The Food and Drug Administration on Thursday approved a birth control pill to be sold without a prescription for the first time in the United States, a milestone that could significantly expand access to contraception.
The medication, called Opill, will become the most effective birth control method available over the counter — more effective at preventing pregnancy than condoms, spermicides and other nonprescription methods. Experts in reproductive health said its availability could be especially useful for young women, teenagers and those who have difficulty dealing with the time, costs or logistical hurdles involved in visiting a doctor to obtain a prescription.
The pill’s manufacturer, Perrigo Company, based in Dublin, said Opill would most likely become available from stores and online retailers in the United States in early 2024.
The company did not say how much the medication would cost — a key question that will help determine how many people will use the pill — but Frédérique Welgryn, Perrigo’s global vice president for women’s health, said in a statement that the company was committed to making the pill “accessible and affordable to women and people of all ages.” Ms. Welgryn has also said the company would have a consumer assistance program to provide the pill at no cost to some women.
“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,” Dr. Patrizia Cavazzoni, director of the F.D.A.’s Center for Drug Evaluation and Research, said in a statement. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”
Since the Supreme Court overturned the national right to an abortion last year, the accessibility of contraception has become an increasingly urgent issue. But long before that, the move to make a nonprescription pill available for all ages had received widespread support from specialists in reproductive and adolescent health and groups like the American Medical Association, the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians.
CNA adds this important context:
Paragraph 2370 of the Catechism of the Catholic Church unequivocally condemns the use of contraceptives to prevent pregnancy as a grave moral evil. According to Church teaching, “every action which, whether in anticipation of the conjugal act, or in its accomplishment, or in the development of its natural consequences, proposes, whether as an end or as a means, to render procreation impossible” is “intrinsically evil…”
… Dr. Ingrid Skop, an OB-GYN and director of medical affairs at the Charlotte Lozier Institute, told CNA that “there are several concerns with this progesterone-only formulation.”
Skop explained that though the FDA likely approved Opill because it does not contain estrogen, presenting a lower risk of clotting disorders, hypertension, and diabetes, “missing in the conversation is the fact that it is not as effective.”
“Distributing this without a physician’s visit will prevent women from obtaining more effective contraception, giving a false sense of security and increasing unintended pregnancies,” Skop said.
Skop added that “because it does not prevent ovulation as well as other methods, there is also a concern of a post-fertilization (abortifacient) effect on the uterine lining.”