Posted on Jul 14, 2022
Over-the-counter birth control pills are available worldwide. The U.S. may be next
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https://www.npr.org/sections/health-shots/2022/07/14/ [login to see] /over-the-counter-birth-control-pills
A pharmaceutical company based in Paris, HRA Pharma, is seeking approval from the U.S. Food and Drug Administration for an over-the-counter birth control pill. The pill includes progestin only, not estrogen, and is known as a mini pill. If approved, it would be the first oral contraceptive available in the U.S. without a prescription.
"This could be a really groundbreaking change in access," says Victoria Nichols of Free the Pill, a coalition of advocates, researchers and health care providers that has helped lay the groundwork and build support for regulatory approval of over-the-counter pill options in the United States.
The coalition's work began more than a decade ago, but the application for approval — submitted in the wake of the overturning of Roe v. Wade — comes at a time of renewed attention to the importance of contraception access. "I think there's absolutely greater urgency today to have better contraceptive access across the United States," says Cynthia Harper, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco.
A pharmaceutical company based in Paris, HRA Pharma, is seeking approval from the U.S. Food and Drug Administration for an over-the-counter birth control pill. The pill includes progestin only, not estrogen, and is known as a mini pill. If approved, it would be the first oral contraceptive available in the U.S. without a prescription.
"This could be a really groundbreaking change in access," says Victoria Nichols of Free the Pill, a coalition of advocates, researchers and health care providers that has helped lay the groundwork and build support for regulatory approval of over-the-counter pill options in the United States.
The coalition's work began more than a decade ago, but the application for approval — submitted in the wake of the overturning of Roe v. Wade — comes at a time of renewed attention to the importance of contraception access. "I think there's absolutely greater urgency today to have better contraceptive access across the United States," says Cynthia Harper, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco.
Over-the-counter birth control pills are available worldwide. The U.S. may be next
Posted from npr.org
Medical
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Posted 2 y ago
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PO1 William "Chip" Nagel
..."HRA Pharma must meet a bunch of criteria to win over-the-counter approval in the United States. For instance, it must provide evidence that individuals would be able to screen themselves to determine whether the pill was right for them. The company must also show that people could take the daily contraceptive pill as intended without a doctor’s explanation. “That’s something the pharmaceutical company has to prove through their data and research,” says Free the Pill’s Nichols. She explains that the coalition has helped build evidence over the last decade, which she says is strong. “We believe that these pills are safe and effective and that people should be able to follow the simple instructions,” says Nichols.
In March, a group of lawmakers, including the co-chairs of the Pro-Choice Caucus in the House of Representatives, sent a letter to FDA Commissioner Robert Califf urging the agency to review applications for over-the-counter birth control pills without delay. The lawmakers pointed to systemic inequities in the health care system that create barriers to access. “These barriers are disproportionately borne by people of color, immigrants, LGBTQ+ people, low-income individuals, young people, and people in rural communities — individuals who have faced and continue to face the greatest inequities,” the letter stated. The lawmakers said the FDA has an important role to play in reducing barriers to help provide people greater control over their reproductive health.
The FDA review process is expected to take about 10 months, with a decision expected in 2023."
..."HRA Pharma must meet a bunch of criteria to win over-the-counter approval in the United States. For instance, it must provide evidence that individuals would be able to screen themselves to determine whether the pill was right for them. The company must also show that people could take the daily contraceptive pill as intended without a doctor’s explanation. “That’s something the pharmaceutical company has to prove through their data and research,” says Free the Pill’s Nichols. She explains that the coalition has helped build evidence over the last decade, which she says is strong. “We believe that these pills are safe and effective and that people should be able to follow the simple instructions,” says Nichols.
In March, a group of lawmakers, including the co-chairs of the Pro-Choice Caucus in the House of Representatives, sent a letter to FDA Commissioner Robert Califf urging the agency to review applications for over-the-counter birth control pills without delay. The lawmakers pointed to systemic inequities in the health care system that create barriers to access. “These barriers are disproportionately borne by people of color, immigrants, LGBTQ+ people, low-income individuals, young people, and people in rural communities — individuals who have faced and continue to face the greatest inequities,” the letter stated. The lawmakers said the FDA has an important role to play in reducing barriers to help provide people greater control over their reproductive health.
The FDA review process is expected to take about 10 months, with a decision expected in 2023."
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