The first over-the-counter birth control pill receives FDA approval in the US
US officials have approved the first over-the-counter birth control pill, allowing American women and girls to purchase contraceptives in the same aisle as aspirin and eye drops.
The Food and Drug Administration (FDA) said Thursday it has approved the sale of Perrigo’s once-daily Opill over-the-counter, making it the first such medication to be removed from behind-the-counter pharmacies. The company won’t begin shipping the pill until early next year, and there will be no age restrictions on sales.
Hormone-based pills have long been the most common form of birth control in the US and have been used by tens of millions of women since the 1960s. Until now, they all required a prescription.
Medical associations and women’s health groups have pushed for wider access, noting that an estimated 45 percent of the six million annual pregnancies in the US are unintended. Teens and girls, women of color, and those on low incomes report greater hurdles in getting and picking up prescriptions.
Some of the challenges may include paying for a doctor’s visit, getting time off from work, and finding childcare.
“This is truly a transformation in access to contraceptive care,” said Kelly Blanchard, president of Ibis Reproductive Health, a nonprofit that supported the approval. “Hopefully this will help people overcome the barriers that exist now.”
Ireland-based Perrigo has not disclosed a price. Over-the-counter drugs are generally much cheaper than prescription drugs, but they are not covered by insurance.
Many common medications have made the transition to over-the-counter status in recent decades, including medications for pain, heartburn, and allergies.
Perrigo submitted years of research to the FDA to show that women could understand and follow the instructions for using the pill.
Beginning April 1, British Columbia will offer residents free prescription contraception. Andrew Chang is accompanied by Dr. Ruth Habte, an OB-GYN resident, to discuss whether the rest of Canada will follow suit.
Some FDA scientists were concerned about the pill
Thursday’s approval came despite some concerns from FDA scientists about the company’s results, including whether women with certain underlying medical conditions would understand they shouldn’t take the drug.
The FDA’s action only applies to Opill. It’s in an older class of contraceptives, known as minipills, that contain a single
synthetic hormone and generally have fewer side effects than the more popular combination hormone pills.
But women’s health advocates hope the decision will pave the way for more over-the-counter birth control options and eventually abortion pills to do the same.
That said, the FDA’s decision has nothing to do with the ongoing lawsuits over the abortion pill mifepristone. The studies in Perrigo’s FDA filing began years before the Supreme Court reversed Roe v. Wade, upending access to abortion in the US
With some states restricting women’s reproductive rights, the FDA has faced pressure from Democratic politicians, health advocates and medical professionals to ease access to birth control.
The American Medical Association and the leading professional association of obstetricians and gynecologists supported Opill’s application for over-the-counter status.
An outside panel of FDA advisers voted unanimously for the move at a hearing in May, where dozens of public speakers called for Opill’s approval.
Dyvia Huitron was among those in attendance, explaining how she was unable to obtain prescription contraception for more than three years after becoming sexually active.
The 19-year-old University of Alabama student said she still doesn’t feel comfortable getting a prescription because the school’s health system reports medical exams and medications to parents.
“My parents wouldn’t let me go on the pill,” Huitron said in a recent interview. “There was just a lot of cultural stigma around being sexually active before getting married.”
Kate Kelly, of the advocacy group Shout Your Abortion, says multiple groups across the US are working to educate people about the availability of abortion medications after Roe v. Wade was overturned.
Although she uses other forms of birth control, “I would have much preferred birth control and used these additional methods to make sure I was as safe as possible.”
Huitron spoke on behalf of Advocates for Youth, one of dozens of groups working to make prescription contraceptives more accessible.
The groups helped fund some of the studies submitted for Opill and encouraged HRA Pharma, later acquired by Perrigo, to submit its application to the FDA.
‘Large’ amount of data shows that the pill is safe to use without a prescription
Lawyers were particularly interested in Opill because it raised fewer security concerns. The pill was first approved in the US five decades ago, but has not been marketed there since 2005.
“It’s been around for a long time and we have a large amount of data supporting that this pill is safe and effective for over-the-counter use,” says Blanchard of Ibsis Reproductive Health.
Newer birth control pills usually combine two hormones, estrogen and progestin, which can help make periods lighter and more regular. But their use carries an increased risk of blood clots and they should not be used by women who are at risk for heart problems, such as women who smoke and are over 35 years old.
Opill only has progestin, which prevents pregnancy by preventing sperm from reaching the cervix. It should be taken around the same time daily to be most effective.
In its internal review published in May, the FDA noted that some of the women in Perrigo’s study had difficulty understanding the drug’s labeling information.
In particular, the instructions warn that women with a history of breast cancer should not take the pill because it can stimulate tumor growth. And women who have unusual vaginal bleeding are instructed to talk to a doctor first, as this could indicate a medical problem.
Perrigo executives said the company will spend the rest of the year manufacturing the pill and packaging so that it will be available nationwide and online early next year.
