The Food and Drug Administration on Thursday approved a birth control pill that can be sold without a prescription for the first time in the United States, a milestone that could significantly expand access to birth control.
The drug, called Opill, will become the most effective method of contraception available over the counter — more effective at preventing pregnancy than condoms, spermicides and other non-prescription methods. Reproductive health experts said its availability could be especially helpful for young women, teens and people who struggle with the time, cost or logistical hurdles associated with visiting a doctor to get a prescription .
The pill’s manufacturer, Dublin-based Perrigo Company, said Opill will most likely be available in stores and online retailers across the United States in early 2024.
The company didn’t say how much the medication would cost — an important question that will help determine how many people will take the pill — but Frédérique Welgryn, Perrigo’s global vice president for women’s health, said in a statement that the company was committed to making the pill “accessible and affordable to women and people of all ages.” Ms Welgryn has also said the company would have a consumer aid program to provide the pill for free 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, said in a statement. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available non-prescription methods of contraception in preventing unintended pregnancy.”
Since the Supreme Court overturned the national right to abortion last year, access to contraception has become an increasingly pressing issue. But long before that, the move to make a prescription-free pill available to all ages had gained widespread support from reproductive and adolescent health specialists and groups such as the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy or Family Physicians.
In a survey last year by the health research organization KFF, more than three-quarters of women of childbearing age said they preferred an over-the-counter pill primarily because of convenience. Nearly 40 percent said they would probably use it. Those most likely to choose the product included women already taking birth control pills, women without health insurance and Hispanic women, the study found.
And surprisingly, at a time of fierce division over abortion, many anti-abortion groups have refused to criticize over-the-counter contraception. The resistance seems to come mainly from some Catholic organizations and Students for Life Action.
In May, a panel of 17 independent FDA scientific advisers — including obstetrician-gynecologists, pediatrician specialists, a breast cancer specialist, and experts on consumer behavior and health literacy — voted unanimously that the benefits of making a birth control pill available without a prescription far outweighed the risks.
The panel cited the long history of safety and efficacy of Opill, which was approved for prescription use 50 years ago. The over-the-counter pill will be identical to the prescription version, which is 93 percent effective at preventing pregnancy when used normally.
Several panelists said there was an urgent 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 division of reproductive health at the Centers for Disease Control and Prevention.
She 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 over-the-counter birth control pills are available — meaning affordably priced and fully covered by insurance — they will be a game-changer for communities affected by systemic health inequalities,” said Dr. Daniel Grossman, director of Advancing New Standards in Reproductive Health, who has led research on over-the-counter birth control.
The Affordable Care Act requires health insurance to pay for prescription contraception, but not over-the-counter methods. Some states have laws requiring over-the-counter birth control coverage, but most states do not. The KFF survey found that 10 percent of women would be unable or unwilling to afford an out-of-pocket cost for birth control. About 40 percent would pay $10 or less per month, and about a third would pay $20 or less.
Under a recent executive order from President Biden, the federal government could soon take steps to require insurers to cover over-the-counter birth control. And Senate Democrats have reintroduced legislation requiring such coverage.
“We need to make it affordable and available,” Sen. Patty Murray, a Washington state Democrat and the bill’s lead sponsor, said in an interview in May. “Let’s give women what they need and make sure it’s affordable so there’s equality, and low-income women, women who are struggling for whatever reason, don’t have to be forced to go off birth control simply because they can’t.” pay it today,” she added.
Opill is known as a “mini-pill” because it contains only one hormone, progestin, unlike “combined pills,” which contain both progestin and estrogen. A company that makes a combination pill, Cadence Health, has also been in talks with the FDA about applying for over-the-counter status.
The FDA analysts who reviewed the data Perrigo submitted in its filing for a prescription-free Opill had raised concerns about whether women with medical conditions that should prevent them from taking birth control pills — primarily breast cancer and undiagnosed vaginal bleeding – would follow the warnings and the Product. The FDA analysts also questioned whether younger adolescents and people with limited literacy skills could follow the directions.
But in a memo explaining the approval decision on Thursday, Karen Murry, deputy director of the FDA’s Office of Over-the-Counter Drugs, wrote: “For an individual consumer of the product, the risk is very low and almost non-existent if they read the instructions. and follow up. tagging.”
“Overall,” she continued, “the overall public health impact of the potential harm associated with inappropriate use by people with progestin-sensitive cancers is likely to be outweighed by the likely greater public health impact of preventing a large number of unintended pregnancies with all their consequences.” associated damage.”
Several members of the advisory committee said patients with breast cancer, the leading medical condition preventing use of hormonal birth control, usually have doctors who would advise them to avoid birth control pills. They also said that Opill may be the safest for adolescents because they are very unlikely to develop breast cancer. And because young people often start using contraception that they can buy over the counter, it’s especially important for them to have easy access to a method that’s more effective than condoms and other contraceptive products available in stores, the panelists said.
Perrigo reported that study participants took Opill on 92.5 percent of the days they were supposed to take it. Most participants who missed a pill reported following label directions to take mitigating measures, such as abstaining from sex or using a condom, said Dr. Stephanie Sober, the company’s US medical liaison, at the advisory committee hearing. She said that of the 955 participants, only six became pregnant while taking Opill.
Most of the people who said they missed doses attributed it to the pills running out before they could get to any of the study supply locations. pill available without a prescription.
