Why it matters
The drug, called Opill, which was approved for over-the-counter sale by the Food and Drug Administration last year, will be the most effective birth control method without a prescription, research shows – more effective than condoms, spermicides and other over-the-counter methods.
Reproductive health experts said its availability could be particularly useful for teenagers, young women and others who have difficulty dealing with the time, cost or logistical hurdles associated with visiting a doctor to obtain a prescription.
Some experts said this could be a particularly good option for teenagers who might otherwise rely on condoms.
Lupe M. Rodriguez, executive director of the National Latina Institute for Reproductive Justice, said in a statement Monday that “over-the-counter access to contraception will significantly reduce barriers such as transportation, cost, language and documentation.”
Opill is not a new drug – it was approved for prescription use 50 years ago. Reproductive health experts and members of an FDA advisory panel noted the long history of safety and effectiveness. With typical use, it is 93 percent effective at preventing pregnancy. Women with certain medical conditions – especially breast cancer or undiagnosed vaginal bleeding – should not take Opill. But for most women, “the risk is very low and almost non-existent if they read and follow the label,” Karen Murry, deputy director of the FDA's Division of Non-Prescription Drugs, said in a memo explaining the approval decision .
Since the Supreme Court struck down the nation's right to abortion in 2022, contraceptive accessibility has become an increasingly pressing issue. But long before that, the move to make an over-the-counter pill available to all ages had received widespread support from reproductive and adolescent health specialists and groups.
Opill's approval faced little public opposition from conservative groups that are often critical of measures to improve access to abortion, emergency contraception and sex education. The resistance seemed to come primarily from some Catholic organizations and Students for Life Action.
In a 2022 survey by health research organization KFF, more than three-quarters of women of childbearing age said they prefer an over-the-counter pill, primarily because of convenience.
The details
Opill is called a “mini-pill” because it contains only one hormone, progestin, as opposed to “combination pills,” which contain both progestogen and estrogen. Cadence Health, a company that makes a combination pill, is also in discussions with the FDA about applying for over-the-counter status.
Perrigo said Monday that Opill was available for pre-order at some online retailers. A three-month supply of Opill is also sold by retailers at a price of $49.99. The company's website, Opill.com, also sells the three-month supply as well as a six-month supply for $89.99.
In its announcement, Perrigo said the company would offer a “cost assistance program” to “help qualified, uninsured, low-income individuals obtain Opill at little or no cost.”
What happens next
Making the pill affordable for all women remains a goal of reproductive health advocates, many of whom said Monday that the cost is prohibitive for some populations.
“As a high school student in Texas who struggled to take the pill under the current system and faced social stigma along the way, I know firsthand how important it is to make sure young people walk into a store and can easily access the contraceptives they need,” Maia Lopez, 17, a member of the nonprofit Advocates for Youth's FreeThePill Youth Council, said in a statement. “Although today is a great step forward, the price is still high for many teenagers I know.”
The Affordable Care Act requires health insurance companies to cover the cost of prescription contraceptives, but not over-the-counter methods. Some states have laws requiring coverage of over-the-counter contraceptives, but most do not.
The KFF survey found that 10 percent of women would be unable or unwilling to pay for contraceptives out of pocket. About 40 percent would pay $10 or less per month, and about a third would pay between $11 and $20.
Three Democratic senators – Patty Murray of Washington, Mazie Hirono of Hawaii and Catherine Cortez Masto of Nevada – issued a statement Monday calling for the passage of a law requiring insurers to cover over-the-counter contraceptives. They have also pushed the federal government to do something similar under an executive order signed by President Biden last year to improve access to contraceptives.
“The work doesn’t stop here – more needs to be done to ensure every American has access to and can afford the over-the-counter pill,” the senators said.