Drugmaker seeks FDA approval for over-the-counter access to birth control pill

·3 min read

A pharmaceutical company is seeking to sell a birth control pill over the counter in the United States for the first time.

For decades, people taking hormone-based pills, the most common form of birth control in the country, have required a prescription. But HRA Pharma, a French company, submitted an application to the Food and Drug Administration on Monday to sell the pills without a prescription.

Birth control pills have typically required a prescription so that doctors and other health care workers can screen for the possibility of rare blood clots in people taking the pills.

“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,” Frederique Welgryn, HRA’s chief strategy officer, said in a statement, the Associated Press reported.

The application only applies to HRA's medication, which would be marketed under the drug’s brand name, Opill.

Opill is a kind of birth control that only contains the hormone progestin. This type of medication is also known as the mini pill. Another common kind of birth control pill is known as the combination birth control pill, which contains both estrogen and progestin.

The FDA in a statement to USA TODAY said it generally “cannot comment on pending applications before the agency or its interactions with any manufacturers about their investigational products.”

Should the FDA approve the medication, the move could come next year.

Several medical organizations have backed over-the-counter access for oral contraceptives. The American College of Obstetricians and Gynecologists in 2019 said hormonal contraception of all kinds should be available to people over the counter, with no age restrictions.

People can currently get Plan B or other levonorgestrel pills, called emergency contraceptives, over the counter. You can also order some levonorgestrel pills online.

Dr. Meera Shah, chief medical officer of Planned Parenthood Hudson Peconic in New York, previously told USA TODAY that you cannot take Plan B too much. However, Planned Parenthood notes that it may not be an ideal long-term birth control option because of the cost, some side effects and other factors.

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HRA Pharma has spent over five years conducting studies required by the FDA, including a trial of over 1,000 women taking the birth control medication for six months.

The Oral Contraceptives Over-the-Counter Working Group, a combination of reproductive health organizations, research groups, advocacy groups and others, contributed funding to HRA’s research.

The application comes as reproductive rights are in the spotlight in the U.S. The Supreme Court last month overturned its 1973 decision in Roe v. Wade, the landmark decision that guaranteed abortion access across the country. HRA has said the timing of its application was unrelated to the court’s decision, according to multiple reports.

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President Joe Biden last week announced that his administration is taking steps to protect access to abortion, including protecting access to medication.

Interest in mifepristone, which is used with another medication to end pregnancy that is less than 70 days developed, also spiked after the court’s decision, though so-called “abortion pills” are distinct from birth control medication and combination pills.

Contributing: Wyatte Grantham-Philips, USA TODAY; Associated Press

This article originally appeared on USA TODAY: French drugmaker seeks over-the-counter birth control in the US