that side effects were mild, and to a Shanghai-based Planned Parenthood Research study that found use of an emergency contraceptive pill was safe, effective and resulted in few "adverse events."
"Hormonal contraceptives have been used for decades and have an extremely safe track record," Campbell said. "So we feel good about the science that is out there. But this doesn't mean there shouldn't continue to be more research."
Dr. Cora Breuner of the American Academy of Pediatrics says her confidence in Plan B stems from the availability of long-term data about girls on the birth control pill.
"We know from repeated reviews there are girls on birth control and have been for years, and they have had no untoward effects," she says. "This isn't that different." The birth control pill and Plan B both contain the hormone progesterone, but Plan B includes it at higher levels.
Breuner also points out that the FDA approves a number of medications before having conducted studies that involve repeated observations of the same thing – such as a woman's fertility – over a long period of time.