August: The approval of Opill
Written by Sophia Allen
POint of View:
Why the FDA’s Approval of Opill Matters – And What’s Next
Having access to safe and affordable contraception is now more essential than ever. In an opinion piece, Dr. Carolyn Sufrin, MD, PhD (Associate Professor of Obstetrics and Gynecology at Johns Hopkins School of Medicine) discusses how timely and important the FDA’s decision to approve Opill is given the abortion restrictions in many states. Progestin-only birth control pills are safer than combination (progestin plus estrogen) pills, in fact “they are even safer than Tylenol”. Dr. Suffrin also hopes combination pills also become available over the counter. Along with corresponding education and risk-management efforts, both options will increase women’s control over birth control. Pharmacists will be key partners as they need to be able to relay accurate information to customers that come to them with questions.
The Biden administration has argued that cost of contraception should be covered; however, it is unclear if insurances will cover Opill and how much it will cost without insurance. Another concern is that laws enabling pharmacies to refuse to offer Opill could be passed by state governments that have already restricted access to abortion. We saw this happen when Walgreens refused to offer mifepristone, the first pill in a dose of two pills (the second being misoprostol) taken to terminate a pregnancy. Future shifts in federal administration could also impact the longevity of Opill’s success and hamper future efforts to increase contraception access. While this decision is very exciting, but we still have a lot of work to do to ensure contraceptives are equitably and sustainably available.
Resource:
OPILL FACT SHEET
Opill, often called the “mini-pill” because it contains progestin rather than a combination of estrogen and progestin, thickens the cervical mucus, preventing sperm from reaching the uterus. The pill, like other birth control pills, is 98% effective if taken at the same time every day (as intended) and has been found to have fewer side effects than combination pills. Those who have or have had breast cancer should not use Opill.
The Opill factsheet is a 1-page flyer including critical facts about Opill, including its effectiveness in preventing pregnancy, safety, and directions for use. The factsheet also includes a timeline of Opill’s history, from its original approval date in prescription pill form (1973) to its approval for OTC use in the US (2023) and intended availability in stores and online (2024). Lastly, the flyer covers potential side effects and links to additional resources for those who want to learn more.
News Story:
New York Times - Women React to News About an Over-the-Counter Birth Control Pill
Following the approval of Opill, the New York Times interviewed 18 women about their thoughts concerning the FDA’s landmark decision with mixed reactions. Teenagers mentioned that the pill benefits those with conservative parents or parents whose culture was less accepting of birth control. People of all ages cited convenience as the primary draw of an OTC pill. Alternatively, some had concerns about safety and side effects, the FDA’s choice not to impose age restrictions, or that one could procure the pill without medical guidance. For people who find providers are hard to reach or whole providers do not manage birth control, this was a good development. Although Perrigo (the manufacturing company that produces Opill) claims they are committed to keeping Opill “affordable,” a price has not yet been announced. Universal access to the pill does not mean that everyone who wants to buy the pill will feel
empowered, comfortable, or educated enough to buy it or be able to afford it. More will need to be done to ensure equitable access for all regardless of income or health insurance.
Scientific Publication:
Interest in Using Over-the-Counter Oral Contraceptive Pills: Findings from the 2022 KFF Women's Health Survey
In 2022 (before the approval of Opill), Kaiser Family Foundation conducted a nationally-representative survey, including 5,201 women ages 18 to 64, on the acceptability of OTC birth control pills. Three-quarters (77%) of women supported OTC birth control pills if they were proven safe and effective, with over half (56%) indicating their strong support, and 39% said they would be likely to use the pill. Not having plans to use any contraception was the most common reason reported for not being likely to use the pill.
Notably, of those who said they would use the pill, only one-sixth of people said they would pay more than $20 per pack. Additionally, many survey results varied based on demographic factors, including race, ethnicity, income, insurance status, and history of birth control use. For instance, confidentiality as a primary reason to use Opill was cited twice as often by Black survey respondents compared to White respondents (10% vs. 5%), despite overall support ratings for Opill being lower among Black respondents than any other racial/ ethnic group (including White, Hispanic, and Asian/Pacific Islander). This and other differences in perspectives on birth control (as well as factors such as how or at what age one should obtain birth control) allude to the impacts of structural medical racism and other interlocking oppressions that lead to unequal rates of unwanted pregnancy and subsequent poor outcomes for women.
