At Issue: Access among benefits of nonprescription OTC contraceptive pill

Key takeaways:

• Opill was approved as a nonprescription, OTC daily oral contraceptive in July.
• Information on appropriate use and medication precautions should be reviewed carefully by consumers.

In July, the FDA approved norgestrel as the first nonprescription, over-the-counter daily oral contraceptive to prevent pregnancy.

Previously, norgestrel (Opill, HRA Pharma) was approved for prescription use in 1973. In May, several FDA advisory committees reported that norgestrel can be used safely and effectively through reliance solely on the nonprescription drug labeling without health care professional assistance.

Norgestrel should be taken at the same time each day for best effectiveness in preventing pregnancy. The approval provides an option for people to purchase norgestrel at drug stores, convenience stores, grocery stores and online without a prescription.

Healio spoke with experts in women’s health regarding the importance and possible challenges of having a nonprescription OTC oral contraceptive.

Frank B. Williams, MD

On July 13, the FDA for the first time granted approval for nonprescription use of a hormonal daily contraceptive. Opill is a norgestrel-containing pill that will be sold OTC, eliminating key barriers to an effective form of birth control. Nearly half of U.S. pregnancies are unintended; increases are expected following implementation of laws limiting access to reproductive services in the wake of the Dobbs decision. A recent peer-reviewed article from HRA Pharma, the manufacturer, comparing current birth control strategies to a modeled effectiveness of OTC norgestrel demonstrated a dramatic potential reduction in unintended pregnancies for people using Opill.

While OTC hormonal contraceptives have long been available outside the U.S., the recent approval marks a shift for the FDA. Prior obstacles have included safety concerns, but in this case, 50 years of demonstrated norgestrel effectiveness and safety in the prescription setting is reassuring. Absolute contraindications, such as breast cancer, are rare and generally understood by those diagnosed with them. Critically, even for those with contraindications, exposure to norgestrel contraceptives likely poses less risk than the alternative of pregnancy.

For the Opill to have intended success, it must be accessible. The cost of the drug has yet to be set by the manufacturer. High prices would limit access and insurance plans are not required to cover OTC contraceptives. Inequitable distribution would limit access even to a reasonably priced drug. For instance, independently owned pharmacies are less likely to stock OTC emergency contraceptives compared to commercial pharmacies. In New Orleans, where I practice, nearly two-thirds of pharmacies serving the lowest-income neighborhoods are independent. To reach those communities, independent pharmacies would need to carry the OTC contraceptives.

Regardless of potential challenges, expanding options for birth control marks a key win for women and families looking to prevent pregnancies.

Williams is a maternal and fetal medicine specialist at Ochsner Health in New Orleans.

Maria Coyle, PharmD, FCCP, BCPS, BCACP, CLS

The approval of Opill for OTC use is noteworthy, as it places a highly effective, oral daily contraceptive in the nonprescription marketplace for the first time. Challenges to obtaining reliable, oral birth control methods are encountered daily by those who wish to avoid becoming pregnant, particularly for lower-income and younger women. Many are not able to get effective, reliable birth control or use other methods of birth control, resulting in unintended pregnancies and unmet public health needs for individuals, families and society.

For those interested in Opill, information on appropriate use and medication precautions should be reviewed carefully, so that the product will serve consumers well. Opill is a progestin-only product — unlike many of the prescription oral contraceptives which combine an estrogen and progestin for prevention of pregnancy — which means it can be ideal for those without regular access to health care visits, those who breastfeed or those who should otherwise avoid estrogen-containing medications. This also means that adherence is so important. Opill must be taken daily at the same time each day and without interruptions between pill packs; delaying or skipping doses can make it much less effective and increase likelihood of unintended pregnancy.

Patients with a history of breast cancer should not use Opill; and those with unexplained vaginal bleeding should consult a health care provider prior to use.

For those who wish to switch from their current prescription contraceptive to Opill, it is a good idea to consult your physician or pharmacist before making the change. You will want to understand key differences between products and any potential drug interactions with Opill and other medications. It may also be helpful to compare costs between prescription products and Opill before deciding on a change. Insurance coverage for prescription and OTC oral contraceptives may evolve in the coming months as we have seen with other Rx to OTC switches.

Coyle is an associate professor of clinical pharmacy education and innovation at the College of Pharmacy at The Ohio State University.

Kate Grindlay, MSPH

Progestin-only pills are safe and effective for nearly everyone who would like to use them. A large population is interested in using over-the-counter progestin-only pills, mainly due to saving time and money from not needing a clinic visit and being able to start it when they wanted to.

In our nationally representative survey, 39% of adults and 29% of teens said they would likely use an OTC progestin-only pill. Uninsured individuals and those currently using oral contraceptives were among the most interested; however, nearly one-quarter of those not currently using any method at all and approximately 40% using a less effective method reported they would use a progestin-only pill that was available OTC.

We conducted a study with people who used the progestin-only pill, Opill, OTC in a trial setting to learn more about their attitudes and experiences. We found that the vast majority of these Opill users (83% of both adults and teens) wanted to continue using it once available on the shelves, with Latinx and Black participants and adults with public insurance, prior pregnancies and some college reporting higher likelihood of future use compared to their counterparts. Having previously experienced contraceptive access barriers also contributed to participants' interest in OTC Opill use. Similar to prior research, the main drivers of interest in OTC Opill among those who had used it in a trial setting included its convenience, ease of access and saving time and money.

Also of note from our study, 72% of participants were not using any contraceptive method or were using a less effective method in the month prior to the trial. The use of an OTC oral contraceptive pill in a trial setting among these individuals highlights the potential public health relevance and benefit that OTC availability may have in increasing contraceptive access for individuals who currently face barriers, including teens who often face additional and unique access barriers. When it is on shelves in a few months, Opill will be the most effective contraceptive method available OTC.

While OTC access is a game changer and will advance public health, in order to support equitable access, Opill must be priced affordably and fully covered by insurance. We found adults and teens will pay up to $10 to $15 per pill pack, and that interest was highest if the product was covered by insurance.

Grindlay is a research consultant at Ibis Reproductive Health.

Asima Ahmad, MD, MPH, FACOG

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.

Ahmad is the chief medical officer and co-founder of Carrot Fertility.

LeeAnn Tanaka, DO

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.

Tanaka is a family medicine specialist and assistant professor of family medicine at the Philadelphia College of Osteopathic Medicine.