The draft opinion on abortion renews the urgency on over-the-counter birth control
“Access to the over-the-counter pill is really a question of fairness, and now more than ever we must do everything in our power to break down barriers to contraception, knowing that access to abortion will become much more difficult in this one. nation, “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 wherever people can buy medicines without a doctor’s supervision comes nearly two decades after a tough battle at the FDA to make the emergency contraceptive drug known as “Plan B” available over the counter – a quarrel. policy that prompted the resignation of Susan Wood, director of the women’s health agency.
“The auditors and the leadership are under pressure from all directions, so it’s really important that any kind of protection around the FDA is in place and maintained and enforced because it’s not perfect,” said Wood, now a professor of health policy at George. Washington University.
Democratic lawmakers are pressuring the FDA to move quickly once applications are submitted. “The health and well-being of pregnant people across America is at stake,” FDA Commissioner Robert Califf, 59 House members led by presidents of the Pro-Choice Caucus, wrote in March.
Meanwhile, some conservative lawmakers are working to restrict access to contraception as well Sen. Marsha Blackburn (R-Tenn.) Questioned the legal precedent establishing the right to privacy for access to contraceptives during the hearings for the appointment of Supreme Court Justice Ketanji Brown Jackson.
A coalition of reproductive rights groups, researchers and doctors have been working to bring over-the-counter hormonal contraceptives for nearly two decades. The OTC Oral Contraceptive Working Group, which counts Wood as a member, began partnering with HRA Pharma in 2016 to conduct research in support of an OTC designation application.
The American College of Obstetricians and Gynecologists and the American Academy of Family Physicians have supported over-the-counter birth control pill options, which OTC advocates say the FDA can and should approve the switch.
“I don’t think we would have embarked on this if it hadn’t, and that should sway the FDA to back it up,” 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 advocates say it will likely be easier to do over-the-counter HRA because it poses less risk to different groups of people. Hana is a progestogen-only pill, which means there is less chance of adverse reactions. Cadence makes a combination pill that contains a mix of estrogen and a progestin. People over the age of 35, smokers or those who have high blood pressure or poorly controlled blood clotting disorders may be advised to avoid combination pills.
Both companies must also ensure that consumers can understand the label and follow the directions that accompany the drug.
A spokesperson for HRA Pharma declined to comment. But Miller said the FDA has placed a clinical hold on studies of actual use of Cadence’s combination pill, adding additional requirements on monitoring the blood pressure of study participants. The new requirements, which forced Cadence to update its label and redo the comprehension studies, delayed the company’s actual use test by at least a year, he said.
“We are really committed to seeing this all the way through,” Miller told POLITICO.
Advocates are also promoting an OTC designation for the pills without limiting their use to adults. They argue that science shows oral contraceptives are safe and effective in teens and any forays into age limits would be tantamount to politicizing the switch from OTC.
“I would be much more worried [people over 80] take something that could cause them injury compared to the under-15 crowd taking a drug that you can’t overdose on, which has no adverse events whatsoever, “Wood said.
Proponents of OTC birth control say removing barriers to oral contraceptives is not a substitute for safe abortions, but it does provide an extra tool for people to prevent unwanted pregnancies.
“Everyone should have the freedom to determine their own life path,” said Victoria Nichols, project director for the Free the Pill campaign, associated with the OTC Pill Working Group. “Both contraception and abortion are part of the full range of sexual and reproductive health care that allows us to exercise this freedom.”