FDA’s Final Decision on OTC Birth Control Pill Expected Soon
Opill is poised to become the first over-the-counter (OTC) daily hormonal contraception pill to be approved by the Food and Drug Administration (FDA).
- The FDA’s joint advisory committee endorsed the change in labeling for Opill by a vote of 17 to 0.
- If approved this summer, Opill could be available at pharmacies, grocery stores, and other venues later this year.
- People who live in rural areas, who are low-income, teenagers, and those experiencing intimate partner violence could especially benefit from an OTC birth control pill.
The unanimous endorsement of over-the-counter (OTC) Opill (norgestrel tablets) by the joint advisory committee of the Food and Drug Administration (FDA) may put the birth control pill on pharmacy shelves later this year.
“The advisory committee voted overwhelmingly to allow the birth control pill to move to over the counter in the United States,” says Victoria Nichols, MPH, the project director of the Free the Pill Project at Ibis Reproductive Health in Oakland, CA.
The FDA Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee voted 17 to 0 to recommend making the progestin-only birth control pill available without a prescription.1
“This is incredibly exciting. The advisory committee recommendation is a great first step,” says Kelly Cleland, MPA, MPH, an executive director of the American Society for Emergency Contraception (ASEC) in Lawrenceville, NJ. “We’re crossing our fingers that the FDA does the right thing and approves Opill for over-the-counter status. We believe having every option available is critically important for reproductive autonomy, especially in these times with abortion restrictions spreading across the country.”
In 2022, HRA Pharma, a Perrigo company, requested a switch from prescription to nonprescription availability for Opill, which is a daily progestin-only oral contraceptive pill. Opill was first approved in 1973 and marketed by Pfizer as Ovrette. It was discontinued in 2005 for business reasons, and HRA acquired the rights to Opill in 2015 with the goal of OTC availability, according to HRA Pharma’s sponsor briefing document.2
The briefing document notes a need for a nonprescription oral contraceptive in the United States because more than half of all women report an unintended pregnancy by age 45, and 72% of pregnancies occurring in adolescents are unintended.
“Unintended pregnancies have been linked to a number of negative maternal and perinatal clinical outcomes, such as premature delivery and low birth weight, as well as an increased risk of lower educational and economical attainment in women and children,” the briefing stated.
“The FDA raised questions [about safety] during the meeting about the application,” Nichols notes. “But what we know is the FDA advisory committee voted unanimously in support of this, and their decision is backed by decades of research and science that the birth control pill is safe and effective for over-the-counter use for people of all ages.”
Federal lawmakers urged the FDA to swiftly move forward on an OTC birth control pill. They also re-introduced the Affordability is Access Act to require insurers to fully cover OTC birth control without fees or out-of-pocket costs.3
OTC birth control pills already are available in more than 100 countries, Nichols says. “They’re some of the best-studied medicines on the market, with long-standing support from medical health experts,” she adds.
The advisory committee’s decision is not binding, but the FDA typically follows the committee’s recommendations. “We urged the FDA to follow their recommendation and to provide the pill without any further delay,” Nichols says. “It’s past time. We do expect they’ll make their decision by [the end of] summer.”
An OTC birth control pill will improve contraception access for adolescents and people who live in areas where accessing reproductive healthcare is challenging.
People who are uninsured, homeless, or live in rural areas may struggle to visit a clinic to obtain a birth control prescription. Also, patients might face discrimination in the physician’s office, including young people, those with low incomes, and people of color. They would benefit from an OTC birth control pill, says Mara Gandal-Powers, director of Birth Control Access at the National Women’s Law Center in Washington, DC.
“We know our healthcare systems are not set up in a way that makes them accessible for people of color,” Gandal-Powers says. “There are benefits to [the OTC pill] for anyone who can’t get into their doctor right away and can’t use insurance for privacy or other reasons. An OTC pill gives them a new option, and it’s a great advancement in that way.”
Barriers disproportionately affect some communities due to systemic barriers. “The reality is there are many barriers to getting birth control,” Nichols says. “These include having a prescription from a healthcare provider, having to travel to that appointment, getting child care, [or] taking time off from school or work.”
Teenagers and youth who rely on their parents’ insurance will especially benefit. “It would increase young people’s options for using effective birth control,” Nichols says. “The vast majority of people support and are interested in moving birth control to over the counter.”
The Free the Pill Project has worked to ensure any future birth control is paid for by insurance and is affordable to people of all ages. “The highest amount that adults and teens are willing to pay per month is $15 and $10 [respectively],” Nichols notes.4
“I’m very focused on insurance coverage [of the OTC pill] because under private insurance and Medicaid, contraceptives are covered without cost-sharing,” Gandal-Powers explains. “For all systems to be working properly, we need to make sure people can get that coverage at zero dollars.”
However, insurance involvement could pose a barrier for some, including young people who do not want their parents to know they need birth control. It also is problematic for people experiencing intimate partner violence, where reproductive coercion is common, Gandal-Powers explains. For instance, some partners will hide or throw away a woman’s birth control pills as part of their efforts to control her life. For these people, a low-cost OTC pill could be a life-changing option.
“We work with young people, and there are so many barriers to them to get contraception. One of those is having contraception going on their parents’ insurance,” Cleland says. “Some teenagers talk to their parents, but many are not able to do that.”
This is why the pill should be inexpensive and available OTC in many places besides pharmacies and grocery stores, Cleland notes. People should be able to order the pill online or buy it at gas stations and convenience stores — anywhere that sells condoms.
“You could have [Opill] at a homeless shelter or a place where people are going for Alcoholics Anonymous meetings. It could be in restrooms, next to condoms,” Gandal-Powers says. “There are a lot of different places we could think about where pills are available.”
ASEC has been working to expand distribution of OTC emergency contraception (EC), placing these in convenience stores and Dollar General stores, Cleland says. The same places that allow OTC EC also could offer Opill.
“It’s critical for someone to get their gas or cup of coffee and also get their pills without having to interact with the healthcare system or drive miles to a pharmacy,” Cleland explains. “There are at least 37 colleges with vending machines that include emergency contraception, and many more are underway. We get outreach from students and administrators all the time, looking at how to get this innovation on their campus.”
Contraceptive options that are easier to access and less expensive could help women improve their reproductive autonomy. “This is a growing movement, and we’re excited about putting that infrastructure in place across the country so Opill can [be included] with emergency contraception in these vending machines,” Cleland says. “Having emergency contraception and Opill available over the counter is like having your first and second line of defense at your fingertips.” Together, these go far in helping people avoid pregnancy, she adds.
There is another barrier that may require political and legal action, Gandal-Powers notes. Anti-abortion groups have been pushing a social media narrative that birth control is dangerous, suggesting they are planning to attack birth control access next. One possibility is for some states to require people to show a driver’s license proving they are 18 years or older before they can access Opill or EC.
“I am anticipating we’ll see states hostile to reproductive health that will attempt to restrict access to the OTC pill,” Gandal-Powers says. “We have seen, particularly in the last year post-Dobbs, an uptick in anti-birth control rhetoric on social media.”
The anti-abortion groups want people to think birth control is unsafe so they will accept restrictions, Gandal-Powers explains. “An age requirement and ID requirement would be very harmful,” she says. “We work closely with state advocates across the country and would try to stop a bill like that.”
The hope is the FDA will approve Opill for OTC purchase so women can easily use a safe and effective contraception without politically motivated restrictions. “It will make a difference in people’s lives,” Nichols says.
- Ernst D. FDA panel supports Rx-to-OTC switch of progestin-only birth control pill. Medical Professionals’ Reference. May 11, 2023. https://www.empr.com/home/news...
- HRA Pharma. Opill (norgestrel 0.075 mg tablets) for Rx-to-OTC switch. May 9-10, 2023. https://www.fda.gov/media/1678...
- Congresswoman Ayanna Pressley. Pressley, Murray, Bera, Ocasio Cortez re-introduce Affordability is Access Act, advocate for free over-the-counter birth control. May 18, 2023. https://pressley.house.gov/202...
- Grindlay K, Grossman D. Interest in over-the-counter access to a progestin-only pill among women in the United States. Womens Health Issues 2018;28:144-151.
The unanimous endorsement of over-the-counter Opill norgestrel tablets by the joint advisory committee of the FDA may put the birth control pill on pharmacy shelves later this year.
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