Over-the-Counter Birth Control Pill Could Be Available in the US by Year’s End | Clinical Pharmacy and Pharmacology | JAMA
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The US is now closer than ever to joining the ranks of the more than 100 countries that already make oral contraceptives available without a prescription, a move proponents say is especially urgent in the post–Roe v Wade era.
After 2 days of presentations by the pill’s sponsor, US Food and Drug Administration (FDA) scientists, and members of the public, 17 FDA advisory committee panelists, voted unanimously May 10 that the benefits of providing a progestin-only birth control pill over-the-counter outweighed the risks.
The panel’s vote came almost exactly 63 years after the FDA approved Enovid, the world’s first oral contraceptive. Advisory committee decisions aren’t binding, but the FDA is more likely to follow them when the vote is unanimous.
The agency is expected to act on the matter later this summer, and, if approved, Perrigo’s Opill (0.075 mg norgestrel) could be on drugstore shelves by the end of the year or the first quarter of 2024, Frédérique Welgryn, MS, global vice president for women’s health at Perrigo, told JAMA in a statement.
For now, the only over-the-counter contraceptives in the US are emergency contraceptives or “morning-after pills,” one type of which contains the progestin levonorgestrel; male and female condoms; and spermicides.
But medical professional organizations, including the American Medical Association, publisher of JAMA, and other advocates have long supported making birth control pills and other hormonal contraceptives available without a prescription in the US. Doing so would make effective contraception more accessible to adolescents and adults, and, it is hoped, reduce the risk of unintended pregnancies, which currently represent approximately 42% of US pregnancies.
A progestin-only pill seems like a logical first step toward a broader array of over-the-counter contraceptives because such pills are highly effective, have a strong safety profile, and don’t require an examination or testing to determine eligibility.
Although Opill isn’t on the market as a prescription drug, the FDA first approved a 0.075-mg norgestrel birth control pill (Ovrette) a half-century ago (it hasn’t been marketed since 2005 for business reasons). According to the FDA briefing document for advisory committee members, the main contraindications for Opill are breast cancer or other progestin-sensitive cancer, now or in the past; known or suspected pregnancy; undiagnosed abnormal vaginal bleeding; and benign or malignant liver tumors.
Perrigo already sells a 0.075-mg norgestrel pill, under the brand name Hana, without a prescription in the UK. The UK Medicines and Healthcare products Regulatory Agency approved switching progestin-only pills from prescription to nonprescription status in 2021. But the UK has a nonprescription category that requires consulting with a pharmacist before purchasing a drug, so technically, nonprescription progestin-only pills are available there from behind the pharmacy counter, not over-the-counter.
That arrangement is similar to what can be found in 21 US states and the District of Columbia, according to the National Alliance of State Pharmacy Associations. Those jurisdictions have statutes or regulations that allow pharmacists, who typically are more accessible than physicians, to prescribe contraceptive pills and, in some cases, patches.
Only a small minority of oral contraceptive users in the US take a progestin-only pill, typically people who have contraindications for a combination pill that contains estrogen as well as progestin.
Physicians may be less likely to prescribe progestin-only pills because they think they’re less effective than pills containing estrogen and progestin, a recent review article noted. However, based on 54 studies, the authors concluded that only 2 pregnancies are expected to occur for 100 people who used progestin-only contraceptive pills for 1 year. This failure rate is much lower than the currently accepted estimate of 7%.
University of California San Francisco obstetrician and gynecologist Daniel Grossman, MD, attributes the country’s low use of progestin-only pills in part to a lack of marketing of off-patent products. Another factor could be that progestin-only pills are supposed to be taken at the same time every day and are associated with irregular menstrual bleeding, Grossman said in an interview.
Some progestin-only pills, including those containing norgestrel, prevent pregnancy mainly by making cervical mucus hostile to sperm, an effect thought to be short-lived, necessitating that the contraceptives be taken at the same time every day. But 1 small 2022 study funded by Opill’s original sponsor HRA Pharma, which was bought in May 2022 by Perrigo, suggested that delaying taking 0.075-mg norgestrel by up to 6 hours or even skipping 1 dose may not jeopardize the pill’s efficacy.
And Grossman coauthored a recent study that concluded that people who participated in a US trial of over-the-counter Opill found the menstrual bleeding to be acceptable. Labeling for a nonprescription progestin-only pill “should provide clear messaging about bleeding changes users may experience,” he and his coauthors noted.
An over-the-counter birth control pill would especially benefit adolescents, Cherie P. Dhar, MD, an assistant professor of pediatrics at the Northwestern University Feinberg School of Medicine, said in an interview. Like Grossman, Dhar spoke during the FDA advisory panel meeting’s public hearing, where she presented the views of the Society for Adolescent Health and Medicine’s Reproductive Health Committee, of which she is a member.
“There are less clinics that see teens,” she told JAMA. “They’re the ones who will go to a drug store and pick this up.” Barriers to obtaining prescription oral contraceptives include the need for transportation to an appointment and appointment availability and scheduling, Dhar and her fellow committee members wrote in a recent commentary.
Marginalized youth, such as members of sexual, gender, racial, or ethnic minority groups, face even greater obstacles in trying to see a health care professional, Dhar said. Indeed, a recent online cross-sectional survey of people who identified as American Indian or Alaska Native; Asian American, Native Hawaiian, or Pacific Islander; Black or African American; or Latina/Latinx found high interest in an over-the-counter oral contraceptive, particularly among those not currently using a contraceptive method. Nearly 9 in 10 of the respondents were between the ages of 18 and 34 years.
Just because a birth control pill becomes available without a prescription doesn’t mean that adolescents will never talk to a physician or a parent about it, but it would mean that young people would be able to obtain effective contraception in a more timely manner, Dhar said. “I think it’s going to be important for pediatricians to be able to talk about this.”
Will Cost Be an Obstacle?
Insurance doesn’t usually cover over-the-counter medications, raising questions about how much people would have to pay out of pocket for a nonprescription birth control pill.
“This is a great, huge step in access to contraceptives,” Dhar said. “I hope they make this pill affordable.”
The Affordable Care Act mandates that insurers cover without cost sharing the 2 types of emergency contraception, which are available over-the-counter, only if prescribed by an attending clinician, according to a guidance issued last July by the US Departments of Health and Human Services, Labor, and the Treasury. Insurers are “encouraged” but not required to cover emergency contraception bought without a prescription, the guidance noted.
“Although the availability of over-the-counter contraceptives can increase users’ independence and autonomy and improve access, there may also be disadvantages, such as higher out-of-pocket costs…,” World Health Organization scientists wrote in a 2022 article.
After the FDA advisory committees voted in favor of making the norgestrel pill available without a prescription, a group of women lawmakers in the US Senate and the US House reintroduced their Affordability is Access Act. The legislation would require that insurers cover the cost of over-the-counter birth control without any fees or out-of-pocket costs.
“We are here to make sure that when birth control is available to everyone over-the-counter, it is also affordable for everyone,” Sen Patty Murray (D, Washington), one of the bill’s sponsors, said at a press conference urging the FDA to approve Opill.
For now, whether private insurers must cover an over-the-counter birth control pill appears to depend on where the insured person lives. As of May 1, 12 states and the District of Columbia required that insurers cover over-the-counter contraceptives, although a handful of the states exclude male condoms, according to the Guttmacher Institute, a research and policy organization.
“It’s potentially a market of millions of people,” Grossman noted. “A lot of it has to do with what the price is and whether it’s covered by insurance.”
Published Online: May 31, 2023. doi:10.1001/jama.2023.9497
Conflict of Interest Disclosures: Dr Grossman reported serving as a steering committee member for the Free the Pill Coalition and receiving funding from Ibis Reproductive Health for research activities related to over-the-counter access to oral contraceptives. No other disclosures were reported.
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