The first steps toward over-the-counter birth control in the US are finally underway

Emily Crockett · Friday, December 30, 2016, 4:28 pm

A French pharmaceutical company will apply for FDA approval to make a progestin contraceptive pill available over the counter in the US. It’s about time.

Over-the-counter birth control is very likely to become a reality in the United States, Vox has learned. It will be several years, at least, before the Food and Drug Administration actually approves an oral contraceptive pill for use without a prescription — but the first steps of the process are underway.

The best way to prevent unwanted pregnancy is to make it as easy as possible for women to access birth control. But in most states, women can only get hormonal contraception with a prescription from a doctor — which requires time and money for doctors’ visits that some women just don’t have. And since oral contraceptive pills are incredibly well-studied and incredibly safe, many advocates and experts think it’s time to make them available over the counter without a prescription.

The American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians agree that oral contraceptives are appropriate for over-the-counter use. The idea even has bipartisan support in Congress, although there are sharp disagreements over issues like whether and how insurance should pay for it.

The problem with making over-the-counter birth control a reality hasn’t been evidence, or even necessarily politics. The problem has been finding a pharmaceutical company that is actually willing to go through the long slog of getting one of its own drugs approved by the FDA for over-the-counter use.

But now that company has been found. HRA Pharma in Paris is partnering with advocates and experts from Ibis Reproductive Health, an international nonprofit research organization for reproductive health, to start the process of bringing an over-the-counter oral contraceptive to the US market.

“At HRA, we are proud of our pioneering work to expand access to contraception for millions of women,” the company told Vox in a statement. “Oral contraceptives are some of the best-studied medicines on the market today and enjoy longstanding support from medical and public health experts.”

Ibis president Kelly Blanchard told Vox that she doesn’t want to speculate on how long it will take to bring the pill to market, and that the exact name or chemical composition of the pill isn’t public yet. But their aim is to submit an application to the FDA “within a few years,” she said, and some pieces of the application and research are already underway.

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http://www.vox.com/2016/12/30/14120874/birth-control-over-the-counter-fda-ibis-hra-pharma