In a model based on a national survey of 2,539 reproductive-age women in the United States, an over-the-counter, progestin-only contraceptive pill would appeal to 12.5 million adults and 1.75 million teens, assuming there were no out-of-pocket costs.1

“We convened a coalition of researchers and advocacy organizations that support moving a birth control pill over the counter [OTC] — both progestin-only and combined pills,” says Alexandra Wollum, MPH, senior project manager with Ibis Reproductive Health in Cambridge, MA.

Other than barrier contraceptives and emergency contraception, there are no over-the-counter birth control methods available in the United States. More than 140 countries offer OTC birth control pills. (More information is available at: https://www.reuters.com/article/us-birth-control-pill/most-countries-offer-the-pill-over-the-counter-idUSBRE9010FQ20130102.)

The Food and Drug Administration (FDA) would need to approve OTC contraception under the OTC Monograph Process or the New Drug Application (NDA) process. A sponsor seeking to market a product as OTC applies to the Division of Nonprescription Drug Products (DNDP) in the Office of Drug Evaluation IV. (Find out more at: https://www.fda.gov/drugs/how-drugs-are-developed-and-approved/over-counter-otc-nonprescription-drugs#:~:text=Over-the-counter%20(OTC,Office%20of%20Drug%20Evaluation%20IV.)

“Each pill formulation should be submitted to be over-the-counter, one at a time, given the FDA process. We believe the progestin-only pill is most likely to be OTC first,” Wollum says.

Progestin-only pills are effective at preventing pregnancy, but are safe for more people because there are fewer health conditions for which the pill is unsafe, she says.

“Progestin-only pills and combined pills are very safe. But because progestin-only pills don’t have estrogen, they don’t have complications of stroke, heart attack, and blood clot. They’re safer for the broader population to take,” she adds.

Ibis Reproductive Health partnered with a pharmaceutical company to conduct research about bringing a birth control pill OTC. “We hope in three to five years this will be possible, and we’re excited about that potential,” Wollum says.

The chief benefit of an OTC contraceptive pill would be accessibility. “Access to affordable birth control is really important to the health and well-being of people and families,” Wollum says.

Contraceptive access issues have been exacerbated during the COVID-19 pandemic. “This moment has highlighted the need for over-the-counter birth control,” she notes.

Research shows that requiring people to obtain a medical prescription for birth control pills is a steep barrier for people with limited financial resources. For example, even if the birth control pill is covered through Medicaid or insurance, the patient might have to pay for a doctor’s visit, take time off work, and get child care, she explains.

It would improve contraceptive access if a person could pick up a birth control pill at a grocery store or pharmacy without a prescription — especially if it were covered by insurance or at an affordable retail price, Wollum says.

“Our hope is that an over-the-counter birth control pill would be affordable,” she adds. “From another study we’ve conducted, the median price people are willing to pay is $15. Among younger teens, it’s $10 per month.”

The study’s results reveal that among a population of adults at risk of unintended pregnancy, 38.5% were interested in using an OTC progestin-only pill, provided it has no out-of-pocket cost. If there was a cost for the OTC pill, then the percentage of people who would use it dropped.1

While an OTC progestin-only pill would be simple to use, consumer education is needed. “For any pill to be available over the counter, people have to follow directions on the package,” Wollum explains. “There are great resources online that people can access, and we do think people are able to read and assess when the pill might be right for them, and then follow the directions for the product.” People also can access information about contraceptives online and through advice from pharmacists and providers.

The researchers concluded a low-to-no-cost progestin-only pill available OTC would provide equitable access for low-income populations across the United States, and it would fill in gaps in contraceptive access.1

“I think this research is really encouraging and really supportive of a progestin-only birth control. It highlights the need for an equitable price to help people control their health and their lives,” Wollum says.

REFERENCE

  1. Wollum A, Trussell J, Grossman D, et al. Modeling the impacts of price of an over-the-counter progestin-only pill on use and unintended pregnancy among U.S. women. Women’s Health Iss 2020;30:153-160.