A national coalition is working to protect women’s access to contraception by paving the way for a ground-breaking change — selling “the pill” next to pain relievers, cold medicine, and allergy relief medications.
The coalition, which is organized by nonprofit Ibis Reproductive Health, has spent more than 10 years on the effort, and their goal might soon become a reality: Ibis, in partnership with a pharmaceutical company, is preparing to submit an application to the Food and Drug Administration (FDA) for over-the-counter status for progestin-only oral contraception.
“This is the rational thing to do,” said Britt Wahlin, Vice President of Development and Public Affairs at Ibis, which focuses on sexual and reproductive health research. “There’s no need for the prescription to hold up women’s access.”
The campaign is revolutionary for the U.S., yet more than 100 countries already sell oral contraceptives on pharmacy shelves. The United States lags behind its peers and even behind research showing U.S. women are able to determine whether birth control pills are safe for them to use — and to use them effectively.
Countries have over-the-counter access to the pill
If the FDA application goes through, it could herald yet another watershed moment in the battle for better reproductive health care. However, a key issue for Wahlin as she and her colleagues push forward with the application is making sure that if the pill goes over-the-counter, it’s still covered by insurance and is available to people of all ages.
So Ibis and the coalition have also been lending support to state advocates working to expand insurance coverage for contraceptives at the state level. And despite rollbacks to women’s health care in other regions, Maryland, New Mexico, and Oregon have passed legislation that strengthens existing mandates requiring insurers to pay for contraception by expanding it to include over-the-counter methods.
Wahlin said that when the emergency contraception pill Plan B moved over the counter about a decade ago, the retail price was high (the cost of Plan B and generics still ranges from $35 to $50), and some women who previously had been able to get it for free through Medicaid were unable to afford it.
‘The whole point of over-the-counter access is that you don’t have to have the step of getting a prescription,” Wahlin said. “So what we’ve been working toward [for oral contraception] is a model where there is insurance coverage and a prescription is not required.”
If Ibis’ efforts only “increase access for people who already have it, instead of benefiting people who face the greatest barriers to obtaining the birth control they want and need, that wouldn’t really help us achieve our goal,” she added.
This is the rational thing to do. There’s no need for the prescription to hold up women’s access.Britt Wahlin Vice President of Development and Public Affairs at Ibis
A survey conducted by the nonprofit showed almost a third of women who have tried to get birth control faced difficulties securing a prescription or a refill. Other studies have found that women encounter a number of barriers preventing them from using oral contraceptives, including long wait times to get an appointment at a doctor’s office and the inability to cover the cost of a visit, or to take time off from work or school.
Based on other nationally representative research, the organization estimates up to 11 million women and one in four women and teens who are not currently using contraception might use an over-the-counter pill if it were available.
“We know that women want this,” said Kate Grindlay Kelly, Ibis associate and director of Ibis’ Free the Pill initiative.
But demand hasn’t translated into enough of a financial incentive for the large pharmaceutical companies that dominate the marketplace to invest in an over-the-counter pill on their own, according to Wahlin, which is why the national coalition support has been so critical to furthering the idea.
It’s also why Ibis has partnered with HRA Pharma, a smaller, progressive company focused on women’s health, instead of a large organization, to apply for over-the-counter status for the pill. HRA shares Ibis’ desire to make it easier for women to start and use birth control, Wahlin said — so much so that it was willing to carry out the extensive research required by the FDA and spend up to five years shepherding a “switch” application through the agency.
As the process drags on, the coalition remains focused on the end goal. What Wahlin and Kelly envision is a day when all people are able to use the method of contraception that works best for them — a day when starting birth control is as easy as walking into the local pharmacy, bodega, gas station, or supermarket.
Although cuts to other programs and women’s health services might loom, Kelly said that she takes heart in the fact that theirs is “a proactive mission to expand access to essential health care.”
This is “something that moves us forward,” she said.
About the FDA approval process
Ibis Reproductive Health and its manufacturing partner HRA Pharma are in the midst of doing the research required for applications to the Food and Drug Administration to switch pharmaceuticals from prescription to over-the-counter. It usually takes between three and five years to complete the application, said Kate Grindlay Kelly, director of Ibis’ Free the Pill initiative. There are three key elements:
Label comprehension study: The label comprehension study tests people’s ability to read the label on the back of an over-the-counter product and determine the conditions for appropriate use, as well as who should take the product and how to do so. Applicants must demonstrate that people from a range of ages and backgrounds understand the directions for use.
Self-selection study: The self-selection study is intended to gauge people’s ability to screen themselves for use of the product. Applicants must show that someone can determine from reading the box whether they’re an appropriate user.
Actual use study: The actual use study tracks people over several months to determine whether they take the product correctly. For oral contraception, this means assessing whether people are taking the birth control pill daily and understand what to do if there is a gap in their use.
As HRA continues to wade through the long approval process, the regulatory landscape continues to shift: A series of bills allowing pharmacists to both prescribe and dispense oral contraception and telemedicine advances allowing women online access to a health care provider outside of a brick-and-mortar office are being introduced across the country, begging the question from some whether over-the-counter access is still necessary.
Kelly says yes. The policies are an exciting development, but women would still have to go through multiple steps to get a pill that is safe and effective for over-the-counter use. Furthermore, these advances have to be passed in a state-by-state fashion, whereas an over-the-counter pill would be a nationwide change.
What Ibis and its partners envision is a day when all people are able to use the method of contraception that works best for them — a day when starting birth control is as easy as walking into the local pharmacy, bodega, gas station, or supermarket.
And amid the Trump administration’s attempts to erode women’s health care services and shift federal money away from evidence-based family planning programs, Kelly said that she takes heart in the fact that theirs is “a proactive mission to expand access to essential health care.”
Rollbacks might loom in other areas; however, this is “something that moves us forward,” she said.