A Win For Women: The First FDA Approved Non-Prescription Birth Control

On July 13th, the Food and Drug Administration (FDA) officially announced its approval of Opill (norgestrel), a non-prescription birth control. It will be the first over-the-counter birth control available to women in the U.S. in the 50 years since its debut. It will not only be available in drug stores, but also in supermarkets, convenience stores, and online stores. This product is a huge milestone in the expansion of contraceptive access, as well as a great tool for preventing unwanted pregnancies.

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Opill was produced by the pharmaceutical company Perrigo. Although the price of a one-month supply of Opill is yet to be released, the company has confirmed an early 2024 release. Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research declared in her statement, “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available non-prescription contraceptive methods in preventing unintended pregnancy.”

Opill’s mission is to provide an efficient and effective form of birth control that is easily attainable to the public. Although products such as condoms and spermicides are readily available without prescription, they are not as effective as birth control tablets in preventing unwanted pregnancies.

ACCESSIBILITY TO BIRTH CONTROL PILLS

Birth control was first introduced in 1960 and has only been available with a prescription since then.

Non-prescription birth control may be new to the U.S., but over 100 countries, including The United Kingdom, Mexico, and India, have a ready-for-consumption over-the-counter birth control option.

According to a national survey conducted by the American College of Obstetricians and Gynecologists (ACOG), 68% of the 1,385 women surveyed had tried to obtain a prescription for hormonal contraception. Of those 68%, 29% had problems accessing the initial prescription or refills.

Cost barriers and a lack of insurance are the main obstacles faced by women trying to receive birth control. Approving a non-prescription birth control option for women provides a solution to the issue of inaccessibility for people who have had trouble obtaining correct healthcare assistance.

OPILL IS A ONE HORMONE PILL

What makes Opill a safe birth control option is that, unlike many prescription birth control pills, it only contains one hormone, progestin. Progestin is a form of progesterone, a female hormone produced in the ovaries. Progestin-only pills help prevent pregnancy by making it difficult for sperm to enter the uterus, thins the uterine lining, and stopping ovulation for many women. If taken every day at the same time, the ACOG says that fewer than one in 100 women could get pregnant during their first year of taking progestin-only birth control pills.

Melissa Chen, an associate professor in the UC Davis Department of Obstetrics and Gynecology, explains that “Progestin-only pills are safer compared to combination birth control pills that contain both progestin and estrogen. Progestin-only pills don’t have the same risks of blood clots or stroke as combination pills.”

OPILL MAY NOT BE FOR EVERYONE

Although Opill has many advantages, no drug or intervention is completely void of any risk of harm. The FDA states that the most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, or bloating. Those who have or have had breast cancer are also warned against the use of Opill.

Consumers with any other form of cancer should consult a doctor to see if Opill is right for them. Opill should not be used in combination with any other hormonal birth control products (i.e., vaginal ring, contraceptive pill, patch, implant, or injection) or those taking specific medications (e.g., epilepsy medication or antibiotics for tuberculosis) that could negatively interact with the pill and decrease its efficacy.

Many doctors and experts also worry that with the approval of non-prescription birth control, patients will be less inclined to book checkup appointments. Over-the-counter birth control is not a replacement for regular doctor visits, nor does it protect against sexually transmitted diseases.

The ACOG clarifies that healthcare workers’ main concern with Opill, and the inevitable flood of other pharmaceutical companies looking to switch to non-prescription birth control products, is “a potential decrease in preventive screenings.”

PRODUCT SUPPORT AND DEMAND

However, the Women’s Health Practice and Research Network of the American College of Clinical Pharmacy supports the change from prescription to non-prescription oral contraceptives but has two major conditions. First, the pills must be sold with a pharmacist on duty to avoid mistreatment of pills. Second, mechanisms should exist to ensure a decrease in out-of-pocket costs for consumers.

Data from the National Survey of Family Growth state that oral contraceptives are the second-most used method among women. In a study done by Women’s Health Issues on the interest of an over-the-counter progestin-only pill in the U.S. Women, 39% of adults, and 29% of teens reported that they would likely use the product, especially if it was covered by insurance.

These statistics speak to how important a non-prescription birth control pill is to the U.S. The findings indicate a massive market for this product and improved progress toward making contraceptives much more accessible.

THE CULTURE AND FUTURE OF BIRTH CONTROL

There has always been a stigma surrounding women’s health, particularly birth control and abortion. With the recent overturning of Roe v Wade in 2022, body autonomy among women has become increasingly strict. Justice Clarence Thomas has argued that the Supreme Court should reconsider past rulings that have codified our right to access contraception.

After the Supreme Court and other politicians in states such as Ohio and Oklahoma have begun the process of stripping away our choice in bodily autonomy, there is great pressure now more than ever to meet the critical need for easily accessible contraceptive care. It is important for women to protect themselves from undesired pregnancies through full access to a range of contraceptive options. Young women who are new to sex especially need to be fully aware of their options.

MIXED MESSAGES MAY CONTINUE

Opill is a product that will not only provide a breakthrough in supplying accessible birth control to women but will also help in eliminating the stigma and misconceptions of contraceptives. Many cultures, including American culture, have negative views on birth control because of their belief that it promotes sexual activity among adolescents.

Many young women and teens are scared by society into rejecting these forms of healthcare and sex education to avoid being viewed as “promiscuous.”

Although for some people these ideas on sex and contraceptives may seem outdated, in states such as Iowa, where the state attorney general’s office announced the payment suspension of emergency contraceptives for sexual assault survivors because they want to “evaluate whether this is an appropriate use of public funds,” shows how these negative notions on sex are still apparent in our modern time.

There is also a fear of the side effects of birth control. I have heard horror stories of uncontrollable emotions, unpreventable weight gain, and intolerable nausea, and it has turned me and other women away from considering the pill as an option. However, after a full night of thorough research on Planned Parenthood and speaking with women who have had positive experiences with birth control pills, I learned that these side effects are not only common but often temporary. Fortunately, there are various brands and methods for women to try and choose from, with guidance from a healthcare professional.

It is also worth noting that in our society, the responsibility to prevent pregnancy often affects women. Careful attention added stress, and time taken to ensure safe sex without accidental pregnancy are disproportionately relayed to women much more than to men. Having non-prescription birth control will reduce stress, and time spent by women tends to be dealt with on a daily basis.

Prioritizing the health and safety of women is essential for our society to combat unintentional pregnancies. If birth control can be within reach for women, it could prove beneficial in dismantling the negative connotations surrounding contraceptives and positively promoting safe sex.

CONCLUSION

The introduction of Opill has proved to be a great success in the field of women’s health. With the substantial demand for non-prescription birth control pills by consumers and healthcare professionals alike, it is undeniable that there is vast potential for improving the way we receive birth control. Supporting the release of the first non-prescription oral contraceptive pill in the U.S. is the first step toward achieving a much simpler and widely accessible way of obtaining birth control.

Opill is just the beginning of over-the-counter birth control pills, making way for other pharmaceutical companies to adapt to the FDA’s rules and regulations to provide non-prescription birth control to the public. With more options inevitably coming into the market, the barrier between women and birth control will become obsolete. An increasing number of women will have the opportunity to protect themselves against unwanted pregnancy without the struggles of obtaining a prescription.