Here’s what doctors have to say about it.
After decades, the Food and Drug Administration finally approved the first-ever over-the-counter birth control pill on Thursday, expanding access to millions of Americans and helping them save on often-costly doctor visits. While the news has been cause for celebration for some, there’s also been pushback within the medical community.
Even though groups like the American Medical Association have applauded the FDA’s decision, some scientists and religious organizations, including the Alliance Defending Freedom, have raised concerns about the pill’s safety and effectiveness. “We continue to call upon the FDA to put the health and safety of women and girls first, put science and good medicine over politics, and follow the law,” Denise Harle, senior counsel with ADF, told Newsweek.
But doctors (and the FDA) still say the benefits far outweigh any potential risks. “The biggest gain is for underserved women who can’t afford the cost of even a clinic visit,” says Maria Sophocles, MD. “And I’m hopeful that the cost will be able to provide affordable access, not just access.”
After all, this expansion couldn’t come at a more crucial time as women increasingly struggle to access reproductive health care. A recent study showed that it has become harder for women to access reproductive health care services more broadly — such as routine screenings and birth control — in recent years. According to a study published Monday in JAMA Network Open, about 45 percent of women experienced at least one barrier to reproductive health care services in 2021, up 10 percent from 2017.
Here’s what we know about this major development and what doctors are saying about it.
What is Opill?
Opill, also known as the “minipill,” is a daily oral contraceptive that only uses the hormone progestin. This is a marked difference from other common forms of contraception, like combination birth control pills, which use the female sex hormone estrogen.
While a combined pill contains two hormones and stops the ovaries from releasing an egg each month, a progestogen-only pill, like Opill, has only one hormone, and it works by thickening cervical mucus and disrupting ovarian activity.
But just how effective are they? According to the Centers for Disease Control Control and Prevention, progestin-only pills are about 93 percent effective at preventing pregnancy. That said, Daniel Grossman, MD, tells us, it’s important to remember to take your pills consistently. “If you take it three hours late, that counts as a missed pill, and you need to use backup until you’re been back on the pill for a couple more days,” he says.
The mist efficient part is that users don’t even have to schedule a doctor’s visit to get their hands on them. Starting in 2024, these pills will be available without a prescription at drug stores like CVS, convenience stores, grocery stores, and online.
Why is over-the-counter birth control only now getting approved?
Opill, which is sold by the pharmaceutical giant Perrigo, was first approved for prescription use in 1973. Though there has been a decades-old campaign to expand it to be available over the counter, the FDA didn’t get moving until last year, following pressure from the White House and Supreme Court’s decision to overturn Roe v. Wade.
Then, this May, two of the agency’s independent panels voted unanimously to recommend the approval of Opill without a prescription. Data from a study by Perrigo showed that the majority of its nearly 900 participants used the drug properly even without a doctor’s guidance — they took the pill at the same time every day, as recommended, or used an alternative form of birth control if they’d missed their window.
During the review, some FDA scientists expressed concern that the study of what was by then a nearly 50-year-old drug could’ve been based on old data, or perhaps could include participants who double-dosed on the pill. But the experts we spoke to pushed back against these worries.
Dr. Grossman pointed out that Perrigo conducted the study responsibly by omitting participants who reported extra dosing. “The data is really good, so I’m not concerned about this,” he said. “All the evidence showed that people could follow the instructions and use the product safely and effectively.”
But there is still the possibility of other less-than-ideal implications of the switch to over-the-counter birth control. Dr. Sophocles emphasized that those who use it still need to regularly go into their doctor’s office for cancer screenings and tests for sexually transmitted diseases. “I don’t want a negative fallout from this to be an increase in STIs or an increase in undiagnosed cancers,” she tells us.
Are there any side effects?
As with any drug, unfortunately, there are side effects.
According to the FDA, the most common side effects are headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, or bloating. Though groups like the National Catholic Bioethics Center have opposed the pill over symptoms such as irregular bleeding, Dr. Grossman says it’s “a common side effect with progestin-only pills — but it’s not dangerous.” Both Dr. Grossman and Dr. Sophocles say using the pill can affect your regular period, with some people not having one at all.
And the FDA warns that you shouldn’t use Opill if you have or have ever had breast cancer. (You should also consult your doctor before using Opill if you’ve had any other forms of cancer.) And the medication isn’t recommended to be used alongside another hormonal birth control product, such as oral contraceptive tablets, a vaginal ring, a contraceptive patch, a contraceptive implant, a contraceptive injection, or an IUD.
What’s next?
One big question that remains is how much Opill might cost, and whether insurance will cover it. Though Perrigo is completely in charge of setting the price, the drugmaker has vowed to keep costs low — but it’s as-yet unclear what figure they’ll land on.
“It’s great that this has been approved by the FDA, but if it’s not available at an accessible price and ideally covered by insurance, then the people who most need it won’t be able to access it,” Dr. Grossman says.
But it also might not be the only option in the future. The drugmaker Cadence OTC is currently working on getting FDA approval for another kind of daily oral contraceptive — a combined estrogen and progestin pill. The hope is that it’ll eventually become available for over-the-counter sale, but the company doesn’t expect to begin final testing on the pill until next year.
“This is going to open the door to other over-the-counter contraceptives, and I’m hoping that soon we’ll see an application move forward for an over-the-counter combined hormonal pill,” Dr. Grossman says. “These combined pills are actually much more commonly used by women in the U.S.”
