The U.S. Food and Drug Administration (FDA) has approved the country’s first over-the-counter daily oral contraceptive, prompting experts to question when Canadians can receive the same access.
The approved tablet called Opill contains the progestin norgestrel and will be available for purchase in the U.S. without a prescription from a health-care provider. The FDA said in a statement Thursday that the hormonal contraceptive is expected to be more effective than other over-the-counter contraceptive methods that are currently available, including condoms, in preventing unintended pregnancy.
Dr. Wendy Norman, who holds the Public Health Agency of Canada and the Canadian Institutes of Health Research Chair in Family Planning Public Health Research, says the FDA’s move is an “important decision.”
“I hope that Canada will similarly consider this next step that could improve access to contraception for people across our country,” she said.
Nonprescription birth control pills are not currently available in Canada, but Dr. Norman noted that the FDA’s decision is not unlike Canada’s approval for some progesterone-only emergency contraception pills.
Plan B contains 1.5 mg of the hormone levonorgestrel, which is another type of progestin. It’s available over the counter at most pharmacies.
The approved U.S. contraceptive is progestin-only, or a “mini pill,” meaning it is not combined with the hormone estrogen. Combination pills, which can carry a risk of blood clots and stroke for some, are not available over the counter in the U.S. or Canada and still require a prescription.
“This is really a transformation in access to contraceptive care,” said Kelly Blanchard, president of Ibis Reproductive Health, a non-profit group that supported the approval. “Hopefully this will help people overcome those barriers that exist now.”
Insiya Mankani, public affairs officer at Action Canada for Sexual Health and Rights, says any move that increases access to contraception is a step in the right direction. Still, there’s a lot to “wait and see” about with respect to the approval.
Mankani says she’ll be looking out for the cost of the product, which Ireland-based manufacturer Perrigo has not announced yet.
“We know in Canada, because we don’t have a national drug plan, one of the larger barriers for access to contraception is cost. A lot of people have to pay out of pocket for it, particularly if they don’t have it covered through their health insurance,” she explained.
“(Perrigo) has said it is affordable, but what does affordable mean?”
Over-the-counter medicines are generally cheaper than prescriptions, but they aren’t covered by insurance. British Columbia is the only province to offer universal coverage of prescription birth control, which can also be prescribed by pharmacists, and which Mankani says is another one of many ways the country can provide better access to Canadians.
“Essentially we want to see access expanded, whether that means people are getting this over the counter … or getting it covered,” Mankani says.
She notes that the FDA’s announcement also brings up a good question about who has the ability to prescribe in Canada.
“It doesn’t necessarily need to be an over-the-counter pill if your pharmacist can prescribe it, if your midwives can prescribe it… registered nurses,” she said.
“(Access) really does need to be expanded, and this is one of those ways.”
According to the FDA, Perrigo won’t start shipping the pill until early next year, and there will be no age restrictions on sales. The administration says Opill is safe and effective but should not be used by those who have or have ever had breast cancer. Consumers who have any other form of cancer should ask a doctor before use.
Hormonal birth control pills have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s. Until now, all of them required a prescription.
American medical societies and women’s health groups have pushed for wider access, noting that an estimated 45 per cent of the six million annual pregnancies in the U.S. are unintended. Teens and girls, women of color and those with low incomes report greater hurdles in getting prescriptions and picking them up.
Some of the challenges can include paying for a doctor’s visit, getting time off from work and finding child care.
The United Kingdom previously authorized a version of the progestin-only pill to be sold without a prescription at pharmacies after a consultation with a pharmacist in 2021.
– with files from The Associated Press
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