The Food and Drug Administration (FDA) has made a significant change in access to oral contraception by approving a birth control pill that will be available without a prescription. Called Opill, this over-the-counter (OTC) contraceptive will be the first of its kind in the United States.
Experts believe that this development could be a game-changer for individuals who do not want to become pregnant. By eliminating barriers and providing easier access to contraception, Opill aims to reduce the number of unintended pregnancies in the country.
Opill, manufactured by Perrigo, will be available online and in retail stores starting in the first quarter of 2024. This FDA approval marks a groundbreaking expansion of women’s health in the U.S. and addresses an essential need for wider contraceptive access, according to Frederique Welgryn, Perrigo’s Global Vice President for Women’s Health.
Opill contains the hormone norgestrel, which was initially approved by the FDA as a prescription contraceptive in 1973. Perrigo applied to switch the medication from prescription to OTC status a year ago. The FDA evaluated the medication’s safety and effectiveness without the need for assistance from a healthcare professional, concluding that Opill can be used safely and effectively.
According to the FDA, nearly half of the 6.1 million pregnancies in the United States each year are unintended. Opill’s approval is expected to expand access for those who struggle to make or wait for a doctor’s appointment. It is approved for users of any age, eliminating age restrictions and allowing more individuals to benefit from OTC contraception.
Yasaswi Kislovskiy, Director of Reproductive Infectious Disease for Allegheny Health Network, calls this development huge. She emphasizes that many people face barriers to obtaining a prescription for birth control and believes that making it available without a prescription can have a significant positive impact.
While the exact availability and display of Opill in pharmacies and stores are still unknown, Kislovskiy hopes it will be easily accessible, much like other OTC medications. Ideally, individuals looking to prevent pregnancy can simply pick it up from the medication aisle and proceed to check out.
To ensure its maximum effectiveness, Opill should be taken at the same time every day. In perfect use, the medication is 98% effective in preventing pregnancies. However, with typical, inconsistent, or incorrect use, its effectiveness drops to 80% or 90%.
It’s important to note that Opill is not an emergency contraceptive and cannot prevent pregnancy after unprotected sex. Individuals with a history of breast cancer should not take Opill, and those with any history of cancer should consult their doctor before use. Opill should also not be used in combination with any other form of hormonal birth control.
The approval of Opill comes at a time when some states have limited or eliminated access to abortions due to the Supreme Court’s Dobbs vs. Jackson’s Women’s Health Organization ruling. Dr. Kislovskiy believes that the availability of OTC contraception empowers individuals and gives them more control over their reproductive choices.
In conclusion, the FDA’s approval of Opill represents a significant step forward in improving contraceptive access. By making a daily birth control pill available without a prescription, this development aims to reduce unintended pregnancies and empower individuals in their reproductive health decisions. With Opill set to hit the market in early 2024, its availability could mark a positive change in how birth control is obtained and utilized.
