By Matthew Perrone | The Associated Press
The United States officials have granted approval for the first over-the-counter birth control pill, allowing American women and girls to purchase contraceptive medication from the same aisle as aspirin and eyedrops. This move marks a significant milestone in women’s reproductive healthcare access.
The Food and Drug Administration (FDA) announced on Thursday that it has cleared Perrigo’s Opill, a once-a-day hormone-based pill, to be sold without a prescription. This makes it the first contraceptive medication to be relocated from behind the pharmacy counter. The pill will be available for shipping in early next year, and there will be no age restrictions on sales.
Birth control pills have been the most commonly used form of contraception in the U.S. since the 1960s. However, until now, they all required a prescription.
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Various medical societies and women’s health groups have been advocating for broader access to birth control, highlighting the fact that approximately 45% of the 6 million pregnancies in the U.S. every year are unintended. Young women, women of color, and those with low incomes often face significant obstacles in obtaining prescriptions and picking up their medication.
These obstacles can include financial constraints, difficulty taking time off from work, and challenges finding suitable childcare options.
Kelly Blanchard, the president of Ibis Reproductive Health, a non-profit organization that has supported the approval, states, “This marks a transformative step towards improving access to contraceptive care. Hopefully, this will help individuals overcome the existing barriers.”
Perrigo, an Ireland-based company, has not announced the price of the over-the-counter pill. Generally, over-the-counter medicines are less expensive than prescription medications, but they are typically not covered by insurance.
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Requiring insurance companies to cover over-the-counter birth control would necessitate a regulatory change by the federal government. Various women’s advocates are urging the Biden administration to implement such changes.
In recent decades, many common medications, including those for pain, heartburn, and allergies, have transitioned to non-prescription status. Birth control pills are already available without a prescription across large parts of South America, Asia, and Africa.
Perrigo submitted several years of research to the FDA to demonstrate that women can comprehend and follow the instructions for using the pill. Despite some concerns raised by FDA scientists regarding the company’s results, including whether women with certain underlying medical conditions would understand that they should not take the drug, Opill received FDA approval.
It is important to note that the FDA’s decision only applies to Opill, which belongs to an older class of contraceptives known as minipills. These pills contain a single synthetic hormone and generally have fewer side effects compared to the more popular combination hormone pills.
Women’s health advocates are hopeful that this decision will pave the way for additional over-the-counter birth control options and, potentially, for over-the-counter abortion pills as well.
However, it is crucial to clarify that the FDA’s decision is unrelated to the ongoing court battles surrounding the abortion pill mifepristone. Perrigo’s FDA application and the studies it submitted began years before the Supreme Court’s reversal of Roe v. Wade, which has significantly impacted abortion access across the country.
With some states restricting women’s reproductive rights, the FDA has faced pressure from Democratic politicians, health advocates, and medical professionals to facilitate access to birth control. The American Medical Association and the leading professional society for obstetricians and gynecologists have supported Opill’s application for over-the-counter status.
An external panel of FDA advisors unanimously voted in favor of the switch during a hearing in May, where numerous public speakers advocated for Opill’s approval.
Dyvia Huitron was among those who presented during the hearing. She explained how, even after being sexually active for more than three years, she has been unable to obtain prescription birth control. The 19-year-old University of Alabama student shared that she is uncomfortable getting a prescription because the school’s health system discloses medical exams and medications to parents.
Huitron stated in a recent interview, “My parents did not let me go on the pill. There was just a lot of cultural stigma around being sexually active before marriage.”
While she utilizes other forms of contraception, Huitron expresses, “I would have much preferred to have birth control and use these additional methods to ensure that I was being as safe as possible.”
Huitron spoke on behalf of Advocates for Youth, one of the many organizations that have advocated for improved accessibility of prescription contraceptives. These groups have supported some of the studies submitted for Opill and encouraged HRA Pharma (later acquired by Perrigo) to file its application with the FDA.
Advocates were particularly interested in Opill due to its lower safety concerns. The pill was initially approved in the U.S. five decades ago, but it has not been marketed here since 2005.
Blanchard, from Ibis Reproductive Health, emphasizes, “This pill has been around for a long time, and we have ample data supporting its safety and efficacy for over-the-counter use.”
Newer birth control pills typically combine two hormones, estrogen and progestin, which can help regulate periods and reduce their intensity. However, their use comes with a higher risk of blood clots and is not recommended for women at risk of heart problems, such as smokers over the age of 35.
Opill contains only progestin, which works by preventing sperm from reaching the cervix and causing pregnancy. It must be taken at approximately the same time every day to maximize its effectiveness.
In its internal review published in May, the FDA acknowledged that some women in Perrigo’s study had difficulty understanding the drug’s label information. The instructions specifically warn that women with a history of breast cancer should not take the pill due to the potential for tumor growth. Additionally, women with abnormal vaginal bleeding are advised to consult a doctor since it could indicate an underlying medical issue.
Common side effects of the pill, as stated by the FDA, include bleeding, headaches, dizziness, nausea, and cramps. The label also cautions that certain medications, such as those for seizures, HIV, and hypertension, can interfere with Opill’s effectiveness.
Perrigo’s executives have announced plans to spend the remainder of the year manufacturing the pill and its packaging, aiming for availability in stores at the beginning of next year.
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