Panellists say that making the contraceptive available in the US without a prescription will benefit women’s health.
“The scientific evidence is clear that over-the-counter access to contraception without age restrictions can be accomplished safely, and the benefit of increased access is significant,” said Kristyn Brandi, a gynecologist representing ACOG at the meeting. She pointed out that many people seeking contraception to prevent unwanted pregnancies face obstacles, including cost barriers and difficulties obtaining an appointment with a physician.
To be sold over the counter in the United States, a drug must meet certain criteria. It should be used for a condition that a user can self-diagnose — in this case, the desire to prevent an unwanted pregnancy. The user should also be able to administer the drug safely and effectively without the help of a health-care provider. With Opill, that means taking one pill every day at the same time. The last criterion is that the drug should have a low potential for misuse and abuse.
It is unusual to bring up this issue, Grossman says. “With this kind of application to move a medication to non-prescription status, the only thing you should be looking at is whether people use it appropriately, according to the instructions and whether they can appropriately select for use or not,” he says.questioning the agency’s decades-ago approval of the abortion pill mifepristone
During the portion of the meeting when members of the public could participate, some pushed back on the concerns. “Women can understand labels, including contraindications,” said Caroline Renko, a manager at PharmedOut, a project at Georgetown University in Washington DC that educates physicians about how pharmaceutical companies influence prescribing.
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