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FDA Recommends the First-Ever Over the Counter Birth Control

By: Kalani Phillips, MPH, CPH


A panel of advisers for the Food and Drug Administration (FDA) recommended that the agency approve the first-ever over the counter birth control pills in a 17-0 unanimous vote last month on May 10th, 2023. After 2 days of presentations by the birth control pills’ sponsor, FDA, scientists, and members of the public, the panel voted that the benefits of providing an over the counter birth control pill outweighed the risks. Considering that we are living in a post-Roe era, this move represents a win toward reproductive autonomy in the US. Our country is now moving closer to joining the list of more than 100 countries globally that offer oral contraceptives without a prescription.





The pill, Perrigo’s Opill (0.075 mg norgestrel), is a progestin-only birth control pill that was first approved for prescription use nearly 50 years ago. If the drug is approved for over the counter use, it could be sold at drugstores by 2024, if not sooner. However, the panel’s decision is not binding. The FDA is planning to decide this coming Summer whether to follow the decision, and it is highly likely since the vote was unanimous. Until then, the only over the counter birth control methods offered in the US are emergency contraceptives, male and female condoms, and spermicides.


Providing access to birth control pills without a prescription will significantly expand access to oral contraceptives across the nation, thereby impacting public health positively and granting individuals more control over their bodies and life course. Individuals throughout the US that may have difficulties obtaining health insurance, going to the doctor, or have constraints based on time, location, or costs, may be able to obtain birth control more easily with this policy.


There were some concerns that were raised about the safety of use in a nonprescription setting, in which some doctors worry individuals may not take the medication responsibly and/or follow the directions. That said, we live in a country where birth control pills and Opill have been approved and in use for nearly half a century, where people are trusted to take the pills on their own, so I think we can trust womxn to use the medication responsibly. The FDA panel even stated they have confidence in the effectiveness of the pill, even among populations with limited literacy or among adolescent populations.


After the overturning of Roe v. Wade in June 2022, access to birth control has become a salient public health concern to prevent unplanned pregnancy. However, while providing access to over the counter birth control pills will make contraception more conveniently accessible, cost may still be an issue. Currently, the Affordable Care Act only covers birth control that is prescribed, and although some states mandate that over the counter birth control methods be covered by insurance, most states do not have this policy. Only 13 states require over the counter birth control methods be covered by insurance. Even so, HRA Pharma, the company that owns Opill, has recently stated that they are committed to making the drug affordable to diverse populations.


This decision is a step in the right direction for the US healthcare system. If approved, the FDA can help address many structural barriers to accessing contraception in order to safely and effectively prevent unplanned pregnancies. According to the literature, approximately 19 million women currently live in contraceptive deserts, areas that lack health centers and lack access to a wide range of contraceptive methods. This fact highlights a need for better access throughout the nation. Additionally, unplanned pregnancy rates are higher amongst vulnerable groups, including low-income individuals, individuals that have not completed high school, and other groups that have been historically excluded. Recent research indicates that access to reproductive health care has become more difficult in recent years, in which individuals find it hard to get routine screenings or even prescription birth control from their provider. Considering the findings above, it is crucial that we trust womxn as well as provide safe and effective contraceptive methods conveniently for them. An unplanned pregnancy can abruptly change an individual's life, being able to obtain convenient and affordable birth control methods can help individuals have autonomy over their bodies, choices, and life course.






References:


Adler, A., Biggs, M. A., Kaller, S., Schroeder, R., & Ralph, L. (2023). Changes in the Frequency and Type of Barriers to Reproductive Health Care Between 2017 and 2021. JAMA Network Open, 6(4), e237461. https://doi.org/10.1001/jamanetworkopen.2023.7461



Gonzalez, O. (2023, May 10). FDA experts unanimously endorse over-the-counter birth control pills. AXIOS. https://www.axios.com/2023/05/10/fda-experts-endorse-birth-control-over-the-counter


Hassan, C. (2023, May 10). FDA advisers vote unanimously in support of over-the-counter birth-control pill. CNN Health. https://www.cnn.com/2023/05/10/health/over-the-counter-birth-control-fda-advisers/index.html


Hensley, S., & Stein, R. (2023, May 10). Advisers to the FDA back first over-the-counter birth control pill. NPR. https://www.npr.org/sections/health-shots/2023/05/10/1175255611/advisers-to-the-fda-back-over-the-counter-birth-control-pill


LACK OF ACCESS = LACK OF POWER TO DECIDE. (n.d.). Power to Decide. https://powertodecide.org/contraceptive-deserts


Lenharo, M. (n.d.). FDA advisers unanimously back over-the-counter birth control pill. Nature. https://www.nature.com/articles/d41586-023-01580-2


Phillips, D. (2023, April 10). Access to reproductive health care has become more challenging for women in the US, study shows. CNN Health. https://www.cnn.com/2023/04/10/health/reproductive-health-barriers-wellness/index.html


Rubin, R. (2023). Over-the-Counter Birth Control Pill Could Be Available in the US by Year’s End. JAMA. https://doi.org/10.1001/jama.2023.9497


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