Hirono, Murray, Cortez Masto Lead Colleagues In Urging Opill Manufacturer to Release An Affordable Retail Price and Broad Distribution Strategy

WASHINGTON, D.C. – Today, U.S. Senators Mazie K. Hirono (D-HI), Patty Murray (D-WA), and Catherine Cortez Masto (D-NV) led seven of their Senate colleagues in urging Perrigo, the manufacturer of Opill, to follow through on its commitment to make the contraceptive “affordable and accessible” by releasing a low and affordable retail price and beginning broad distribution of the product as soon as possible. Earlier this month, the U.S. Food and Drug Administration (FDA) approved Opill—a daily hormonal contraceptive pill—for over-the-counter sale without a prescription, making it the first OTC birth control pill available without a prescription in the United States.

“The FDA’s evidence-based approval of Opill for over-the-counter use removed an unnecessary barrier to accessing basic health care and is a critical step forward in the fight for equitable reproductive health care,” wrote the lawmakers. “Contraception is a key component of reproductive health and enables people to control their futures by deciding if, when, and how to become pregnant.”

In the letter, the lawmakers emphasized the importance of equitable access to contraception and highlighted the barriers—such as prohibitive costs, lack of insurance coverage, difficulty accessing transportation, and more—that people face in obtaining and refilling prescriptions for birth control. Recent polling showed that of those interested in using OTC birth control, nearly 85 percent would be unwilling or unable to pay more than $20 per month for it. They also underlined how these barriers disproportionately impact marginalized communities, including people of color, LGBTQ+ individuals, immigrants, people with disabilities, and people living in rural communities.

“The FDA’s decision to make Opill available without a prescription has the potential to transform contraceptive access nationwide, especially for the 19 million women living in contraceptive deserts and the 4.9 million women who are uninsured,” continued the lawmakers. “When it comes on the market, Opill will be the most effective contraceptive product available over-the-counter and will be a major step forward for contraceptive access by eliminating many of the obstacles inherent in obtaining contraception via prescription.”

Specifically, the letter requests that Perrigo answer the following questions:

1. Will Perrigo sell Opill at a low and affordable cost? What criteria will be used to determine Opill’s price?
2. Where, specifically, does Perrigo plan to sell Opill? What factors will Perrigo consider in building those retail relationships, and with whom will Perrigo consult to ensure its products will reach underserved populations?
3. Who will be eligible for the “consumer assistance programs” and for how long can participants expect financial support? What discounts or rebates will Perrigo offer, particularly for individuals without insurance or limited income?
4. How will Perrigo make its product accessible to individuals who may want their purchase to be confidential?

In addition to Senators Hirono, Murray, and Cortez Masto, the letter was also signed by Senators Tammy Baldwin (D-WI), Richard Blumenthal (D-CT), Sherrod Brown (D-OH), Tina Smith (D-MN), Elizabeth Warren (D-MA), Peter Welch (D-VT), and Jeff Merkley (D-OR).

The letter is also endorsed by Contraceptive Access Initiative (CAI); Planned Parenthood Federation of America; National Partnership for Women and Families (NPWF); NARAL Pro-Choice America; National Family Planning & Reproductive Health Association (NFPRHA); Power to Decide (PTD); Center for American Progress (CAP); Ibis Reproductive Health.

A long-time champion for abortion access, Senator Hirono is committed to protecting the fundamental right to reproductive care for all. Earlier this year, she reintroduced the Affordability is Access Act to help ensure that once the FDA approves an over-the-counter birth control option, insurers must fully cover over-the-counter birth control without any out-of-pocket costs. Last summer, Senator Hirono also introduced the Right to Contraception Act, as well as the Expanding Access to Family Planning Act, to protect access to critical reproductive health care services, like birth control, and cancer screenings.

The full text of the letter is available here and below.

To Mr. Lockwood-Taylor:

We are writing in recognition of the U.S. Food and Drug Administration’s (FDA) approval of Opill, the first over-the-counter (OTC) birth control pill in the United States. The FDA’s evidence-based approval of Opill for over-the-counter use removed an unnecessary barrier to accessing basic health care and is a critical step forward in the fight for equitable reproductive health care. We appreciate Perrigo’s leadership in this historic moment to make safe and effective oral contraception available to people of all ages without a prescription. However, to realize equitable access to birth control, Opill must be affordable. With this in mind, we urge you to release an affordable retail price for Opill and to begin broad distribution of the product as soon as possible.

Contraception is a key component of reproductive health and enables people to control their futures by deciding if, when, and how to become pregnant. Every person has the fundamental right to make decisions about their own bodies, including the right to contraception—however, many people face real barriers to obtaining and refilling prescriptions for birth control. Such barriers include: prohibitive costs, lack of insurance coverage, appointment wait times, and difficulty accessing childcare, time off from work, or transportation. Furthermore, these barriers to contraception—and to health care generally—disproportionately affect people of color, LGBTQ+ individuals, immigrants, people living in rural communities, people with disabilities, young people, and those without insurance. The FDA’s decision to make Opill available without a prescription has the potential to transform contraceptive access nationwide, especially for the 19 million women living in contraceptive deserts and the 4.9 million women who are uninsured. When it comes on the market, Opill will be the most effective contraceptive product available over-the-counter and will be a major step forward for contraceptive access by eliminating many of the obstacles inherent in obtaining contraception via prescription.

Interest in Opill is high: in 2022, two in five women of reproductive age said they would be likely to use an OTC birth control pill. However, of those likely to use an OTC birth control pill, nearly 85 percent said they would be unwilling or unable to pay more than $20 per month for it. When contraception is not affordable, some people—primarily uninsured individuals—end up forgoing contraceptives altogether. Therefore, it is critical that the out-of-pocket price for Opill for individuals without health insurance is affordable, and that individuals who are insured have Opill fully covered under their health insurance, with no copays or out-of-pocket costs. Given the full-blown reproductive health care crisis caused by the Supreme Court overturning Roe v. Wade and the right to abortion in the U.S., Opill’s retail price should be even more affordable than comparable progestin-only over-the-counter birth control pills in countries like the UK, where a month’s supply is approximately $13.

Opill will be particularly important for people living in rural communities for whom getting a prescription for contraception is especially difficult due to provider shortages, distance from providers, and long wait times. While over-the-counter contraception can help bypass some of these barriers, there are often fewer pharmacy retailers in rural communities—we believe Perrigo should work to make sure Opill is stocked in rural areas so that access to over-the-counter contraception is not dependent on a person’s zip code.

Additionally, Opill must be available equitably in various retailers across the United States, including pharmacies, convenience stores, grocery stores, and online. We also encourage you to work with retailers to ensure Opill is not kept behind the pharmacy counter or locked behind plexiglass doors or within clamshell containers. The cost and availability of your product will directly impact people’s reproductive health, wellbeing, and opportunities.

To better understand how Perrigo can make Opill “accessible and affordable to people of all ages”, we ask for your response to the following questions at your earliest opportunity:

1. Given that the vast majority of women interested in OTC contraception would be unable or unwilling to pay more than $20 per month, will Perrigo sell Opill at a low and affordable cost? What criteria will be used to determine Opill’s price?

2. Where, specifically, does Perrigo plan to sell Opill? What factors will Perrigo consider in building those retail relationships, and with whom will Perrigo consult to ensure its products will reach underserved populations?

3. Who will be eligible for the “consumer assistance programs” you have discussed, and for how long can participants expect financial support? What discounts or rebates will Perrigo offer, particularly for individuals without insurance or limited income?

4. How will Perrigo make its product accessible to individuals who may want their purchase to be confidential?

Congratulations on securing FDA approval for the nonprescription daily use of Opill. While our work to expand access to over-the-counter contraception and ensure accessibility of Opill is not finished, we appreciate your leadership in advancing reproductive health access. We look forward to hearing from you.

Sincerely,

###