Federal agencies will meet this spring to decide whether to make an over-the-counter birth control pill available to women.
Opill, made by French drugmaker HRA Pharma, could become the first over-the-counter anti-progestin pill ever approved in the US.
The Food and Drug Administration will meet in May to discuss the company’s application to manufacture Opill, a daily birth control pill that can cost up to $50 a pack without insurance, as an over-the-counter drug.
The company filed the application only last summer, in the weeks following the Supreme Court’s decision to overturn the federal guarantee of legal and safe abortion. The FDA review process can take about a year.
The agency’s decision to issue advice on OTC birth control comes about nine months after Justice Clarence Thomas, who he said supported the Supreme Court’s decision to overturn the federal guarantee on abortions, indicated that legal access to birth control would be restored become
Opill and other oral contraceptives like it have been used safely by millions of women for about 60 years, but the US is an outlier when it comes to making the pills available without a prescription
About three dozen health professional organizations, including the American Medical Association, the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Family Physicians, have advocated over-the-counter birth control pills for years.
Opill and other oral contraceptives like it have been used safely by millions of women for more than 60 years, but the US is an outlier when it comes to making the pills available without a doctor’s prescription.
With the recent upheaval in the US legal system regarding abortion procedures and pills in the US, there is increasing pressure on health officials to ensure the already poor access to contraception for many women.
Two FDA advisory committees — the OTC Advisory Committee and the Reproductive and Urology Advisory Committee — will meet on May 9 and 10 to review HRA Pharma’s Rx-to-OTC switch application for Opill.
Sometimes referred to as the ‘mini-pill’, Opill contains only progestin, unlike many oral contraceptives, which contain both progestin and estrogen.
That’s the appeal of the mini pill. Since they do not contain estrogen, which increases the risk of blood clotting many times over, the progestogen-only pills are considered less risky.
The modus operandi consists of thickening the mucus in the cervix, which makes it difficult for sperm to enter the uterus and fertilize an egg.
Progestogen-only pills do not prevent ovulation as well as combined birth control pills. Therefore, the efficiency is slightly lower.
DR Daniel Grossman, director of the Advancing New Standards in Reproductive Health (ANSIRH) program at the University of California, San Francisco, said: “Oral contraceptives are some of the safest medications I can prescribe for my patients and the science knows that they are safe and effective for over-the-counter use. Prescription requirements create a medically unnecessary barrier that continues to make health care unattainable.’
Many other countries in Latin America and Europe offer access to contraceptives without a prescription, but the US is lagging behind.
In 2021, the UK approved its first ever OTC option, also manufactured by HRA Pharma.
When it comes to abortion rights and access to reproductive health care, the American political landscape is fragmented and vicious.
Right now, right-wing doctors and political activist groups are fighting in court to strip FDA approval of mifepristone, an ingredient in a two-drug cocktail that safely and effectively ends a pregnancy without surgery.
Advocates of over-the-counter birth control have made their case for years, pointing to stark racial and wealth disparities that make access to birth control difficult for minority communities, the young and the poor.
Prescription requirements create barriers for young people and the poorest who do not have health insurance or do not have the financial means to pay for a doctor and make arrangements around that appointment, such as e.g. B. the organization of childcare and transport.
Over-the-counter birth control available at regular pharmacies would also be a boon to the millions of American women who live in what are known as birth control deserts — geographic areas that lack funding from federal and state programs like Title X and Medicaid not, which changes the number of low-cost family planning clinics needed to serve a particular population.
Most Americans fear that SCOTUS will restrict birth control after Roe is overturned
After the Supreme Court overturned the federal abortion guarantee last summer, 55 percent of respondents feared that access to birth control could be next.
Victoria Nichols, project leader at Free the Pill Advocacy Group, said: “It’s time to get the pill to market and ensure that those who have long faced the greatest barriers to care, due to systemic inequalities, have access to a over-the-counter birth control pill that is affordable and covered by insurance.
“The days of current prescription – a barrier that black, Native American, Latina/X, Asian American, Native Hawaiian and Pacific Islander, LGBTQ+ people, youth, those with disabilities and those who work to make their lives, separated, out of proportion – is numbered.’
Access to effective contraception is critical to public health, as approximately half of all pregnancies are unintended.
The annulment of the Roe v. Wade’s 1973, which established the federal guarantee for abortion, in SCOTUS last year was not entirely unexpected by pro- and anti-abortion advocates, as a draft advisory opinion was leaked about a month earlier.
But something about Justice Clarence Thomas’s approval made abortion rights advocacy groups shudder.
Justice Thomas wrote that the suppression of Roe v. Wade should also open the Supreme Court to review other precedents that could be considered “proven wrong,” including the right for married couples to buy and use birth control without government restrictions, stemming from the landmark 1965 ruling in the case Griswold vs. . Connecticut.
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Crystal Leahy is an author and health journalist who writes for The Fashion Vibes. With a background in health and wellness, Crystal has a passion for helping people live their best lives through healthy habits and lifestyles.
