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FDA Approves First over-the-Counter Birth Control Pill in U.S.



FDA Approves First over-the-Counter Birth Control Pill in U.S.

(CTN News) – The recent approval of the Birth Control Pill, an oral contraceptive, for over-the-counter sale in the United States by the Food and Drug Administration (FDA) marks a significant milestone in improving access to birth control.

However, despite this development, some women and girls may still encounter obstacles in obtaining the pill due to potential insurance coverage gaps.

While Opill’s manufacturer, Perrigo, aims to ensure affordability through a patient assistance program, the lack of mandatory insurance coverage for non-prescription birth control pills could hinder access for certain individuals.

Insurance Coverage Challenges:

Under the Affordable Care Act (ACA), private health insurance plans are not obliged to cover the cost of over-the-counter medications, including Opill, when used without a prescription.

Most health insurers are required to offer prescription birth control for free. Moreover, state Medicaid programs are generally not mandated to cover non-prescription drugs. These factors create potential barriers for women and girls seeking access to Opill through their insurance coverage.

Perrigo’s Efforts and Challenges:

Perrigo, the manufacturer of Opill, acknowledges the importance of affordability and is committed to making the pill accessible.

The company plans to establish a patient assistance program to address financial barriers faced by women with limited resources. Additionally, Perrigo is actively working to engage private insurance and state Medicaid programs to provide free access to over-the-counter Opill.

However, implementing comprehensive insurance coverage for non-prescription birth control pills will require legislative adjustments to the ACA, posing a time-consuming challenge.

Government Initiatives and Advocacy:

Recognizing the need to expand access to contraception, President Joe Biden and congressional Democrats are taking steps to address the issue.

Senator Patty Murray reintroduced the Affordability is Access legislation, which advocates for health insurers to offer oral contraceptives without a prescription at no cost.

In June, President Biden ordered the U.S. Department of Health and Human Services to ensure that all FDA-approved contraceptives are available without out-of-pocket expenses.

The Centers for Medicare & Medicaid Services (CMS) actively encourages insurance coverage of over-the-counter contraceptive products without cost sharing.

Importance of Opill and Unintended Pregnancies:

Opill, with its 93% effectiveness in preventing pregnancy, represents the most potent over-the-counter contraception option in the U.S. Currently, an estimated 15 million sexually active women rely on less effective forms of contraception or no contraception at all.

Nearly half of the six million pregnancies each year in the U.S. are unintended, leading to potential negative health outcomes for newborns, such as preterm delivery.


While the FDA’s approval of over-the-counter access to Opill is a significant advancement for women’s reproductive health, challenges regarding insurance coverage remain.

Perrigo is working to establish comprehensive coverage, but legislative amendments are necessary to ensure that private health insurance and state Medicaid programs cover non-prescription birth control.

The efforts of President Biden and congressional Democrats reflect a commitment to expanding access to contraception and reducing unintended pregnancies. By addressing insurance coverage gaps, society can enhance reproductive healthcare and empower women and girls to make informed choices about their reproductive well-being.

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