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

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

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

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

The firm initially filed the petition last summer in the weeks after the Supreme Court’s decision to revoke the federal guarantee of safe, legal abortion. The FDA review process can take about a year.

The agency’s move to deliberate on over-the-counter birth control comes about nine months after Justice Clarence Thomas, in his opinion upholding the Supreme Court’s decision to strike down the federal guarantee for abortion, suggested that legal access to contraception should be reexamined.

About three dozen health expert organizations like the American Medical Association, the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Family Physicians have been calling for an 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 US is an outlier when it comes to the availability of pills without a prescription.

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

Two FDA advisory committees, the Non-Prescription Drugs Advisory Committee and the Urological and Reproductive Drugs Advisory Committee, will meet on May 9 and 10 to consider HRA Pharma’s request to switch Opill from Rx to OTC.

Sometimes referred to as a “mini-pill”, Opill contains only progestin, unlike many oral contraceptives that contain both progestin and estrogen.

This is the appeal of the mini-pill. Because they do not contain estrogen, which increases the risk of blood clotting several times, progestin-only pills are considered lower risk.

Its modus operandi is to thicken the 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 for my patients, and science is clear that they are safe and effective for use without a prescription. 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 contraception without a prescription, but the United States has lagged behind.

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

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

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

Advocates of over-the-counter birth control have been making their case for years, pointing to the stark racial and wealth inequities that make contraceptive access difficult for minority communities, the young, and the poor.

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

Over-the-counter birth control available at regular pharmacies would also be a boon to the millions of American women who live in the so-called contraceptive deserts: geographic areas that are underfunded by federal and state programs, such as Title X and Medicaid, to work. the number of low-cost family planning clinics needed to serve a given population.

Victoria Nichols, project manager at advocacy group Free the Pill, said: “It is time to unleash the pill and ensure that those who have long faced the most barriers to receiving care due to systemic inequalities have access to a over-the-counter birth control pill. which is affordable and covered by insurance.

‘The days of the current prescription requirement, a barrier that disproportionately affects Black, Indigenous, Latino/x, Asian American, Native Hawaiian and Pacific Islander communities, LGBTQ+ people, youth, people with disabilities and those working to reach at the end of the month. they are numbered.

Access to effective birth control is crucial for public health, since approximately half of all pregnancies are unintended.

Last year’s reversal in SCOTUS of the 1973 Roe v. Wade, who established the federal guarantee for abortion, was not entirely unexpected by abortion advocates and opponents, as a draft opinion had leaked about a month earlier.

But something in the concurring opinion of Justice Clarence Thomas sent a ripple of chills through abortion rights organizations.

Justice Thomas wrote that quashing Roe v. Wade should also allow the high court to review other precedents that may be considered “patently erroneous,” including the right of married couples to purchase and use contraceptives without government restrictions stemming from the landmark 1965 ruling in Griswold v. Connecticut.