A drug company is seeking U.S. approval for the first-ever oral contraceptive that women could buy without a prescription.
The Food and Drug Administration got one step closer to making birth control pills available over the counter when a panel of experts voted unanimously to recommend the move last week. At a time of increasingly fraught access to reproductive health care, being able to get birth control without a prescription would make it easier for people to plan and prevent pregnancies nationwide.
But Democratic lawmakers want to make it even more accessible, ensuring that health insurers provide no-cost coverage of oral contraceptives by passing the Affordability Is Access Act.
Sen. Patty Murray (D-Wash.) and Rep. Ayanna Pressley (D-Mass.) are expected to reintroduce the legislation Thursday, after first putting it forward last year.
The FDA is set to announce its decision on whether to reclassify the drug this summer.
“We want to make it very clear that, if the FDA approves this — which I hope that they do — that women will not only have access to it, but that they can afford it,” Murray told HuffPost on Wednesday. “We have to do everything we can to make sure women can make their own health care choices.”
Pressley pointed to some of the factors that can keep people from obtaining contraception: transportation, affordable child care, a regular doctor who takes their insurance, and having health insurance to begin with.
Expanding access as much as possible would be “life-changing for millions,” she said.
Co-leading the measure are Reps. Alexandria Ocasio-Cortez (D-N.Y.) and Ami Bera (D-Calif.), as well as Sens. Mazie Hirono (D-Hawaii) and Catherine Cortez Masto (D-Nev.).
HRA Pharma, a Paris-based division of drugmaker Perrigo, began the process of asking the FDA to approve over-the-counter sales of the birth control Opill in the summer of 2022.
Opill is a progestin-only birth control first approved by the FDA in 1973. (Other kinds of birth control pills contain an additional hormone, estrogen.) A progestin-only pill can be a good option for people who experience side effects with certain types of oral contraceptives. It is highly effective — more so than condoms — yet less effective than implanted birth control devices, according to the FDA.
The company has not yet said how much the drug would cost when obtained over the counter without insurance coverage.
Major medical groups including the American College of Obstetricians and Gynecologists and the American Medical Association support making oral contraceptives available over the counter.
But some FDA experts have expressed concerns over reclassifying them.
Over two days last week, an FDA panel held hearings to discuss the move, including data provided by the manufacturer that was deemed flawed. (Certain study participants returned “improbable” tracking diaries, saying they took more pills than they were given.)
Some also questioned whether teens and adult women could be relied upon to correctly administer the drug to themselves, remembering to take it at the same time every day and avoiding it if they had certain preexisting health conditions.
“I was kind of stunned that they said things like that, frankly,” Murray told HuffPost.
“We can’t trust women to take a pill at the same time? Oh, my God, talk to any woman. You know how we all manage our lives in many ways — we certainly know how to take medication,” she said.
“We certainly should be trusted with our own bodies,” Pressley added.
Proponents argue that five decades’ worth of use also clearly points to Opill’s safety.
One member of the panel, Dr. Katalin Roth, a medical professor at George Washington University, told The Washington Post that any reservations she had were outweighed by concern over the barriers that some women face in obtaining contraception.
“We know there’s a need,” Roth told the Post.
Polling indicates that likely Democratic and Republican voters support making oral contraceptives available over the counter by a wide margin: 71% said they were for it in a survey conducted last year by the Contraceptive Access Initiative, a nonprofit advocacy group.
Yet with the House in Republican hands, led by Speaker Kevin McCarthy (R-Calif.), the Democrats’ proposal to expand access by eliminating cost barriers faces a difficult path to becoming law.
“It’s an uphill battle, of course, but you don’t win a battle by going, ‘Oh, that’s too hard,’” said Murray, who led the effort to make Plan B emergency contraceptives available over the counter alongside then-Sen. Hillary Clinton (D-N.Y.) in the 2000s.
She sees clear parallels between that fight and the current push for over-the-counter birth control.
“It’s the same game,” she said, noting how the FDA feared conservative backlash to its Plan B decision nearly two decades ago.
Nowadays, conservatives appear to be using every last tool at their disposal to attack reproductive health care.
“They’re unrelenting. They’re exhaustive,” Pressley said. “And so we have to be the same, using every lever at our own disposal to protect and expand access to affordable over-the-counter contraception.”
When it became law in 2010, the Affordable Care Act said insurance companies had to provide no-cost access to birth control, although it carved out exemptions for certain religious groups. That rule still stands, but Mara Gandal-Powers, senior counselor for the National Women’s Law Center nonprofit, told HuffPost that there are other complicating factors.
Currently, insurers may still require a prescription to provide coverage for birth control pills, even though it’s not medically necessary; the Affordability is Access Act would change that.
The Supreme Court also threw a wrench into birth control access with its 2014 decision in Burwell v. Hobby Lobby Stores, which said that “closely held” for-profit corporations could also claim religious exemptions. Donald Trump’s presidential administration then “drove a Mack truck” through the situation by allowing “virtually any entity” to claim a religious or moral exemption, Gandal-Powers said.
President Joe Biden’s administration is now in the process of rolling back some of Trump’s changes while reminding insurers of their legal obligations.