FDA Approves First US Over-the-Counter Pill

Food and Drug Administration on Thursday approve birth control pills for sale without a doctor's prescription for the first time in the United States, a milestone that could significantly expand access to contraception.

The drug, called Opill, would become the most effective method of birth control available without a prescription — more effective at preventing pregnancy than condoms, spermicides, and other over-the-counter methods. Reproductive health experts say their availability can be particularly useful for young women, adolescents and those who have difficulty dealing with the time, cost or logistical constraints involved in visiting the doctor to get a prescription.

Pill manufacturer, Perrigo Company, based in Dublin, said Opill will most likely be available in stores and online retailers in the United States in early 2024.

The company didn't say how much treatment would cost – a key 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 is committed to making the pill “accessible and affordable to women.” and people of all ages.” Ms Welgryn also said the company would have a consumer assistance program in place to provide free pills to some women.

“Today's approval marks the first time that non-prescription daily oral contraceptives will become 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 contraceptives are safe and expected to be more effective than currently available over-the-counter methods of contraception in preventing unintended pregnancies.”

Since the Supreme Court revoked the national abortion right last year, the accessibility of contraception has become an increasingly pressing issue. But long before that, the move to make the over-the-counter pill available to all ages had widespread support from reproductive and adolescent health specialists and groups such as American Medical AssociationThat American College of Obstetricians and Gynecologists And American Academy of Family Physicians.

In a last year's survey by the health care research organization KFF, more than three-quarters of women of childbearing age say they like the over-the-counter pill, primarily because of convenience. Nearly 40 percent said they would likely use it. Those most likely to choose the product include women who are already taking birth control pills, women without health insurance and Hispanic women, the survey found.

And surprisingly, at a time of bitter division over abortion, many anti-abortion groups refuse to criticize over-the-counter contraceptives. Opposition seems to have come mainly from some Catholic organizations and Student for Life Action.

In May, a panel of 17 independent scientific advisers to the FDA — including obstetricians-gynecologists, adolescent medicine specialists, breast cancer specialists, and experts in consumer health behavior and health literacy — unanimously decided that the benefits of making birth control pills available without prescription far outweighs the risk.

The panel cited Opill's long history of safety and efficacy, 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 with regular use.

Some panelists said there was an urgent public health need for over-the-counter options in a country where nearly half of all pregnancies are unintended.

“The evidence shows that the benefits clearly outweigh the risks,” said one member of the advisory committee, 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 very positive public health impact.”

For over-the-top pill advocates, the main issue is affordability.

“If equitably available – meaning affordable and fully covered by insurance – over-the-counter birth control pills will be a game changer for societies impacted by systemic health inequities,” said Dr. Daniel Grossman, director of Advancing New Standards in Reproductive Health, who has led research on over-the-counter contraceptives.

The Affordable Care Act requires health insurance plans to pay for prescription contraception, but not over-the-counter methods. Some states have laws mandating over-the-counter contraceptive coverage, but most states don't. That KFF survey found that 10 percent of women would not be able or willing to pay for any form of contraception. About 40 percent will pay $10 or less per month, and about a third will pay $20 or less.

Under recently executive order by President Biden, the federal government could soon take steps to require insurance companies to cover over-the-counter birth control. And the Senate Democrats have the law was reintroduced to require such coverage.

“We need to make it affordable and available,” said Sen. Patty Murray, a Washington State Democrat and the bill's main sponsor, said in an interview in May. “Let's give women what they need and make sure it's affordable so there's justice, and low-income women, women who are struggling for whatever reason don't have to be forced not to have family planning just because they can't. bought it today,” he added.

The opill is known as the “mini pill” because it contains only one hormone, the progestin, as opposed to the “combination” pill, which contains both progestin and estrogen. A company that makes combination pills, Cadence Health, has also been in discussions with the FDA about its over-the-counter status.

FDA analysts evaluating the data Perrigo submitted in her application for over-the-counter Opill have raised concerns about whether women with medical conditions that should prevent them from taking birth control pills — particularly breast cancer and undiagnosed vaginal bleeding — will follow the warnings and avoid the product. FDA analysts are also raising questions about whether younger teens and people with limited reading abilities can follow the directive.

But in a memo explaining the approval decision on Thursday, Karen Murry, deputy director of the FDA's office of nonprescription drugs, wrote, “For individual consumers of the product, the risk is extremely low, and almost non-existent if they read and follow the guidelines. labeling.”

“Overall,” he continued, “the total public health impact of potential harm associated with misuse by people with progestin-sensitive cancers is likely to outweigh the likely public health impact of preventing a large number of unintended pregnancies.” in all their ways. officer loss.”

Several members of the advisory committee said patients with breast cancer, a major medical condition that precludes taking hormonal contraceptives, usually have doctors who will advise them to avoid birth control pills. They also say that Opill is actually safest for teenagers because they are very less likely to get breast cancer. And because young people often start with contraceptives they can buy without a prescription, it is especially important for them to have easy access to methods that are more effective than condoms and other contraceptive products available in retail stores, said the panelists.

Perrigo reports that participants in one study used Opill 92.5 percent of the days they should have used it. Most of the participants who missed the pill reported that they had followed label directions for taking mitigation steps, such as not having sex or using condoms, said Dr. Stephanie Sober, the company's US medical liaison, at an advisory committee meeting. He said that among the 955 participants, only six became pregnant while taking Opill.

Most people who say they've missed a dose attribute it to running out of pills before they could get to one of the study supply points, a result that, says Dr. Sober, “described precisely the barriers to adherence that could be reduced” by making the pill available over the counter.