The Food and Drug Administration on Thursday approved the birth control pill to be sold without a prescription for the first time in the United States, a milestone that could significantly expand access to contraception.
the medicine, called Opill, will be the most effective form of birth control available over the counter — more effective at preventing pregnancy than condoms, spermicide and other over-the-counter methods. Reproductive health experts say its availability could be especially beneficial for young women, teenagers and those who find it difficult to deal with the time, cost or logistical hurdles involved in visiting a doctor to get one. prescription.
The pill’s manufacturer, the Perrigo Company, based in Dublin, said Opill will likely be available from stores and online retailers in the United States in early 2024.
The company did not say how much the drug costs — a key question that will help determine how many people will use the pill — but Frédérique Welgryn, Perrigo’s global vice president for women’s health, said in a statement that the company is committed to making the pill “accessible and affordable to women and men of all ages.” Ms. also said Welgryn said the company will have a consumer assistance program to provide the pill free of charge to some women.
“Today’s approval marks the first time that an over-the-counter, daily oral contraceptive will be an available option for millions of people in the United States,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”
Since the Supreme Court struck down national abortion rights last year, the accessibility of contraception has become an increasingly urgent issue. But even before that, the move to make an over-the-counter pill available for all ages received widespread support from reproductive and adolescent health specialists and groups like American Medical AssociationThe American College of Obstetricians and Gynecologists and the American Academy of Family Physicians.
In a survey last year by the healthcare research organization KFF, more than three-quarters of women of reproductive age said they favored an over-the-counter pill, mainly because of convenience. Almost 40 percent said they would probably use it. Those most likely to opt for the product include women who already take birth control pills, women without health insurance and Hispanic women, the survey found.
And notably, at a time of intense division over abortion, many anti-abortion groups have refused to criticize over-the-counter birth control. Opposition appears to be coming mainly from some Catholic organizations and Students for Life Action.
In May, a panel of 17 independent scientific advisors to the FDA – including obstetrician-gynecologists, adolescent medicine specialists, a breast cancer specialist and experts in consumer health behavior and health literacy – who unanimously voted that the benefits of making the birth control pill available without a prescription far outweighed the risks.
The panel noted the long history of safety and effectiveness of Opill, which was approved for prescription use 50 years ago. The over-the-counter pill will be the same as the prescription version, which is 93 percent effective at preventing pregnancy with typical use.
Several panelists said there is a pressing public health need for an over-the-counter option in a country where nearly half of all pregnancies are unintended.
“The evidence shows that the benefits clearly outweigh the risks,” said an advisory committee member, Kathryn Curtis, a health scientist in the Centers for Disease Control and Prevention’s division of reproductive health.
He added: “I think Opill has the potential to have a huge positive impact on public health.”
For proponents of over-the-counter pills, the main issue is affordability.
“If available fairly – meaning that they are affordable and fully covered by insurance – over-the-counter birth control pills will be a game-changer for communities affected by systemic health equity,” said Dr. Daniel Grossman, director of Advancing New Standards in Reproductive Health, who has led research on over-the-counter contraception.
The Affordable Care Act requires health insurance plans to pay for prescription contraception, but not over-the-counter methods. Some states have laws mandating coverage of over-the-counter birth control, but most states do not. The KFF survey found that 10 percent of women were unable or unwilling to pay any cost for contraception. About 40 percent would pay $10 or less per month, and about a third would pay $20 or less.
Under recent executive order by President Biden, the federal government may take steps toward requiring insurers to cover over-the-counter birth control. And Senate Democrats have reintroduced law to require such coverage.
“We have to make it affordable and available,” Senator Patty Murray, a Democrat from Washington State and a co-sponsor of the bill, said in an interview in May. “Let’s give women what they need and make sure it’s affordable to have equity, and low-income women, women who are struggling for whatever reason don’t have to be forced to go without any birth control just because they don’t they can. can afford now,” she added.
Opill is known as a “mini pill” because it contains only one hormone, progestin, as opposed to “combination” pills, which contain both progestin and estrogen. A company that makes a combination pill, Cadence Health, has also talked to the FDA about applying for over-the-counter status.
FDA analysts who reviewed data submitted by Perrigo in its application for a non-prescription Opill raised concerns about whether women with medical conditions that should prevent them from taking the pills for contraception – mainly breast cancer and undiagnosed vaginal bleeding – will follow the warnings and avoid the product. FDA analysts also questioned whether younger teens and people with limited literacy could follow the directions.
Some members of the advisory committee said that patients with breast cancer, the main medical condition that precludes taking hormonal contraception, usually have doctors who advise them to avoid birth control pills. They also say that Opill may actually be safest for young people because they are very unlikely to get breast cancer. And since young people often start with contraception that they can buy over-the-counter, it is especially important for them to have easy access to a method that is more effective than condoms and other products. of birth control available in retail stores, the panelists said.
Perrigo reported that participants in one study took Opill on 92.5 percent of the days they were supposed to take it. Most participants who missed a pill reported that they followed label directions to take mitigation measures, such as abstaining from sex or using condoms, Dr. Stephanie Sober, the company’s US medical liaison, at the advisory committee hearing. He said that out of 955 participants, only six became pregnant while using Opill.
Most of the people who said they missed doses attributed that to running out of pills before they got to one of the study’s resupply sites, which resulted, Dr. the pill is available over the counter.