HRA Pharma expects a final decision from the FDA this summer on its over-the-counter application for Opill, which is generically called norgestrel.
The Food and Drug Administration on Thursday approved the first over-the-counter birth control pill, a landmark decision that will enable more women and girls in the US to prevent unintended pregnancies no prescription.
The daily pill, called Opill, was the first approved by the FDA as a prescription in 1973.
The pill’s maker, Paris-based HRA Pharma, said the contraceptive would most likely be available in pharmacies, convenience stores, supermarkets and online retailers in the US by early 2024.
HRA Pharma, a unit of the Dublin-based pharmaceutical company perrigoHe said there will be no age restrictions for the sale of the pill.
HRA Pharma has not announced the price of the pill, which will determine how affordable it will be for the public. But the company is committed to making the pill “accessible and affordable for women and people of all ages,” Frederique Welgryn, Perrigo’s global vice president of women’s health, said in a statement.
Perrigo’s share price rose 5% in early trading on Thursday following the announcement.
Opill could significantly expand access to contraception, especially for younger women and those in rural and underserved communities who often have trouble getting their birth control.
The approval of the pill is a victory for the Biden administration, which has sought to shore up reproductive rights as abortion restrictions increase in many states.
The Supreme Court’s decision to overturn the landmark Roe v. Wade more than a year ago, which ended 50 years of federal abortion rights, has led to reduced availability of the procedure across the country and renewed calls to expand access to birth control.
“Today’s approval is a groundbreaking expansion for women’s health in the US and an important milestone in addressing a key unmet need for access to contraceptives,” Welgryn said in the statement.
Oral contraceptives have long been the most common form of birth control in the US, used by tens of millions of women since the 1960s. But until now, they all required a prescription.
Medical organizations like the American College of Obstetricians and Gynecologists and women’s health advocates have pushed for broader access.
More than 50 members of Congress in March 2022, he also called on FDA Commissioner Dr. Robert Califf to ensure that the agency reviews applications for over-the-counter birth control pills without delay.
Those groups have noted that about 45% of the 6 million annual pregnancies in the US are unintended.
Unintended pregnancies have been linked to negative outcomes, including a reduced likelihood of receiving early prenatal care and an increased risk of preterm birth, according to the FDA. Those complications are also associated with adverse child development and health outcomes, the agency said.
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement that daily oral contraceptives are safe and “expected to be more effective than those currently available.”
non-prescription contraceptive methods to prevent unwanted pregnancies.
Other non-prescription methods include condoms and spermicide.
Opill was found to be 93% effective in preventing pregnancy, similar to prescription oral contraceptives.
The pill contains a hormone called progestin, which prevents pregnancy by thickening the cervical mucus to prevent sperm from reaching and fertilizing an egg.
FDA scientists expressed concern in May about whether women who have or have had breast cancer would know not to use the drug. The hormone progestin can increase the risk of breast cancer coming back.
The agency’s scientists were also concerned that some women with unexplained vaginal bleeding between menstrual cycles would know not to take Opill before consulting a doctor first.
But ultimately, an FDA advisory panel agreed that most women could determine for themselves whether the drug was suitable for their use.
That panel also voted unanimously to recommend making Opill available without a prescription.