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US approves first over-the-counter birth control pill


By BBC
Published : 14 Jul 2023 12:42 AM

The US government has approved the first-ever over-the-counter birth control pill.

The Food and Drug Administration announced on Thursday birth control pill Opill will be available without a prescription for women of all ages.

In a statement, the agency said the move would help reduce women's barriers to accessing contraception.

The manufacturer of Opill has said it will most likely be available over the counter in early 2024.

Doctors say that the progestin-only pill - often known as the "minipill" - is a particularly safe form of contraception because it does not contain oestrogen, meaning it has fewer side effects and health risks.

The most common side effects of Opill include irregular bleeding, headaches, dizziness and nausea. The contraception is also not recommended for women who have had breast cancer.

The US joins more than 100 countries around the world that have made the birth control pill available over the counter, including most countries in Latin America, as well as India, China and the United Kingdom.

"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," said DrPatriziaCavazzoni, director of the FDA's Center for Drug Evaluation and Research.

The approval comes after an FDA expert advisory panel in May unanimously voted to recommend the pill be available over the counter.

The panel found that Opill - first approved by the FDA in 1973 - had a history of safety and efficacy in preventing pregnancies.

During the hearing, some scientists had raised concerns about whether young people and those with limited literacy could understand how to properly take the pill, including not taking it at all if they have a history of breast cancer.

But some committee members concluded women with breast cancer were already likely to be in contact with their doctors and aware that they should not take hormonal contraception.

Experts say women - and in particular, teenagers - encounter a number of barriers to accessing reproductive health services, including a lack of health insurance and difficulty finding transportation to doctor's appointments.

Doctors and activists have argued making birth control available without a prescription will have a host of health benefits, including reducing unintended pregnancies.

In the US, some studies have found as many as nearly half of all pregnancies are unintended.

Some doctors told the BBC that more easily accessible birth control options were needed in the US, and something that became more of a consideration after the Supreme Court overturned Roe v Wade a little over a year ago.

"More and more people are considering what there options are knowing they may not be able to have access to an abortion. Having access to birth control, particularly ones you don't have to engage with health care system to get, is really important," said Dr Kristyn Brandi, with the American College of Obstetricians and Gynecologists.

It is unclear exactly how much Opill will cost at pharmacies, but the Biden administration said the manufacturer, Perrigo Company, will determine when the pill is available and for what price.

In a statement on Thursday, the drug manufacturer called the move a "groundbreaking expansion for women's health".

Advocates for Youth, a nonprofit organisation advocating for reproductive health rights, meanwhile, argued the approval was "long overdue".

"[W]e need to ensure young people have everything they need to lead healthy lives and plan their futures," said Debra Hauser, the organisation's president.