FOR IMMEDIATE RELEASE
July 13, 2023
Contact: Colleen McCabe (colleen@caminopr.com or 917-410-7240)

Monumental breakthrough: FDA approves first birth control pill for over-the-counter status

Second OTC birth control pill, used by over 90% of pill users, nearing final research stages

WASHINGTON — In a landmark advancement for reproductive health and equity, today the Food and Drug Administration announced approval for over-the-counter status for the progestin-only oral contraceptive, Opill. The decision — which follows the unanimous (17-0) recommendation from the FDA expert advisory committee — marks the first daily contraceptive pill available without the medically unnecessary barrier of a prescription.

The nonprofit, Contraceptive Access Initiative (CAI), which advocates for expanded access to contraceptives, praised the ruling.

“More people will now have convenient access to one of the most reliable and popular forms of contraception without having to wait weeks or months for a medical appointment,” said Dr. Raegan McDonald-Mosley, CEO of Power to Decide, chief medical advisor for CAI and a practicing OB-GYN. “This major breakthrough is especially meaningful for those facing the most barriers, including people living in contraceptive deserts.”

Affordability for all is crucial for reducing unintended pregnancy and supporting people’s personal decision making about their reproductive health. President Biden’s recent executive order, which directs the agencies to make over-the-counter contraception affordable, including coverage by insurance plans, is a huge step forward toward ensuring access for all.

CAI Co-founder, Dana Singiser, urged the FDA to move in a timely manner on the review and approval process for Zena.

“Approving the progestin-only pill for over-the-counter sales is a huge step forward for widespread access to high quality contraception,” said CAI co-founder Dana Singiser. “Ensuring affordability for the pill OTC is also critical to eliminating barriers — and is the aim of President Biden’s executive order to expand and protect access to contraception.”

The FDA is working with Cadence OTC on an over-the-counter application for the most commonly taken type of daily oral contraceptive — a combined estrogen-and-progestin pill. It is expected that the company will begin final testing next year.

CAI is working on a 4-step action plan to ensure widespread availability of the birth control pill.

1. Increase awareness of and support approval of the progestin-only pill (Opill) for over-the-counter status

2. Increase awareness of and support approval of l the combined hormonal contraception – (Zena) for over-the-counter status 

3. Clarify that over-the-counter contraceptives must be covered by insurance in the same way that prescription contraceptives are covered

4. Ensure that people without insurance have access through various avenues

Resources

Visit the Contraceptive Access Initiative website to learn more about:

• FDA approval process for over-the-counter access to birth control

• The two birth control pills that have been under FDA review

• The White Paper on insurance coverage for over-the-counter contraception

• Supporters of the pill over-the-counter, including medical groups, medical experts, and voters

• Opponents of the pill over-the-counter

Please contact Colleen McCabe (colleen@caminopr.com) to request interviews with experts or personal storytellers.

Polling shows widespread support for the pill OTC

Multiple polls show a public mandate among voters and the public for access to the birth control pill without the medically unnecessary barrier of a prescription.

• An April 2023 national poll found a huge majority of likely voters – 78% – think it is important for “the U.S. make access to the pill and other contraceptives more easily available.” In addition:

• Majorities across all demographics — party, ideological spectrum, race, gender, age, parental status — support OTC birth control.

• Hispanic women are especially supportive of birth control (83%), making contraceptives more easily available (93%) and OTC access (81%).

• Age restrictions are not a decisive factor in support for oral contraceptive over-the-counter status. Only 7% of all voters oppose making the pill available OTC, but would support it if there were age restrictions.

• Among the 23% of voters who oppose allowing the pill to be sold over the counter, over half (56%) are opposed to oral contraception use in any circumstance.

• A November 2022 KFF poll found that more than three-quarters (77%) of reproductive age females favor making birth control pills available over the counter without a prescription if research showed they are safe and effective.

Opponents

The Catholic Church and some anti-abortion leaders have been campaigning against contraception, including over-the-counter status for the pill.

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The nonprofit Contraceptive Access Initiative (CAI) advocates for increasing access to hormonal contraception over the counter, free from stigma, bias and coercion. Follow CAI on Twitter @ThePillOTC and on LinkedIn.