“Access to the over-the-counter pill is really about equity, and now more than ever, we must do everything in our power to break down barriers to contraception, knowing that access to the abortion is going to get a lot harder in this country,” said Raegan McDonald-Mosley, CEO of Power to Decide, a nonprofit that works to prevent unplanned pregnancies.
The prospect of having a daily birth control pill available anywhere people can buy drugs without a doctor’s supervision comes nearly two decades after a deadly battle at the FDA to make the emergency contraception drug known as of “Plan B” available over the counter – a political dispute that prompted the resignation of Susan Wood, director of the agency of the Office of Women’s Health.
“Reviewers and executives are under pressure from all sides, so it’s really important that any kind of protection around the FDA is in place and maintained and reinforced because it’s not perfect,” Wood said. , now a professor of health policy at George Washington University. .
Democratic lawmakers are pressuring the FDA to act quickly once applications are submitted. “The health and well-being of people capable of getting pregnant across America are at stake,” wrote 59 House members led by Pro-Choice Caucus chairs, FDA Commissioner Robert Califf, in March.
Meanwhile, some conservative lawmakers are working to restrict access to contraception, and Sen. Marsha Blackburn (R-Tenn.) questioned the legal precedent establishing the right to privacy for access to contraceptives during the nomination hearings for Supreme Court Justice Ketanji Brown Jackson.
A coalition of reproductive rights groups, researchers and clinicians have worked to bring hormonal contraceptives over the counter for nearly two decades. The Over-the-Counter Oral Contraceptive Task Force, which counts Wood as a member, began working with HRA Pharma in 2016 to conduct research to support an application for OTC designation.
Both the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians supported over-the-counter birth control pill options, which OTC advocates say makes it clear that the FDA can and should approve the change.
“I don’t think we would have gotten into this if we didn’t, and that should prompt the FDA to support it,” he said. Samantha Miller, co-CEO of Cadence Health.
Birth control pills, while extremely safe, can complicate some underlying health conditions and have always required a doctor’s supervision.
Some proponents say it will likely be easier to make HRAs over the counter, as it poses less risk to different groups of people. Hana is a progestin-only pill, which means there is less chance of side effects. Cadence makes a combination pill that contains a mixture of estrogen and progestin. People over 35, smokers, or those with poorly controlled high blood pressure or blood clotting disorders may be advised to avoid combination pills.
Both companies also need to make sure consumers can understand the label and follow the instructions that come with the drug.
A spokesperson for HRA Pharma declined to comment on the FDA process, but said the company is working to address women’s unmet medical needs.
“Expanding access to birth control and birth control options is an important part of health care,” the company said in a statement. “A safe and effective over-the-counter contraceptive pill would improve access and reduce some of the barriers people face in obtaining contraception.”
Miller said the FDA suspended real-use trials of Cadence’s combination pill, adding more requirements around blood pressure monitoring of trial participants. The new requirements, which required Cadence to update its label and redo comprehension studies, delayed the company’s real-use trial by at least a year, she said.
“We’re really committed to going all the way,” Miller told POLITICO.
Proponents also promote an OTC designation for the pills without limiting their use to adults. They argue that science shows birth control pills are safe and effective in teens, and any foray into age restrictions would politicize OTC change.
“I would be much more worried [people over 80] take something that could cause them harm than the under-15 crowd that takes a drug that you can’t overdose on, that has no adverse effects of any kind,” Wood said.
Proponents of over-the-counter birth control argue that removing barriers to oral contraceptives does not replace safe abortions, but provides one more tool for people to prevent unwanted pregnancies.
“Everyone should have the freedom to determine their own life path,” said Victoria Nichols, project manager for the Free the Pill campaign, which is associated with the OTC Pill Task Force. “Contraception and abortion are both part of the full range of sexual and reproductive health care that allows us to exercise this freedom.”
This story has been updated to include a statement from HRA.