“Access to over-the-counter pills is indeed a matter of justice, and now, as never before, we must do everything in our power to break down barriers to contraception, knowing that access to abortion will be much more difficult in this country , ”Said Reagan McDonald-Mosley, CEO of the nonprofit organization Power to Decide, which works to prevent unplanned pregnancies.
The prospect of having daily birth control pills anywhere people can buy drugs without a doctor’s supervision came nearly two decades after a fierce battle with the FDA over an emergency contraceptive drug known as “Plan B” available without a prescription – a political controversy. which led to the resignation of Susan Wood, director of the agency’s health department.
“Reviewers and management are under pressure from all sides, so it’s important that FDA protection is in place, maintained and strengthened because it’s imperfect,” said Wood, now a professor of health policy at George Washington University. .
Democratic lawmakers are pushing the FDA to take action soon after applications are filed. “The health and well-being of pregnant women across America is at stake,” wrote 59 members of the House of Representatives in March, led by Pro-Choice Caucus Speaker FDA Commissioner Robert Calif.
Meanwhile, some conservative lawmakers are working to restrict access to contraception, and Saint. Marsha Blackburn (R-Tenn.) Questioned the legal precedent that establishes the right to confidentiality for access to contraceptives, during a hearing on the nomination of Supreme Court Justice Ketanji Brown Jackson.
A coalition of reproductive rights groups, researchers and clinicians has been working to offer hormonal contraceptives without a prescription for nearly two decades. The Working Group on Oral Prescription Contraceptives, of which Wood is a member, began working with HRA Pharma in 2016 to conduct research to help support the OTC designation application.
The American College of Obstetricians and Gynecologists and the American Academy of Family Physicians have supported over-the-counter contraceptive pill options that OTC proponents say suggest the FDA can and should approve the transition.
“I don’t think we would have started this if it hadn’t, and that should affect FDA support,” he said. Samantha Miller, CEO of Cadence Health.
Birth control pills, although absolutely safe, can complicate some basic health conditions and always require medical supervision.
Some proponents say it will probably be easier to do HRA without a prescription because it poses less risk to different groups of people. Hanna is a pill that contains only progestin, which means less likely to have side effects. Cadence makes combination pills that contain a mixture of estrogen and progestin. People over the age of 35, smokers or those with poor blood pressure control or blood clotting disorders may be advised to avoid combination pills.
Both companies should also make sure that consumers understand the label and follow the instructions that accompany the medication.
A HRA Pharma spokesman declined to comment. But Miller said the FDA has delayed clinical trials of Cadence combination pills, adding additional requirements to control participants’ blood pressure. New requirements, which have forced Cadence to update its label and repeat research understanding, have postponed testing the company’s actual use for at least a year, she said.
“We are really trying to bring this to an end,” Miller told POLITICO.
Proponents are also promoting the labeling of over-the-counter pills without restricting their use by adults. They argue that science shows that oral contraceptives are safe and effective for teens, and any raid on age restrictions will equate to the politicization of OTC switching.
“I would worry a lot more [people over 80] taking something that could hurt them than a crowd under 15 taking an overdose drug that has no side effects, ”Wood said.
Proponents of OTC contraception say removing barriers to oral contraceptives is not a substitute for safe abortion, but provides another tool for people to prevent unwanted pregnancies.
“Everyone should have the freedom to determine their own way of life,” said Victoria Nichols, director of the Free the Pill project, which is part of the OTC Working Group on Tablets. “Both contraception and abortion are part of the full range of sexual and reproductive health care that allows us to enjoy this freedom.”