FDA approves first over-the-counter birth control pill

American authorities have granted the green light to the initial non-prescription birth control pill, permitting women and young girls to purchase contraceptive medicine from the identical section as headache relief tablets and eye care drops.

The Food and Drug Administration announced on Thursday that Perrigo's Opill, a medication taken once daily, has been approved for over-the-counter sales. This makes it the inaugural drug of its kind to be made available outside the confines of the pharmacy counter. Perrigo plans to commence shipping the pill in the early months of next year, and there will be no limitations on who can purchase it based on age.

For decades, hormone-based tablets have been widely used as the prevailing method of contraception in the United States. These pills have been relied upon by countless women since the 1960s, but up until this point, obtaining them has always necessitated a doctor's prescription.

Various medical organizations and women's health associations have advocated for increased availability, highlighting the fact that approximately 45% of the 6 million yearly pregnancies in the United States occur without intention. Adolescents, young females, women belonging to diverse ethnicities, as well as individuals with limited financial resources, commonly encounter more difficulties in obtaining prescriptions and collecting their required medications.

There are several difficulties that one may face, such as covering the cost of a medical appointment, securing leave from work, and arranging for childcare.

Kelly Blanchard, the president of Ibis Reproductive Health, a non-profit organization that backed the approval, expressed enthusiasm about the significant progress made in the accessibility of contraceptive care. She expressed optimism that the newly approved measures will play a crucial role in eliminating the existing obstacles people face in this regard.

Perrigo, a company based in Ireland, refrained from disclosing the cost. Generally, over-the-counter medications are significantly more affordable compared to prescribed ones, yet they are not eligible for insurance coverage.

In the past few decades, numerous widely-used medicines have transitioned to being available without a prescription. This includes medications for various ailments such as pain, heartburn, and allergies.

Perrigo presented an extensive body of research to the FDA to demonstrate that women possess the ability to comprehend and comply with the instructions for utilizing the pill. Despite certain reservations expressed by FDA researchers about the outcomes reported by the company, such as whether women affected by specific pre-existing medical conditions would recognize the fact that they should refrain from taking the medication, Thursday marked the official approval.

The decision made by the FDA only pertains to Opill. This particular contraceptive falls under the category of older contraceptives, also known as minipills, which consist of a solitary artificial hormone. Typically, minipills have lesser side effects compared to the more widely used combination hormone pills.

However, proponents of women's health are optimistic that this ruling will set a precedent for increasing availability of birth control methods without prescription. They also aspire to see a future where the same openness applies to abortion pills.

However, it is important to note that the FDA's ruling is not connected to the ongoing legal disputes surrounding the use of mifepristone, a medication for abortion. The research included in Perrigo's submission to the FDA was initiated prior to the Supreme Court's decision to overturn Roe v. Wade, resulting in significant changes to abortion availability throughout the United States.

As certain states limit the rights of women to make decisions about their reproductive health, the FDA has been urged by politicians from the Democratic party, health champions, and healthcare experts to make birth control more accessible. The American Medical Association and the primary organization for obstetricians and gynecologists have supported Opill's request to become available without a prescription.

A group of FDA evaluators from external sources openly and completely supported the change during a meeting in May, in which many members of the public advocated for the approval of Opill.

Dyvia Huitron was one of the individuals who spoke, detailing her struggles in obtaining prescribed contraceptive methods after being sexually active for over three years. The 19-year-old student at the University of Alabama expressed her reluctance in seeking a prescription due to the school's healthcare system's practice of informing parents about medical check-ups and medications.

"In a recent interview, Huitron stated that her parents prohibited her from using contraceptive pills. They expressed concern about the societal shame associated with engaging in sexual activities prior to getting married."

Although she utilizes different methods of contraception, "I would have greatly preferred having access to birth control and employing these supplementary approaches to maximize my safety."

Huitron represented Advocates for Youth, an organization among many others that have advocated for greater accessibility to prescription contraceptives.

The organizations provided financial support for several research projects included in Opill and they urged HRA Pharma, which was later acquired by Perrigo, to formally submit its application to the FDA.

Supporters were especially intrigued by Opill due to its limited worries about safety. The US initially granted approval to this medication fifty years ago, however, it has not been made available in the market since 2005.

Blanchard from Ibsis Reproductive Health stated that this pill has been in existence for a significant duration and there is a substantial volume of evidence demonstrating its safety and efficacy for non-prescription utilization.

Modern contraceptive pills usually contain a combination of estrogen and progestin hormones, which aid in reducing the intensity and regularizing menstrual cycles. However, utilizing these pills raises the likelihood of developing blood clots and should be avoided by women who are prone to heart issues, including smokers over the age of 35.

Opill contains only a progestin hormone, which works by obstructing the movement of sperm towards the cervix, thus preventing pregnancy. For optimal effectiveness, it is important to take Opill at approximately the same time every day.

According to an examination conducted by the FDA and shared in May, there were certain women who participated in Perrigo's research study who encountered difficulties comprehending the medication's label details. Specifically, the guidelines caution against the pill's usage for women with a past occurrence of breast cancer, as it might stimulate the expansion of tumors. Furthermore, if women encounter atypical vaginal bleeding, they are instructed to consult a medical professional initially, as it could signify an underlying medical issue.

Perrigo officials announced that the company plans to dedicate the remaining period of the year to produce the medicine and its packaging, ensuring its availability in retail outlets and online platforms by the beginning of the following year.