NEW YORK (Reuters Health) – A leading group of women’s physicians is urging drug regulators to make birth control pills available over-the-counter.
“We need to do something about the unintended pregnancy problem in the U.S. This is one way,” said Dr. Kavita Nanda, one of the authors of the statement by the American College of Obstetricians and Gynecologists (ACOG) and a scientist at the nonprofit research group FHI 360.
As Nanda and her colleagues wrote in their opinion statement supporting over-the-counter access, about half of all pregnancies are unplanned and they lead to $ 11 billion in costs to taxpayers each year.
Diana Greene Foster, a professor at the University of California, San Francisco who studies the impact of birth control on unplanned pregnancies, told Reuters Health the new opinion is backed by evidence.
“It’s been a long time that people (have felt) that over-the-counter makes sense,” said Foster, who is not part of the ACOG committee. “It’s clear that it would result in better access and fewer unintended pregnancies if women had better access to oral contraceptives.”
Currently, the birth control pill requires a prescription in the U.S.
Emergency contraception, which goes by the brand name Plan B, is available without a prescription, but must be acquired from a pharmacist.
Nanda said several surveys have shown that women would be more likely to use the pill if it were available over-the-counter, and studies have shown that women are at least as good as doctors at screening themselves for health reasons why they shouldn’t take the pill.
“There’s just an accumulating body of evidence that’s been published over the past three years that’s really been documenting the safety and effectiveness of over-the-counter access,” said Dr. Dan Grossman, the vice president for research at Ibis Reproductive Health.
Grossman sits on an ACOG committee, but not the one that penned the latest opinion.
One of the concerns about over-the-counter access is that the pill carries a small, increased risk of developing a potentially dangerous blood clot. But the risk of these clots is even greater during pregnancy.
“The pill is incredibly safe,” Grossman told Reuters Health. “I don’t have any safety concerns.”
COST ANOTHER BARRIER?
Grossman said he worries more about cost and insurance coverage, so that if the pill does become available without a prescription, women could actually access it.
“As we saw with Plan B, when it went over-the-counter the price was really high, $ 50 for a one-time use. If a daily pill were priced that high, I don’t think we would see the hoped-for increased use because the cost would create another barrier,” he said.
Under a provision of the Patient Protection and Affordable Care Act, also called Obamacare, women with health insurance will become eligible to receive birth control without any additional co-pays.
It’s not clear whether this would apply to over-the-counter birth control if the U.S. Food and Drug Administration approves such access.
The agency told Reuters Health it is willing to speak with drugmakers who wish to petition for a switch from prescription to over-the-counter availability.
“In order for a switch to occur, FDA determines whether the prescription requirements are necessary for the protection of the public health…Whether data would be needed for oral contraceptives to switch would require further review and discussion with (drug) sponsors,” Stephanie Yao, an FDA spokesperson, wrote in an email.
Foster said that, for supporters of over-the-counter access, ACOG’s opinion is encouraging.
“The fact that ACOG is coming out with a statement is a big deal, because they’re currently the gatekeepers. So when the gatekeepers are willing to let women have access to (over-the-counter) oral contraceptives, it does support it,” she said.
SOURCE: http://bit.ly/Ud6Y2v Obstetrics & Gynecology, online November 20, 2012.
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