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For First Time Ever, FDA Approves Over-the-Counter Birth Control Pill

The pill’s readiness and pricing will be determined by its manufacturer, the FDA said in a statement.

The U.S. Food and Drug Administration (FDA) announced on Thursday morning that it has approved for use a birth control pill that can be sold over the counter, without the need for a prescription from a physician.

It’s unclear when the medication, Opill (norgestrel), a progestin-only oral contraceptive, will be available, as the FDA has said that its readiness and eventual pricing will be “determined by the manufacturer.” Reproductive rights activists have expressed concern that the cost of the pill may be prohibitive, making it difficult for some people to access, although the company that manufactures the pill, Perrigo Company, has vowed to make it “accessible and affordable to women and people of all ages.”

The decision by the federal agency — the first time a birth control pill has been approved for over-the-counter use in the U.S. — is being lauded as a huge step forward for accessibility to such medication.

“Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online,” the FDA said in an online press release.

Like many birth control pills, Opill has to be taken at the same time every day in order to be effective. Users of the pill must also be mindful of other medications they’re taking that could interfere with the pill’s efficacy. If taken consistently and without deviation from the directions for its use, the pill has a 98 percent efficacy rate.

Health professionals and reproductive rights activists are praising the FDA’s recent action while noting that additional steps are necessary to ensure that more people have access to birth control in the near future.

“OTC birth control is available in over 100 countries, so we’ve been behind in availing safe, effective methods such as this oral contraceptive pill to individuals who are trying to avoid pregnancy,” Dr. Melissa Simon, a professor of clinical gynecology at Northwestern University, told NBC News about the FDA’s announcement.

“Over the counter birth control pills will help bridge gaps in access and give people greater control over their reproductive health and lives. … FDA approval is an important step forward, but we must ensure that OTC birth control pills are equitably accessible to all,” said Victoria Nichols, project director of Free the Pill. “To ensure equitable access we must continue to advocate for OTC birth control pills to be affordably priced and fully covered by insurance.”

Jen Miller, communications Manager of URGE, a national youth-led reproductive rights and justice organization, praised the work of those who fought for years for the FDA’s decision to become reality.

“This major win would not have been possible without decades of tireless activism by young people raising their voices and working to increase access to contraceptives for all,” Miller said in an email to Truthout. “We stand alongside all young people who continue to push for progress.”

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