The first over-the-counter (OTC) birth control pill in the U.S. will hit the market soon, and the Biden administration is facing pressure from Democrats and reproductive health groups to make sure it is affordable.
The manufacturer of Opill says it’s on track to make the drug available sometime during the first quarter of this year, meaning it could be on shelves by March.
Reproductive health experts say making birth control pills available without a prescription has the potential to be a game changer, especially for younger women and those in rural and underserved communities.
It is more than 90 percent effective at preventing pregnancies, making it more effective than other OTC contraceptives such as condoms or spermicides.
The push to make birth control available OTC has been happening for years, but after the Supreme Court overturned Roe v. Wade and ended the constitutional right to an abortion in 2022, the movement took on more urgency.
The White House last week unveiled new efforts to expand access to contraception, including requiring insurers to cover a broader range of products for free under the Affordable Care Act — but only if they are prescribed. Insurers typically don’t cover OTC products.
A few states require state-regulated private health insurance plans to cover OTC contraception, but those rules don’t apply to most employer-sponsored plans.
Federal health officials are reviewing potential changes on how best to ensure coverage and access to OTC products, and a Department of Health and Human Services (HHS) request for public input at the end of September garnered nearly 400 responses.
But the agency hasn’t made any decisions yet, and there’s growing concern that without action, a patchwork of state policies could blunt the potential benefits of Opill.
“When Opill is on the market, it’s extremely important that everybody has access, that it’s sold at an affordable price and that people who do have insurance can use their insurance coverage to access it,” said Kelly Blanchard, president of Ibis Reproductive Health, which operates the Free the Pill campaign.
Affordability of birth control shouldn’t be dependent on a person’s zip code, Blanchard said, so the Biden administration needs to clarify that the Affordable Care Act also requires coverage for OTC products.
A push for federal action is also coming from Democratic governors.
California Gov. Gavin Newsom led a coalition of Democratic governors in December calling on HHS to expand private insurance coverage to OTC products and adopt a similar policy in federally funded health insurance plans such as Medicare and Medicaid.
“As allies in the fight for reproductive freedom, we urge you to take further steps to ensure that all women have access to necessary contraceptive services,” wrote the governors, who also included Pennsylvania Gov. Josh Shapiro, North Carolina Gov. Roy Cooper, New Mexico Gov. Michelle Lujan Grisham, Massachusetts Gov. Maura Healey and Illinois Gov. JB Pritzker.
“Without coverage that includes low or no out-of-pocket costs, over-the-counter birth control products become much less accessible,” they wrote.
In Congress, nearly all Senate Democrats have asked administration officials to take concrete steps to ensure contraceptives are covered without cost-sharing and without the need for a prescription.
But for advocates, the push to ensure Opill is affordable extends to the manufacturer, Perrigo Company, and retailers who will determine the price for people paying out of pocket. The manufacturer will set a list price, but individual retailers will decide what it will ultimately cost consumers.
Perrigo has yet to disclose what the retail price for the product will be, and a spokeswoman said only that “the company is committed to ensuring that Opill will be accessible to people who need it.”
Even a small cost burden can present a significant barrier and make a drug inaccessible.
For example, the Food and Drug Administration approved the first-ever OTC hearing aids in 2022, but the average cost was significantly higher than what people would have paid with insurance coverage.
A KFF survey from 2022 found nearly 40 percent of reproductive-aged women would be willing and able to pay between $1 and $10 per month, but only about 16 percent would be willing and able to pay more than $20 per month.
On Wednesday, the steering committee of the Free the Pill campaign called on Perrigo not to charge more than $15 for a three-month supply.
“Though we are also advocating for OTC birth control to be fully covered by insurance without a prescription or cost sharing, we know that because US health insurance is often tied to employment, a high retail price could also put Opill out of reach for people who don’t have employer-based insurance,” the group wrote in a letter to Perrigo’s leadership.
“A retail price of $15 for a three-month supply would help ensure that this groundbreaking product is affordable for those who face the most barriers to access, many of whom are also those with the least ability to pay.”