FDA to vote on whether to make birth control pills available over the counter in May

Federal regulators will convene this spring to decide whether to make a birth control pill available to women without a prescription.

Opill, manufactured by French drugmaker HRA Pharma, could become the first progestin-only over-the-counter birth control pill ever approved in the US.

The Food and Drug Administration will meet in May to discuss the company’s application to make Opill, a daily birth control pill that can cost up to $50 per pack without insurance, an over-the-counter medication available without a prescription. 

The firm initially submitted the request last summer in the weeks following the Supreme Court’s decision to revoke the federal guarantee to legal and safe abortion. The FDA review process can take about a year. 

The agency’s move to deliberate on OTC birth control comes about nine months after Justice Clarence Thomas, in his opinion supporting the Supreme Court’s decision to nix the federal guarantee to abortion, hinted that legal access to contraception should be reexamined. 

Roughly three dozen organizations of health experts such as the American Medical Association, the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Family Physicians have been calling for a non-prescription birth control pill option for years.

Opill and other oral contraceptives like it have been used safely by millions of women for over 60 years, but the US is an outlier when it comes to making the pills available without a doctor’s order. 

With recent upheavals in the US legal system over abortion procedures and pills in the US, pressure is mounting on health officials to safeguard the already tenuous access many women have to contraception.

Two FDA advisory committees — the Nonprescription Drugs Advisory Committee and the Reproductive and Urologic Drugs Advisory Committee — will come together on May 9 and 10 to consider HRA Pharma’s Rx-to-OTC switch application for Opill.

Sometimes referred to as the ‘mini pill,’ Opill contains progestin only, unlike many oral contraceptives that contain both progestin and estrogen. 

This is the appeal of the mini-pill. Because it does not contain estrogen, which increases the risk of blood clotting by several-fold, the progestin-only pills is seen as lower-risk.

Its modus operandi is to thicken mucus in the cervix, making it difficult for sperm to enter the uterus and fertilize an egg. 

Progestin-only pills do not prevent ovulation as well as combination birth control pills. Therefore, its effectiveness 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 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. The prescription requirement serves as a medically unnecessary barrier that continues to keep care out of reach.’

Many other countries in Latin America and Europe provide access to birth control without a prescription, but the US has lagged behind. 

In 2021, the UK approved its first-ever over-the-counter option also made by HRA Pharma.

When it comes to abortion rights and access to reproductive healthcare, the US political landscape is fractured and vitriolic. 

Currently, right-leaning doctors and political action groups are fighting in court to revoke FDA approval of mifepristone, one in a two-drug cocktail that safely and effectively terminates a pregnancy without the need for surgical intervention.

Advocates for over-the-counter birth control have been making their case for years, pointing to the stark racial and wealth inequities that make accessing contraception harder for minority communities, young people, and the poor.

Prescription requirements create barriers for young people and the very poor who either do not have health insurance or do not have the financial resources to pay to see a doctor and make arrangements around that appointment, such as organizing childcare and transportation.

Over-the-counter birth control available at common pharmacies would also be a boon for the millions of American women who live in so-called contraceptive deserts – geographical areas that lack funding from federal and state programs, like Title X and Medicaid, to run the number of low-cost family planning clinics needed to serve a given population.

Victoria Nichols, project director of the advocacy group Free the Pill said: ‘It’s time to free the pill and ensure that those who have long faced the most barriers to care due to systemic inequities have access to an over-the-counter birth control pill that is priced affordably and covered by insurance.

‘The days of the current prescription requirement – a barrier that disproportionately impacts Black, Indigenous, Latina/x, Asian Americans, Native Hawaiian and Pacific Islander communities, LGBTQ+ folks, young people, people with disabilities, and those working to make ends meet – are numbered.’

Access to effective birth control is crucial to public health, as roughly half of all pregnancies are unintended.

Last year’s overturning in SCOTUS of the 1973 decision Roe v. Wade, which established the federal guarantee to abortion, was not entirely unexpected by abortion advocates and opponents, as a draft opinion had leaked about a month prior.

But something in Justice Clarence Thomas’ concurring opinion sent a ripple of chills across abortion-rights advocacy organizations. 

Justice Thomas wrote that striking down Roe v. Wade should also open up the high court to review other precedents that may be deemed ‘demonstrably erroneous,’ including the right for married couples to buy and use contraception without government restriction stemming from the landmark 1965 ruling in Griswold v. Connecticut.