The Food and Drug Administration (FDA) on Thursday approved Opill, a progestin-only birth control pill (POP), for over-the-counter (OTC) use.
This is the first time that a birth control pill has been approved for OTC use in the United States.
Opill is a safe and effective form of birth control that has been on the market for over 40 years. It is a low-dose pill that is taken once a day. Opill is effective in preventing pregnancy when taken correctly.
The approval of Opill as an OTC drug is a major victory for reproductive health advocates. It will make birth control more accessible to women and girls, especially those who face barriers to healthcare.
For example, Opill will be available without a prescription, which means that women will no longer have to go to the doctor to get it. This will make it easier for women to get the birth control they need, when they need it.
The approval of Opill is also a significant step forward in the fight for reproductive justice. In recent years, there have been a number of attacks on reproductive rights in the United States. The approval of Opill is a reminder that access to birth control is essential to women’s health and well-being.
‘Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,’ stated Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
The accessibility of contraception has become an increasingly urgent issue, particularly since the Supreme Court overturned the constitutional right to abortion in its June 2022 Dobbs decision.
While the cost of the pill has not been disclosed, its eventual price tag will play a crucial role in determining how many people will be able to use it.
Frédérique Welgryn, the global vice president for women’s health of Opill manufacturer Perigo, said that the company is committed to ensuring accessibility and affordability for individuals of all ages.
Perrigo plans to implement a consumer assistance program to provide the pill at no cost to certain individuals, according to The New York Times.
“If available equitably — meaning that they are priced affordably and fully covered by insurance — over-the-counter birth control pills will be a game-changer for communities impacted by systemic health inequities,” said Dr. Daniel Grossman, an over-the-counter contraception researcher.
Perrigo said the medication will likely be available from both physical stores and online retailers in the U.S. starting in early 2024.
“Over-the-counter birth control pills will help bridge gaps in access and give people greater control over their reproductive health and lives,” said Victoria Nichols, project director of Free the Pill. “FDA approval is an important step forward, but we must ensure that OTC birth control pills are equitably accessible to all. To ensure equitable access we must continue to advocate for OTC birth control pills to be affordably priced and fully covered by insurance.”
The FDA’s approval of Opill is a historic moment. It is a victory for reproductive health advocates and a step forward in the fight for reproductive justice. Opill will make birth control more accessible to women and girls, and it will help to ensure that all women have the right to make their own decisions about their bodies.
“Birth control is an urgent health care need now more than ever,” said Lisa McCormick, a New Jersey women’s rights advocate. “Contraception is one of the best ways to prevent unwanted pregnancies, which is critical now that right-wing extremists are making it difficult to obtain a safe, legal abortion.”
“Today’s FDA decision is a critical victory for reproductive health and freedom,” said McCormick. “The overturning of Roe v. Wade has unleashed immense harm and suffering across the nation in the past year.”
“The approval of Opill is a major step forward, but there is still more work to be done to ensure that birth control is affordable and covered by insurance,” said McCormick. “We must to continue to fight for reproductive justice and ensure that all women have access to the birth control they need.”
“I have urged the FDA to make the abortion pills mifepristone and misoprostol over the counter, but this is an important part of expanding access to freedom of choice because preventing unwanted pregnancy is better than forcing Americans to give birth or endure an abortion,” said McCormick.
“We’re thrilled by the FDA’s historic decision to approve Opill as the first-ever over-the-counter birth control pill,” said Lupe M. Rodríguez, executive director of the National Latina Institute for Reproductive Justice. “At the Latina Institute, we believe that everyone should have access to the full range of sexual and reproductive healthcare, including birth control.”
“I’m thrilled the FDA followed the science and the unanimous decision of its advisory committee and has authorized Opill for sale over the counter. Having an OTC option for birth control pills is incredibly important and long overdue,” said Debra Hauser, president of Advocates for Youth.
Opill is expected to be available over the counter in stores starting in January or February 2023. It will not have an age restriction. The suggested retail price is expected to be announced this fall.