Some Durango health providers have lauded the U.S. Food and Drug Administration’s approval of Opill, an oral birth control pill containing norgestrel, last month for over-the-counter sales without prescription requirements. Some concerns remain, though.
The price of the pill, yet to be disclosed by its manufacturer, Perrigo, could affect its accessibility. The pill also requires strict daily use to be effective at preventing pregnancy.
Before July 13, no contraceptive has ever been approved for non-prescription sales in the United States. Health professionals consider the FDA’s decision a win for reproductive rights after a string of losses locally and around the country.
Mercy Hospital in Durango, for example, nixed tubal ligations at the time of cesarean sections in April. Also, the U.S. Supreme Court’s decision last summer to overturn Roe v. Wade resulted in at least 21 states implementing restrictions or outright bans on abortion.
But over-the-counter birth control is a powerful development, Southwest Women’s Health Associates owner and nurse practitioner Karen Zink said.
Amanda Araujo, a nurse practitioner who partners with Zink at Southwest Women’s Health, said it’s exciting another contraception option will soon be available to people who want to prevent pregnancy.
“Especially in this time when there are so many more limitations (being) added in,” she said.
Planned Parenthood of the Rocky Mountains President and CEO Adrienne Mansanares said the FDA’s decision is a nice moment amid an onslaught against reproductive and sexual health in different states.
“It’s really nice to be happy in this moment and to have something exciting, to know that there are ways that we can open up this care for others, especially in this very political environment,” she said.
Opill is expected to hit the shelves for over-the-counter purchase in early 2024, according to the FDA. However, one question remains that could impact people’s ability to access the contraceptive: How much will it cost?
The FDA says the price of Opill will be up to the pill’s manufacturer, which has not yet announced price points.
Lori Kearney, owner of RiverGate Pharmacy in Durango, said the price of Opill will definitely affect accessibility. If the pill isn’t offered at reasonable and affordable prices, it won’t be as promising a contraceptive for women who can’t afford it.
“I am hopeful that it will be less expensive than any prescription birth control that they can get,” she said.
It is hard to pinpoint what a reasonable cash price point would be compared to prescription birth control, because many prescriptions are dispensed through patients’ insurance, Kearney said. Patients’ copays vary widely, and prices differ based on the kind of birth control that’s being purchased.
“There are some (contraceptives) that women will take daily for three months and then go off of it for a week. Those are definitely more expensive than others,” she said.
Araujo said she hopes the market price for Opill helps accessibility, especially because people who want to prevent pregnancy already face many barriers.
“I just would hate to see another option that feels out of reach for people who can't afford it,” she said. “It should be inexpensive.“
There is another concern health professionals have about any new prescription drug hitting the over-the-counter market, and that’s education about how to properly use it, Kearney said.
“As a pharmacist, I’m always cautious when any prescription medication gets approved for over-the-counter use because not everyone will do their research to confirm that the medicine is safe and effective for them,” she said.
In the case of Opill, it’s one of the safest forms of oral birth control one can take, she said. But people still need to do their research and pay attention to instructions for taking it correctly.
Zink, who shares Kearney’s concern, said patients must take Opill on a stringent schedule in order for the contraceptive to work.
“If they take it every day, every single day, regardless of whether they’re bleeding (menstruating) or not, it can be pretty effective,” she said.
The sole active ingredient in Opill is norgestrel, Zink said. The pill doesn’t contain estrogen like other birth control pills, which can cause complications such as blood clots. Zink stressed that even if Opill contained estrogen, possible side effects would still be safer for women than pregnancy.
The main side effect Opill could cause is irregular bleeding – usually not heavy bleeding – but regardless of one’s menstrual cycle, the pill needs to be taken consistently every day to work, she said.
“Women need to be educated so that they do take it properly,” Kearney said.
She said there is a grace period for missing a dose of just three hours. Health professionals recommend using a backup form of birth control for several days if one misses her daily dose.
It is not completely clear where Opill will be available over-the-counter locally once it hits the market next year.
Kearney plans to offer it at RiverGate Pharmacy. She said she sees no reason not to, adding an over-the-counter birth control option is important for all women.
Megan Boyd, senior manager of retail communications for Walgreens, said in an email, “Following the FDA’s approval and once commercially available, Walgreens will offer the over-the-counter birth control Opill as local communities’ most convenient health and wellness destination.”
Corporate representatives for pharmacies at Albertsons, City Market and Walmart did not respond to written requests for comment about whether Opill will be offered at those locations.
Staff members at Fort Lewis College’s Student Health Center declined to comment about the subject. Rene Klotz, nurse practitioner and clinical director of the health center, did not respond to emails requesting comment.
A spokeswoman for FLC said she was unsuccessful in reaching anyone who could discuss the FDA’s decision or if the college would provide Opill through its health services.
Axis Health Systems, which provides family planning and sexual health services, including contraceptives, responded to an initial inquiry by the Herald but ultimately did not provide a comment about whether it will provide the over-the-counter birth control pill.
Mansanares, CEO of Planned Parenthood of the Rocky Mountains, said she is thrilled with the FDA’s decision because it will improve access to contraception for people who need it immediately and may not have time to make an appointment. However, she isn’t sure if Opill will be offered through PPRM’s 20 Colorado facilities, including the Durango location.
“You know, we still haven’t made that decision,” she said. “I want to take a look first at those price points. Make sure it makes sense for patients.”
Planned Parenthood’s health centers operate like pharmacies with providers on site. So, the organization itself might not have to carry Opill in order for its patients to access it, she said.
FDA spokesman Jeremy Kahn said in a statement HRA Pharma, now owned by Perrigo, has been working with the FDA on a nonprescription development program since 2015.
On June 14, 2022, HRA Pharma “submitted a supplemental application for a full prescription-to-nonprescription switch of the product,” he said.
"On October 13th, 2022, HRA submitted a major amendment to the supplemental application,“ he said. “On May 9th and 10th, 2023, a public Advisory Committee meeting was held, at which certain challenging issues of the application were discussed.“
The FDA’s decision to make Opill available over the counter says the benefits of doing so to help consumers prevent unintended pregnancy and its medical, economic and societal harms outweigh potential risks of the pill in a nonprescription setting.
Araujo said she has no clue why the FDA’s decision came about this year and not sooner, but added “it always has to do with control” when it comes to reproductive health.
Mansanares said she doesn’t know what provoked the FDA’s approval of over-the-counter birth control in July.
“What I do know is that there were community-based organizations that had been working on this for literally decades,” she said. “And so things take a long time at the federal level, but when they are approved, they can have a tremendous impact.”