Federal regulators will meet this spring to decide whether the pill should be made available to women without a prescription.
Opill, made by French drugmaker HRA Pharma, could become the first over-the-counter progestin-only birth control pill approved in the United States.
The Food and Drug Administration will meet in May to discuss the company’s request to make Opill, a daily pill that can cost up to $50 per pack without insurance, an over-the-counter drug available without a prescription.
The company initially filed the application last summer in the weeks after the Supreme Court’s decision to strike down the federal guarantee of legal and safe abortion. The FDA review process can take about a year.
The agency’s move to deliberate on over-the-counter contraceptives comes nearly nine months after Justice Clarence Thomas, in his opinion supporting the Supreme Court’s decision to overturn the federal guarantee of abortion, hinted that legal access to contraceptives should be reconsidered.
Opill and other oral contraceptives have been used safely by millions of women for nearly 60 years, but the United States is an anomaly when it comes to making birth control pills available without a prescription.
Nearly thirty health expert organizations such as the American Medical Association, the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Family Physicians have been touting the over-the-counter birth control pill option for years.
Opill and other oral contraceptives have been used safely by millions of women for more than 60 years, but the United States is an anomaly when it comes to making birth control pills available without a doctor’s request.
With recent upheavals in the American legal system over US abortion procedures and pills, pressure is mounting on health officials to protect many women’s already poor access to contraceptives.
Two FDA advisory committees — the Non-Prescription Drugs Advisory Committee and the Reproductive and Urological Drugs Advisory Committee — will meet May 9 and 10 to consider HRA Pharma’s Rx-to-OTC switch application for Opill.
Sometimes referred to as the “mini-pill,” Opal contains only a progestin, unlike many oral contraceptives that contain both a progestin and an estrogen.
This is the allure of the little bean. Since it does not contain estrogen, which increases the risk of blood clots many times over, progestin-only pills are seen as less risky.
The way it works is to thicken the mucus in the cervix, making it more difficult for sperm to enter the uterus and fertilize an egg.
The progestin-only pill does not prevent ovulation as well as the combined pill. Therefore, its effectiveness is slightly lower.
“Oral contraceptives are one of the safest medications I can prescribe to my patients, and the science is clear that they are safe and effective for over-the-counter use,” said Dr. Daniel Grossman, director of the Development of New Standards in Reproductive Health (ANSIRH) Program at the University of California, San Francisco. The prescription requirement is a medically unnecessary barrier that continues to keep care out of reach.
Many other countries in Latin America and Europe provide access to over-the-counter contraceptives, but the United States has lagged behind.
In 2021, the UK approved the first over-the-counter option, also introduced by HRA Pharma.
When it comes to abortion rights and access to reproductive health care, the political landscape in the United States is fractured and acrimonious.
Currently, doctors and political action groups are fighting in court to overturn the FDA’s approval of mifepristone, the one in a two-drug cocktail that safely and effectively ends a pregnancy without the need for surgery.
Over-the-counter contraceptive advocates have been making their case for years, pointing to the violent disparities and wealth that make access to contraceptives more difficult for minorities, the young, and the poor.
Prescription requirements create barriers for young people and the very poor who either don’t have health insurance or don’t have the financial resources to pay to see a doctor and make arrangements around that appointment, such as organizing child care and transportation.
Over-the-counter contraceptives available at public pharmacies will also be a boon for the millions of American women who live in so-called contraceptive deserts — geographic areas that lack funding from federal and state programs, such as Title X and Medicaid, to power them. The number of low-cost family planning clinics needed to serve a given population.
Victoria Nicholls, project director of the advocacy group Free the Pill, said: ‘It’s time to free up the pill and make sure those who have long faced the most significant barriers to accessing care because of systemic inequalities have access to the over-the-counter pill. medical. Reasonably priced and covered by insurance.
The days of current prescription requirements—a barrier that disproportionately affects Blacks, Indigenous people, Latino/Q, Asian Americans, Native Hawaiian and Pacific Islander communities, LGBTQ+ people, youth, people with disabilities, and those who work to make ends meet—are numbered.
Access to effective contraception is critical to overall health, as nearly half of all pregnancies are unintended.
Last year, the overturning of the 1973 Roe v. Wade decision in the SCOTOS court, which created the federal guarantee for abortion, wasn’t entirely unexpected by abortion advocates and opponents of abortion, as a draft opinion leaked about a month earlier.
But something in Justice Clarence Thomas’ favorable opinion sent chills through abortion rights organizations.
Dropping Roe v. Wade, Justice Thomas wrote, should also open the Supreme Court up for review of other precedents that could be deemed ‘patently wrong’, including the right for couples to buy and use contraceptives without government restrictions arising from the landmark 1965 ruling in Griswold v. Connecticut.
