FDA approves first nonprescription, OTC oral contraceptive pill
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Key takeaways:
- FDA approved norgestrel as the first daily oral contraceptive to be available over the counter, without a prescription.
- Norgestrel is safe and effective to prevent pregnancy if taken at the same time daily.
The FDA today approved a progestin-only pill as the first nonprescription daily oral contraceptive to prevent pregnancy.
The approval of norgestrel (Opill, HRA Pharma) provides an option for women to purchase an oral contraceptive pill without a prescription at drug stores, convenience stores, grocery stores and online, according to an FDA press release. Norgestrel should be taken at the same time daily for best effectiveness for preventing pregnancy.
“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the press release. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”
Norgestrel was originally approved for prescription use in 1973. HRA Pharma applied to the FDA to switch from prescription to over-the-counter approval. In May, two FDA advisory committees judged that norgestrel can be used by women safely and effectively by relying solely on the nonprescription drug labeling without assistance from health care professionals. Studies of norgestrel as an OTC pill showed that consumer understanding of its drug facts label was high and that most consumers understood the label’s instructions.
The timeline for norgestrel availability and price will be determined by the manufacturer while other approved prescription formulations and doses of other oral contraceptive pills will remain available, according to the release.
Perspective
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As a practicing OB/GYN who has dedicated her life to working on methods to increase access to care for women globally, I think the availability of an over-the-counter oral contraceptive pill in the United States is a step in the right direction when it comes to women and reproductive health options. First, I am a woman who believes in reproductive rights and choice and, second, a physician who believes in patient and physician autonomy. So, this recent development of an FDA-approved OTC oral contraceptive pill feels like a significant milestone.
As long as it is a safe and effective method and the patient understands the risks, benefits and potential side effects, this OTC oral contraceptive pill can be a great option for many women. However, I do not believe that this should be the first thing a person reaches for without a thorough discussion with their health care provider such as their OB/GYN. The newly FDA-approved OPill, as with similarly formulated oral contraceptive pills, needs to be taken around the same time daily to be effective. If it isn’t, the method can fail and the person should use a backup contraceptive method. In addition, this pill, like many others, does not protect someone from sexually transmitted infections. If sexually active, people should still take measures to protect themselves from STIs, for example, by using barrier contraception methods (ie, condoms).
All medications and treatments come with potential side effects and risks; however, based on the data available thus far, I believe the benefit, if the drug is widely available and affordable for people, is substantial. This can potentially reduce barriers to access, improve adherence and help to give people more control of their reproductive health.
Perspective
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This approval benefits everybody, first and foremost because it removes barriers to care, such as lack of insurance or trying to schedule a doctor appointment but no appointment is available before the prescription expires. This approval definitely improves that sort of barrier. This approval also benefits teenagers who may not want family members to know that they are trying to access health care. Hopefully, this helps more teens who are interested in accessing appropriate contraception.
My only concern about barriers to access is what the price point will be. Right now, when insurance pays for this pill, the copay can be as low as no fee or $1. More than that can start to be prohibitive for many people.
This approval is for a progestin-only pill, so there are very few contraindications. Study after study has shown that people are completely capable of self-screening for those very few contraindications. This is a safe option.
The American College of Obstetricians and Gynecologists put out committee opinions back in 2019 that were reaffirmed in 2021 saying that there is a place for OTC contraception, so this is something we’ve always pushed for.
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