By: Abigail Palotas, Staff Writer
Photo courtesy of Pixabay.com
In July 2023, the U.S. Food and Drug Administration (FDA) approved Opill tablet for nonprescription use to prevent pregnancy.[1] Opill is the first daily oral contraceptive approved for nonprescription use in the U.S.[2] Opill is a progestin-only as opposed to an estrogen-progestin combination pill.[3] Many people who cannot take estrogen-progestin pills can safely use Opill, including those with high blood pressure, diabetes, and cardiovascular disease.[4] However, Opill should not be taken by anyone with a history of breast cancer or certain rare types of liver disease.[5]
The most common side effect of Opill is irregular spotting.[6] According to Patrizia Cavazzoni, M.D., who serves as director of the FDA’s Center for Drug Evaluation and Research, daily oral contraception is safe and is expected to be more effective than other nonprescription methods in preventing unintended pregnancy.[7] When used as directed, meaning Opill is taken every day at the same time, Opill is 98 percent effective.[8] Importantly, Opill is not for use as emergency contraception and does not protect against transmission of sexually transmitted diseases.[9] Following FDA approval, as of March 2024, Opill is available online and on store shelves across the U.S.[10]
In 2016, the Free the Pill movement began working with states to enact over-the-counter (OTC) contraceptive coverage laws.[11] The Free the Pill Movement advocates for birth control pill accessibility.[12] A prescription requirement is just one barrier among many to birth control pill access. Other barriers include not having a regular healthcare provider, the time visiting a provider takes away from school or work, transportation to the provider’s office, cost of a provider visit, lack of insurance coverage, and parental consent requirements.[13] Today, eleven states have laws requiring insurance coverage for OTC contraceptives.[14] Those states are: California, Colorado, Delaware, Illinois, Maine, Maryland, New Jersey, New Mexico, New York, Oregon, and Washington.[15]
There are two main considerations in OTC contraceptive coverage laws: (1) the type of insurance plan and (2) the types of contraception covered.[16] State laws apply to certain types of insurance plans, including individually purchased plans, some employer plans, Medicaid, and state employee plans.[17] However, other types of insurance plans, especially large employer plans and Medicare, are governed by federal rules.[18] Some state regulations and policies, particularly for Medicaid coverage, may still need to be updated for Opill.[19]
When it comes to the types of contraception covered, state OTC coverage laws distinguish between medications (Opill and emergency contraception, such as Plan B) and devices (internal and external condoms).[20] All eleven states with OTC coverage laws cover OTC medications, although New York’s state law may need to be updated to guarantee that Opill will be covered.[21] Seven of the states cover all OTC contraceptive devices as well.[22] Illinois covers some OTC contraceptive devices but excludes male (external) condoms since these are the most common type of contraceptive device.[23] While a few states may have to update their laws to ensure coverage of Opill, as indicated above, most state laws are flexible enough to provide coverage of any future OTC contraceptive products without the need for statutory updates.[24]
A small but growing number of people now have OTC birth control coverage under state policies, but the majority of people are covered by insurance plans that still require a prescription for birth control.[25] Research shows that cost is a significant barrier to accessing OTC birth control pills; one study found that half of adults and teens interested in using OTC birth control pills would be able to pay $10 or less per month for them.[26] Therefore, insurance coverage of OTC birth control pills plays a crucial rule in continuing to expand the availability of birth control.
[1] https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive
[2] Id.
[3] https://nyulangone.org/news/five-things-know-about-opill-first-fda-approved-over-counter-birth-control-pill
[4] Id.
[5] Id.
[6] Id.
[7] https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive
[8] https://nyulangone.org/news/five-things-know-about-opill-first-fda-approved-over-counter-birth-control-pill
[9] https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive
[10] https://freethepill.org/the-movement
[11] https://freethepill.org/resources/states-with-over-the-counter-contraceptive-coverage-laws
[12] https://freethepill.org/the-movement
[13] Id.
[14] https://static1.squarespace.com/static/624f47211382a25c48aca17d/t/689cb5cbca5a475cf759c1d3/1755100619053/Free+the+Pill+State+OTC+Fact+Sheet+_8.13.25.pdf
[15] Id.
[16] Id.
[17] Id.
[18] Id.
[19] Id.
[20] Id.
[21] Id.
[22] Id.
[23] Id.
[24] Id.
[25] https://static1.squarespace.com/static/624f47211382a25c48aca17d/t/673e5e03a3c5fa4e3492c4d3/1732140547844/Free+the+Pill+and+Cover+it+Too_OTC+Contraceptive+Coverage+Collaborative_Implementation+Report_11.20.2024.pdf
[26] Id.