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  • HRA Pharma has applied to market an OTC birth control pill called Opill.
  • The progestin-only pill would be the first of its kind in the United States.
  • The pill is safer than combined estrogen-progestin pills, experts say.
  • Doctors believe women can safely screen themselves for any risk factors.
  • Planned Parenthood applauds the move, saying it will help increase access to birth control.

On July 11, 2022, Perrigo Company plc announced that its subsidiary HRA Pharma had submitted an application to the Food and Drug Administration (FDA) for an over-the-counter birth control pill.

If the FDA approves this medication, it would be the first daily birth control pill available in the United States without a prescription.

The drug is currently sold by prescription under the brand name Opill.

HRA Pharma anticipates that an FDA advisory committee meeting will be held in the first half of 2023. They further note that it generally takes about 10 months for this type of application to be approved.

HRA Pharma says Opill is an oral contraceptive first approved in 1973, so it has a long history of safe usage.

According to Dr. Jessica Lee, an OB-GYN at the University of Maryland Medical Center and Assistant Professor at the University of Maryland School of Medicine, the hormone it contains, norgestrel, is chemically similar to progesterone, one of the hormones that a woman naturally produces during her menstrual cycle.

The American College of Obstetricians and Gynecologists says that when this type of pill is taken daily, it thickens a woman’s cervical mucous, making it difficult for sperm to enter the uterus and fertilize an egg. Here’s what ACOG says: Progestin stops ovulation, but it does not do so consistently. About 4 in 10 women who use progestin-only pills will continue to ovulate.

Lee explained that it differs from birth control pills containing two hormones, estrogen and progestin.

“The typical pill currently requires a prescription in the U.S. because the estrogen component comes with some increased risks and may not be a safe option for people with certain medical conditions.”

According to Planned Parenthood, although severe side effects are rare, birth control pills containing combined estrogen and progestin can increase the risk for heart attack, blood clots, stroke, liver tumors, and death.

Lee said that because HRA Pharma’s medication is a progestin-only pill, which is overall very safe, it is a good candidate for being sold over the counter.

However, she added that this doesn’t rule out selling birth control pills with both hormones in the future.

“There are several medical groups that feel the typical birth control pill with estrogen and progestin is also a good candidate for being sold over the counter, so perhaps that will be the next step.”

Lee further noted that there are certain risks when you are using birth control pills.

“Some risks of the pill occur if you use it if you are already pregnant if you have breast cancer, if you have liver disease, or if you have abnormal vaginal bleeding,” she said.

“Women can generally safely screen themselves for these risks without seeing a doctor,” she added.

Lee did caution, however, that Opill must be taken consistently for it to be effective. “There is less wiggle room for error,” she said, “and it is recommended to take Opill at the same time every day.”

Dr. Krishna Upadhya, vice president of quality care and health equity at Planned Parenthood Federation of America, said HRA Pharma’s move to sell Opill over the counter is significant in light of recent activity by the U.S. Supreme Court.

“The overturning of Roe v. Wade has brought a renewed sense of urgency to all sexual and reproductive healthcare services, including birth control access in the U.S.,” said Upadhya, “And while birth control is no substitute for abortion access, access to contraception is critical to folks’ ability to manage their own healthcare and control their own bodies.”

Upadhya cited statistics indicating that almost 9 out of 10 women of reproductive age use contraception. In addition, she said nearly 9 out of 10 adults agree that everyone deserves access to a full range of birth control methods.

“Birth control is not a nice-to-have,” she said. “It’s necessary.”

Upadhya said that the requirement for a prescription creates several barriers, including cost, transportation, child care, and privacy and confidentiality concerns.

“These barriers make it difficult for folks who do not have easy access to a health care provider and/or who face stigma or discrimination in the healthcare system — including Black and Latino communities and other people of color, LGBTQ+ folks, and young people,” said Upadhya.

“Along with curbing costs and eliminating age restrictions, making birth control methods available over-the-counter will make it easier for people to manage their own sexual and reproductive health,” she said.

She further noted that decades of research worldwide had established oral contraceptives as safe and effective.

Upadhya concluded by saying that Planned Parenthood is committed to expanding access to birth control for all who need it. She said the organization applauds HRA Pharma’s request as “a significant step in the right direction.”