The Food and Drug Administration will consider an application for the first birth control pill to be sold without a prescription.
The application from HRA Pharma would seek to make Opill – an every day, prescription-only hormonal contraception first approved in 1973 – available over-the-counter. Such an approval from the FDA would allow people to purchase “the pill” without a prescription for the first time since oral contraceptives became widely available in the 1960s.
The application will also cast oral contraceptives into a fraught political moment in the US. The US supreme court ended federal protection for abortion rights late last month, throwing into question the future of birth control.
The drugmaker said the timing is unrelated. A decision on the application could come as soon as 2023.
“This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the US,” said HRA Pharma’s chief strategic operations and innovation officer, Frédérique Welgryn. “More than 60 years ago, prescription birth control pills in the US empowered women to plan if and when they want to get pregnant.”
Making birth control available without a prescription will “help even more women and people access contraception without facing unnecessary barriers”, said Welgryn, whose company has already submitted the application.
Most oral contraceptives are exceedingly safe, using a combination of estrogen and progestin to prevent pregnancy. Opill uses only progestin, which may make it a better candidate for over-the-counter marketing, since it can be used even by people with a history of blood clotting or uncontrolled high blood pressure, according to the American College of Obstetricians and Gynecologists (ACOG).
However, the “mini-pill,” as some progestin-only contraceptives are called, also has side effects. The most common is breakthrough bleeding between periods, which can be unpredictable, according to ACOG.
Presently, all hormonal daily birth control pills require a prescription in the US, and many are covered by health insurance. However, obtaining such a prescription has been difficult for many US women. Roughly one-in-four women who had ever attempted to get a hormonal birth control prescription reported difficulty doing so, often because of language barriers, lack of insurance or cost, according to a 2015 study.
If approved, over-the-counter birth control would be a victory years in the making. The Free the Pill Coalition has worked to make birth control available without a prescription for nearly two decades in the US, saying it is now available without a prescription in more than 100 countries. The American Medical Association, which is the nation’s largest professional association of doctors, said in June it supports over-the-counter birth control.
Over-the-counter birth control would also provide an alternative form of family planning in the chaotic aftermath of the supreme court’s decision to overturn its landmark 1973 ruling in Roe v Wade, which granted federal abortion protections.
Several states have already begun to enforce near-total abortion bans, and that number is expected to grow to at least 26 in the coming weeks.
The debate about abortion rights could spill over into the FDA’s work on contraception. Already, contraception is among the most politicized aspects of the agency’s work. Emergency contraception, sold under the brand name “Plan B” in the US, is already available over-the-counter. The FDA recently said medication to terminate a pregnancy, often called the “abortion pill” or “medication abortion,” can be prescribed via telemedicine.
However, states hostile to abortion and anti-abortion groups have already signaled that medication abortion is the next battleground for clamping down on abortion rights. That could put the FDA and states into direct conflict as states seek to regulate a medication that was federally approved.
That conflict is likely to be sorted out in court. Should it reach the supreme court, the battle between the FDA and states could come before a conservative supermajority, some members of which have already expressed a willingness to overturn federal rights to contraceptives and to re-evaluate the power of federal agencies to regulate states.