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A non-prescription pill

This sounds like a good idea.

If you’re one of the estimated 10 million people in the United States taking oral contraception, you probably needed a prescription to get it. But that could soon change: In July, a Paris-based company, HRA Pharma, announced it asked the US Food and Drug Administration for permission to sell its progestin-only birth control pill over the counter. For the first time since its approval in 1960, the Pill may be available with no requirement to consult a health care professional—a significant hurdle for those most in need of the medication.

The US wouldn’t be the first country to #FreeThePill; in fact, oral contraceptives are available without a prescription in more than 100 countries. That’s because the Pill is nearly 100 percent effective when taken regularly, and safe for most people. Blood clots, a risk associated with the drug, are serious, but rare in today’s formulations: Every year, between one and five out of 10,000 women who are not on hormonal birth control or pregnant experience a blood clot; for people on the combination (estrogen and progestin) pill, the risk rises to between three and nine out of 10,000 people. And there’s no increased risk of clots for those on a progestin-only pill. In recent years, dozens of US medical organizations have declared support for a nonprescription pill, and an overwhelming majority of voters appear to be in favor of making the change.

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An FDA approval would be a “step forward,” California Latinas for Reproductive Justice Communications Director Susy Chávez Herrera says, “in terms of expanding health care access, and folks in our community having bodily autonomy.”

A decision from the FDA is likely several months away: A panel of independent experts was set to meet on November 18 to discuss HRA Pharma’s proposal, but the meeting was postponed, reportedly to accommodate more data. Now, the agency is expected to weigh in on over-the-counter birth control sometime next year.

In any case, the fight for access won’t end at the pharmacy. For one, the FDA typically only considers one product at a time; a green light for HRA Pharma’s pill won’t automatically free up other options. (So far, just one other company, Cadence Health, has said it plans to ask the FDA for approval to sell its combination pill over the counter, but has yet to complete the necessary research trials.) And just because a drug is available doesn’t mean it will be affordable. “Having the FDA approve an over-the-counter birth control pill would be a huge win,” Chávez Herrera says, “but it would not be complete if it was not accessible to the people that really need it.”

Research underscores the need to keep costs low. A 2018 study from Ibis found that generally, adults are willing to pay up to $15 for a one-month supply. “If the price goes up much more than that,” says Daniel Grossman, a professor in the department of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, and an author of the study, “then interest really kind of bottoms out.” When I asked HRA Pharma how much its pill would cost, their Chief Strategic Operations and Innovation Officer Frederique Welgryn told me in an emailed statement that the company would “set an acceptable price tested with consumers” and is working on developing a financial assistance program.

I’m in favor of anything that increasing reproductive freedom and gives women more control over their lives. I feel confident that the forced birth fanatics will fight back, via state laws that put restrictions on pill access and lawsuits that seek out friendly judges, but that’s a fight we should be willing to have. Whether this would blunt their already ongoing environmental attack is not known to me. Be that as it may, the important thing is finding ways to move the ball forward in whatever way we can.

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