FDA to consider making prescription contraceptive pill available over-the-counter

A French pharmaceutical company has asked the U.S. Food and Drug Administration to allow it to sell a birth control pill over the counter, The New York Times is reporting.

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HRA Pharma, based in Paris, will announce Monday that it has asked the FDA to authorize the pill that is now available by prescription. HRA is asking the FDA to allow it to be sold over the counter.

A second company, Cadence Health, is also expected to formally request permission to sell its birth control pill over the counter. According to the Times, both companies have been in the pre-application process for several years.

The announcement comes weeks after the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization that overturned the landmark 1973 Roe v. Wade decision legalizing abortion.

It is not the first time the FDA has considered over-the-counter contraceptives. Levonorgestrel, known by its generic name “Plan B,” an emergency contraceptive pill, was approved for over-the-counter sales in 2011. The approval was not without controversy.

Because Plan B was approved for sale to teenagers 16 and younger, then-Health and Human Services Secretary Kathleen Sebelius overruled the decision after President Barack Obama voiced concerns.

A federal judge overruled Sebelius’s decision and allowed the pill to be sold over the counter.

“Years of legal wrangling finally got them to follow the science,” said Kelly Blanchard, the president of Ibis Reproductive Health, a global nonprofit group that partnered with HRA Pharma to conduct the research needed to submit the application.

“We hope they follow the science and approve without an age restriction in this case,” Blanchard told the Times.

The anti-abortion group Students for Life of America oppose contraceptive pills the group calls abortifacients.

“We do not take a position on contraception — which prevents pregnancy — but do on abortifacients that have as a deliberate part of their design the capacity and goal of ending a preborn baby’s life,” Kristi Hamrick, a spokesperson for the group, told The Washington Post.

The list of “abortifacients” that Students for Life of America opposes includes birth control pills, IUDs and Plan B, the Post reported.

In March, 59 House Democrats sent a letter to FDA Commissioner Robert Califf, asking for a “timely review” of any applications to approve the sale of birth-control pills over the counter.

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