US approves first over-the-counter birth control pill

The US Food and Drug Administration (FDA) has approved the sale of over-the-counter birth control pills in the United States for the first time. This could greatly expand access to contraceptives. Writes about it The New York Times.

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The drug, called Opill, will become the most effective birth control method available without a prescription—more effective at preventing pregnancy than condoms, spermicides, and other over-the-counter methods.

Study participants took Opill for 92,5% of the days they were supposed to take it. The majority of participants who missed a pill reported that they followed the directions on the label and took remedial action, such as abstaining from sex or using a condom. Among the 955 participants in the experiment, only six became pregnant while using Opill.

Reproductive health experts say its availability can be especially helpful for young women, teens, and those who find it difficult to cope with the time, cost, or logistical challenges of going to the doctor to get a prescription.

Pill maker Perrigo Company, based in Dublin, Ireland, said Opill will likely hit U.S. stores and online stores in early 2024.

The company did not say how much the drug would cost, a key question that will help determine how many people will use the pills. But Frederick Welgreen, Perrigo's global vice president of women's health, said the company is committed to doing everything it can to make the pill "accessible and affordable for women and people of all ages."

Velgreen also said the company will have a consumer assistance program to provide free pills to some women.

"Today's approval marks the first time that over-the-counter oral contraceptives will be an affordable option for millions of people in the United States," Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a statement. “When used as directed, oral contraception is safe and is expected to be more effective than currently available over-the-counter methods of contraception in preventing unintended pregnancy.”

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Since the Supreme Court struck down the nation's right to abortion last year, access to contraception has become an increasingly pressing issue. But long before that, the proposal to make over-the-counter pills available to all ages had received widespread support from reproductive and adolescent health experts, as well as groups such as the American Medical Association (AMA), the American College of Obstetricians and Gynecologists. College of Obstetricians and Gynecologists (ACOG) and American Academy of Family Physicians (AAFP)

In a 2022 survey by health research organization KFF, more than three-quarters of women of reproductive age said they preferred over-the-counter pills primarily because of convenience. Nearly 40% said they were most likely to use them. The survey showed that among those most likely to choose this product were women already taking birth control pills and women without health insurance.

And, surprisingly, in a time of bitter controversy over abortion, many anti-abortion groups refused to criticize over-the-counter birth control. Opposition seems to come mainly from some Catholic organizations and Students for Life.

In May, a panel of 17 FDA independent scientific advisors—including OB/GYNs, adolescent medicine specialists, a breast cancer specialist, and experts in consumer behavior and health literacy—voted unanimously that the benefits of selling over-the-counter birth control pills far outweighed risks.

The group cited Opill's long history of safety and efficacy, which was approved for prescription use 50 years ago. The over-the-counter tablet will be identical to the prescription version, which is 93% effective in preventing pregnancy with normal use.

Several panellists said there was a public health need for an over-the-counter option in a country where almost half of all pregnancies are unplanned.

For proponents of over-the-counter pills, the main concern is affordability.

“For them to be available fairly — they need to be affordable and fully covered by insurance — over-the-counter birth control pills 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 led research into over-the-counter contraception.

ObamaCare requires health insurance plans to cover the cost of prescription birth control, but OTC is not mentioned. Some states have laws requiring coverage for over-the-counter birth control, but most states do not. The survey showed that 10% of women are unable or unwilling to pay out of pocket for contraceptives. About 40% are willing to pay $10 or less per month, and about a third are willing to pay $20 or less.

Under a recent executive order by US President Joe Biden, the federal government may soon take steps to require insurance companies to cover OTC contraceptives. And Senate Democrats have again introduced a bill requiring such coverage.

“We have to make this drug available,” Sen. Patty Murray, a Washington 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.”

Opill is known as a "mini pill" because it contains only one hormone, progestin, as opposed to "combination" pills, which contain progestin and estrogen. Combination pill maker Cadence Health is also in talks with the FDA to apply for OTC status.

Analysts who evaluated the data presented by Perrigo in its application for the OTC drug Opill raised concerns about whether women with conditions that should prevent birth control pills - most notably breast cancer and undiagnosed vaginal bleeding - would follow the warnings. and avoid the product.

They also raised the question of whether teenagers and people with limited literacy would be able to follow directions.

Karen Murry, deputy director of the FDA's OTC division, said: "For the individual consumer, the risk is very low and almost non-existent if they read the label and do it right."

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Several advisory committee members said contraindications to birth control pills would not be an issue. The main disease for which hormonal contraceptives cannot be taken is breast cancer. But patients with this diagnosis already have a doctor who will tell them that hormonal drugs are dangerous for them.

They also said that Opill may actually be the safest for teens because they have very little chance of getting breast cancer. And because young people often start with birth control that they can buy without a prescription, it's especially important for them to have easy access to a method that's more effective than condoms and other birth control options available without a prescription.

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