What Is Next for the First OTC Birth Control Pill Approved by the FDA?
September 1, 2023 6 minutes read
It took contraceptive care advocates more than two decades, but they achieved success on July 13, when the U.S. Food and Drug Administration (FDA) approved Opill, the first over-the-counter (OTC) hormonal birth control pill, for use in the United States.
“The FDA’s decision was a real victory for equity, public health, and evidence-based research,” says Victoria Nichols, MPH, project director of the Free the Pill Project at Ibis Reproductive Health in Oakland, CA. “Over-the-counter birth control pills are supported across the aisle. It’s a bipartisan issue with bipartisan support, and the overwhelming majority of people in the United States support birth control.”
Ibis Reproductive Health and other organizations have published numerous studies over the past decade about both the high level of public need for and interest in an OTC birth control pill and about its safety and effectiveness.1-4
For example, the authors of a 2013 study found that nearly one-third of adult women at risk of unintended pregnancy said they were strongly or somewhat in favor of oral contraceptive pills being available over the counter.1
The resutls of a different study revealed that nearly 30% of women who tried to obtain a prescription for hormonal contraception faced problems obtaining the prescription or refills.2
Ninety percent of likely users of an OTC birth control pill said they would use it long-term. Also, most said they would pay up to $20 per month for the OTC pill.3
In April 2023, Contraceptive Access Initiative published a nationwide poll revealing that oral birth control pills are viewed favorably by eight in 10 people. More than seven in 10 voters support an OTC birth control pill.4
The FDA’s approval came without strings attached. People younger than age 18 years can buy Opill off the shelves. States may have some policies regarding its distribution, but on a federal level there should be no barriers to its use.
“This is a progestin-only pill, which is safe for almost anyone,” Nichols says. “It’s safe and effective.”
Having a birth control pill available to anyone who can visit a grocery store, pharmacy, and other places where OTC drugs are sold is one of the rare, good things that has happened in reproductive health in the past year, says Kristyn Brandi, MD, MPH, FACOG, the Darney-Landy Fellow at the American College of Obstetricians and Gynecologists (ACOG) in Washington, DC.
“For me and in the context of other reproductive health attacks, this was a ray of sunshine,” Brandi says. “Plus, the FDA had lots of questions about whether or not this contraception would be good for certain groups like young people and people with obesity. The end result was they did not have any restriction.”
Unrestricted, the pill’s access will benefit people who are particularly marginalized and face economic, geographical, and other barriers to reproductive healthcare.
An estimated 19 million women of reproductive age live in a contraceptive desert, a place where they do not have reasonable access to contraceptive healthcare, according to Power To Decide, a contraceptive advocacy organization.5
For those women, having an effective and safe birth control pill available at their local convenience store, grocery, or pharmacy would be a big improvement in contraceptive access.
The only unknown barrier is the pill’s cost. Advocates are asking the manufacturer to keep the price as low as possible so it is accessible to all.
“I hope we’ll get more information about what this will look like in practice, particularly when the medication comes out,” Brandi says. “Particularly the price — having this pill over the counter may or may not mean insurance will cover it, and if they don’t cover it, what will the price be?”
The drug has existed for decades, so Brandi hopes the cost of manufacturing and promoting it will not be high, so the manufacturer can keep the price reasonable.
Other ongoing concerns are state restrictions and the chill factor that has permeated so much of reproductive healthcare since the U.S. Supreme Court overturned Roe v. Wade and women’s constitutional right to abortion care.
“We’re in a climate where a lot of reproductive healthcare is being challenged at the state level,” Brandi says. “There’s a lot of discomfort with emergency contraception being over the counter and having no age
restrictions.”
There was no news of states acting to restrict Opill in the first few weeks after it received FDA approval, but that possibility is always a concern, Brandi adds.
“I worry about that and hope it won’t be the case,” Brandi says. “Even though there may not be an overt restriction, we’ve seen with emergency contraception that there are some places that don’t stock it regularly, so it’s not reliable and available when people need it.”
Pharmacies and grocers could enact their own restrictions for how the drug is distributed. Some may place it as an OTC drug people have to request rather than just take off a shelf.
“It’s concerning that individuals like pharmacists could create barriers to people in their community,” Brandi says.
The OTC birth control pill holds promise to improve equity in access to contraception. Research shows that people face barriers to contraception when they must obtain a prescription.
“Nearly one-third of adult women who have ever tried to refill a prescription for birth control faced at least one challenge to accessing birth control in a year,” Nichols explains. “I just did a study about Black, Indigenous, AAPI [Asian, Asian American, or Pacific Islander] folks, and 40% faced at least one challenge to accessing birth control in a year.”
People who are not using any contraception or who are using a less effective method are interested in an OTC birth control pill. It will give them greater control over their reproductive health.
For example, teenagers face unique barriers to access. They may not have transportation or the ability to take time off from school or work. They need to find a healthcare provider, and if they want to use insurance, they may worry about their parents finding out about their birth control.
“Ensuring this is equitably available to young people and making sure they can plan their health and futures is an important piece of this work,” Nichols says. “We had numerous young people testify to the FDA about their experience and not having barriers to contraception for OTC products, and their voice was key to that advisory committee meeting about the importance of young people having access to over-the-counter birth control.”
Free the Pill is spreading the word about the OTC contraceptive pill through a coalition of hundreds of reproductive justice advocates and multilingual materials.
“We are looking to work with reproductive justice partners on this, and we hope the materials the [pill manufacturer] puts out will reach people of all backgrounds,” Nichols says.
Clinicians emphasized there was no medical reason to place restrictions on the pill, and they supported access to youth, as well.
“ACOG and other organizations are excited that people will be able to access this care and not have barriers — like us — to prevent the care they need,” Brandi says.
For people who have already received a birth control pill prescription from a physician, an OTC option means they can prevent having a few days without birth control while they wait to see their clinician about a refill. “This is a great opportunity for people who have difficulty accessing care as it stands right now,” Brandi says.
REFERENCES
- Grossman D, Grindlay K, Li R, et al. Interest in over-the-counter access to oral contraceptives among women in the United States. Contraception 2013;88:544-552.
- Grindlay K, Grossman D. Prescription birth control access among U.S. women at risk of unintended pregnancy. J Womens Health (Larchmt) 2016;25:249-254.
- Grindlay K, Key K, Zuniga C, et al. Interest in continued use after participation in a study of over-the-counter progestin-only pills in the United States. Womens Health Rep (New Rochelle) 2022;3:904-914.
- Contraceptive Access Initiative. Overwhelming public support for the pill OTC. April 2023.
- Power to Decide. Lack of Access = Lack of Power to Decide. July 25, 2023.
It took contraceptive care advocates more than two decades, but they achieved success on July 13, when the U.S. Food and Drug Administration approved Opill, the first over-the-counter hormonal birth control pill, for use in the United States.
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