The US Food and Drug Administration (FDA) has approved the first over-the-counter contraceptive pill, allowing millions of women and girls in the country to buy contraception without a prescription at a time when some states have sought to restrict access to birth control and abortion.
FDA officials said on Thursday it cleared Perrigo’s Opill – an every day, prescription-only hormonal contraception first approved in 1973 – to be sold over-the-counter. The pill will be available in stores and online in the first quarter of next year, and there will be no age restrictions on sales. The regulatory approval paves the way for people to purchase the pill” without a prescription for the first time since oral contraceptives became widely available in the 1960s.
“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” Patrizia Cavazzoni, the 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 nonprescription contraceptive methods in preventing unintended pregnancy.”
Most oral contraceptives are exceedingly safe, using a combination of estrogen and progestin to prevent pregnancy. Opill uses only progestin, and can be used even by people with a history of blood clotting or uncontrolled high blood pressure, according to the American College of Obstetricians and Gynecologists (ACOG).
However, the “mini-pill”, as some progestin-only contraceptives are called, also has side effects. The FDA on Thursday said the pill’s most common side effects include “irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating”.
A group of advisers to the FDA recommended in May that Opill be approved for over-the-counter use, despite concerns the agency raised about data Perrigo submitted with its application, including a study indicating that users may have taken more pills than they were supposed to. The experts advising the FDA concluded those risks were minimal compared to the significant benefits of making Opill available, and that its safety had been established for decades.
Presently, all hormonal daily birth control pills require a prescription in the US, and many are covered by health insurance. However, obtaining such a prescription has been difficult for many women. Roughly one in four US women who had ever attempted to get a hormonal birth control prescription reported difficulty doing so, often because of language barriers, lack of insurance or cost, according to a 2015 study. Teenagers and girls, women of colour and those with low incomes report greater hurdles in getting hold of prescriptions.
Medical societies and women’s health groups have for years called for birth control to be available over the counter, noting that nearly half of pregnancies in the US are unintended. The push intensified last year after the supreme court ended federal protection for abortion rights, throwing into question the future of birth control.
The pill’s manufacturer, Perrigo, which has its headquarters in Dublin, called the FDA’s approval a “milestone” and a “giant leap for women’s empowerment ” in a statement. The suggested retail price is expected to be announced this fall.
Health advocacy groups applauded the FDA’s decision, with many saying that the next step is ensuring coverage. Under the Affordable Care Act, insurance companies are required to cover women’s preventative services, including birth control, but not over-the-counter methods. Frederique Welgryn, Perrigo’s global vice president for women’s health, said the company is “committed to ensuring that Opill is affordable and accessible to people who need it.”
“If this is implemented correctly, expanding access to birth control will allow our communities the freedom to make meaningful decisions about our lives and futures,” said Lupe M Rodríguez, executive director at the National Latina Institute for Reproductive Justice. “Now we must ensure that this safe and effective birth control pill is affordable and covered by insurance.”
Under a recent executive order by Joe Biden, the federal government could soon take steps towards requiring health insurers to cover all contraceptives approved by the FDA.
“For the first time ever, women in this country will be able to walk into a pharmacy and pick up birth control without a prescription. But it’s not enough for an over-the-counter birth control pill to be available to women – it has to be affordable, too,” Senator Patty Murray, a Democrat from Washington State and the lead sponsor of the bill, said in a statement.
The pill’s approval comes at a landmark moment when states across the country have passed a raft of anti-abortion laws since the supreme court overturned Roe v Wade last year. A number of states, including a swath of the southern US, have passed full bans on abortion without exceptions for cases of rape or incest. On Tuesday, Iowa’s state legislature voted to ban most abortions after around six weeks of pregnancy, a time before most people know they are pregnant.
“Amidst the current reproductive health crisis, today’s news is positive,” the ACOG said in a statement. “We know that birth control is not a solution to abortion bans, as people need abortion care for many reasons.
“However, by increasing access to birth control through over-the-counter oral contraception, we have an opportunity to empower more people to control their own reproductive futures.”