The first U.S. over-the-counter birth control pill will soon be available

Why it matters

The drug, called Opill, which was approved by the Food and Drug Administration last year for sale without a prescription, will be the most effective method of contraception available without a prescription, research shows — more effective than condoms, spermicides and other nonprescription drugs . methods.

Reproductive health experts said its availability could be especially helpful for teens, young women and others who struggle with the time, cost or logistical hurdles associated with visiting a doctor to get a prescription. to acquire.

Some experts said they thought this could be a particularly good option for teens, who might otherwise have to 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 cited the long history of safety and efficacy. With normal use, it is 93 percent effective in preventing pregnancy. Women with certain conditions – mainly breast cancer or undiagnosed vaginal bleeding – should not use Opill. But for most women, “the risk is very low and virtually nonexistent if they read and follow the labeling,” Karen Murry, deputy director of the FDA’s Office of Nonprescription Drugs, said in a memo explaining the approval decision.

Since the Supreme Court overturned the nation’s right to abortion in 2022, accessibility to contraception has become an increasingly pressing issue. But long before that, the move to make a pill available without a prescription to all ages had received widespread support from reproductive health and adolescent health specialists and groups.

Opill’s endorsement was met with very little public opposition from conservative groups who are often critical of measures increasing access to abortion, emergency contraception and sex education. The resistance seemed to come mainly from some Catholic organizations and Students for Life Action.

In a research in 2022 by healthcare research organization KFFMore than three-quarters of women of childbearing age said they preferred an over-the-counter pill, mainly because of convenience.

The details

Opill is known as a ‘minipill’ because it contains only one hormone, progestin, unlike ‘combination pills’, which contain both progestin 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 can be pre-ordered from some online retailers. A three-month pack of Opill will also be sold by retailers for a price of $49.99. The company’s website Opill.com will also sell the three-month pack, as well as a six-month supply that costs $89.99.

In the announcement, Perrigo said the company would offer a “cost assistance program” to “help qualified, uninsured, low-income individuals obtain Opill at low or no cost.”

What happens now

Making the pill affordable for all women remains a goal for reproductive health advocates, many of whom said Monday that the cost would be out of reach for some populations.

“As a high school student in Texas who struggled to access birth control under the current system and faced social stigma while trying, I know firsthand the importance of ensuring young people can enter a store can walk and easily access the contraception they need. Maia Lopez, 17, a member of the FreeThePill Youth Council at the nonprofit Advocates for Youth, said in a statement. “While today is a huge step forward, the price is still high for many teens I know.”

The Affordable Care Act requires health insurers to pay for prescription contraception, but not for over-the-counter methods. Some states have laws mandating coverage of over-the-counter contraception, but most states do not.

The KFF research found that 10 percent of women would not be able or willing to pay out-of-pocket costs for contraception. 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 urging passage of legislation to require insurers to cover over-the-counter contraception. They have also urged the federal government to do something similar under a executive order to increase access to contraception that President Biden issued signed last year.

“The work doesn’t stop here – more must be done to ensure that every American has access to the pill and can afford it without a prescription,” the senators said.