FDA to decide whether birth control pill can be sold over the counter for first time in US

Christine Fernando, USA TODAY
·3 min read
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The FDA is set to meet in May to discuss whether to allow a birth control pill to be available over the counter in the U.S. for the first time.

HRA Pharma, a French drugmaker owned by the pharmaceutical company Perrigo, applied to switch its Opill pill from prescription-only to over the counter last July, the first time a pharmaceutical company has asked for permission to sell a birth control pill over the counter in the United States.

Opill has ben used with a prescription in the U.S. since it was approved in 1973, according to Perrigo. An FDA advisory panel was expected to review the application for the drug's over-the-counter approval in November, but it was delayed to May 9 and 10 to consider additional information.

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French drugmaker seeks to make birth control pill more available

Hormone-based pills are among the most common forms of birth control in the United States, according to the Centers for Disease Control and Prevention, but have always required a prescription.

"For a product that has been available for the last 50 years, that has been used safely by millions of women, we thought it was time to make it more available," said Frederique Welgryn, HRA’s chief strategy officer, when the company announced the application for over-the-counter use.

If Opill is approved for over-the-counter use, it would join emergency contraceptives like Plan B on pharmacy shelves.

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Advocates push for birth control pills without prescription

Reproductive rights organizations and leading medical associations have supported making birth control available without a prescription to overcome existing barriers to access and reduce the number of unwanted pregnancies.

The American College of Obstetricians and Gynecologists, the American Medical Association and the American Academy of Family Physicians support making birth control pills available over the counter.

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"Women's needs are nuanced, and it's about time their health options reflect that," Frederique Welgryn, global vice president for women's health at Perrigo, said in a statement.

Contraceptive pills are available without prescription across much of the globe, including in South America, Asia and Africa. Last year, a birth control pill was made available without prescription for the first time in the United Kingdom.

How does birth control pill Opill work?

Opill uses the synthetic hormone progestin to block sperm from the cervix, preventing pregnancy. Most other birth control pills use progestin and estrogen, and progestin-only pills like Opill are often recommended for people who can't take combination pills because of health reasons.

HRA Pharma is seeking to convince the FDA that women can safely screen themselves for conditions that raise the risk of rare but dangerous blood clots when using birth control pills. But estrogen, not progestin, accounts for most of the blood clot risk associated with oral contraceptives.

Still, for most women, the drugs are safe; only 3 to 9 suffer blood clots out of every 10,000 women taking combination pills annually, according to FDA data. That compares with 1 to five women suffering blood clots among 10,000 women who aren’t taking birth control.

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Contributing: The Associated Press

Contact Christine Fernando at cfernando@usatoday.com or follow her on Twitter at @christinetfern.

This article originally appeared on USA TODAY: Opill: FDA to decide on over-the-counter option for birth control pill