FDA approves first nonprescription oral contraceptive ‘Opill’ 

Washington, D.C. Newsroom, Jul 13, 2023 / 14:00 pm

The U.S. Food and Drug Administration (FDA) on Thursday announced the approval of the first nonprescription oral contraceptive, called “Opill.” The drug’s approval is likely to lead to increased use of contraception, a practice that is directly contradictory to Catholic moral teaching.

Though more than 100 countries have approved over-the-counter birth control, according to the Free the Pill Coalition, Opill is the first oral contraceptive to receive FDA approval for use in the U.S. without a prescription. This means that Opill will be available to all ages, available at retail drug stores, without the consultation or guidance of a doctor. 

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.” 

Opill is a single pill used daily to prevent pregnancy. It is produced by Perrigo, an American Irish-registered pharmaceutical company headquartered in Dublin. 

According to Perrigo, Opill is a progestin-only contraceptive that is safe for all ages, so long as menstruation has begun. Progestin is a synthetic drug that mimics progesterone, the hormone that normally works after conception to thicken the uterine lining to create a good environment for a fertilized egg to implant. 

Opill differs from other commonly used two-step oral contraceptives, which contain an estrogen pill. 

Perrigo claims that the pill is 98% effective at preventing pregnancy. It works by thickening cervical mucus, which helps to both block the implantation of sperm as well as sometimes blocking the ovaries from releasing eggs.

Perrigo Global Vice President for Women’s Health Frederique Welgryn called the FDA’s Opill approval “a giant leap for women’s empowerment.”

According to FDA Center for Drug Evaluation and Research Director Patrizia Cavazzoni, “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.”

Yet, 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.” 

Additionally, though the FDA has now approved Opill, the Associated Press reported in May that the administration had concerns about the reliability of some of Perrigo’s data on the drug. AP also reported that the FDA “questioned whether women with certain other medical conditions would correctly opt out of taking it” and “also noted signs that study participants had trouble understanding the labeling instructions.”

The FDA approved Opill in July nonetheless. Perrigo says that the drug will be available in stores across the U.S. and online “early in the first quarter of 2024.” 

This comes as the pending FDA v. AHM lawsuit concerning a different pill called “mifepristone,” which is used as an abortifacient, continues to work its way through the courts. 

In this case, the Alliance for Hippocratic Medicine and several other pro-life organizations being represented by the Alliance Defending Freedom are suing the FDA for its mifepristone approval. 

According to the Alliance Defending Freedom, the FDA failed to protect the health and safety of women and girls by “illegally approving chemical abortion drugs” after having “never studied the safety of the drugs under the labeled conditions of use” and overlooking “the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls.” 

On April 7 U.S. District Court Judge Matthew Kacsmaryk overturned the FDA’s mifepristone approval, effectively banning its use in the U.S. However, the Biden administration’s request for the ruling to be temporarily blocked pending their appeals was granted by the U.S. Supreme Court. For now, mifepristone remains legal while the case is argued in the Fifth Circuit Court of Appeals. 

Contraceptive pills advocacy group Free the Pill Coalition applauded the FDA’s approval of Opill in a Thursday press release, calling it a cause for celebration, “especially in light of the ongoing attacks on reproductive health and rights.”

“We will continue our critical work to advocate at the federal and state levels to expand insurance coverage of OTC [over the counter] birth control pills and ensure everyone who wants to can walk into their local pharmacy and pick up a pack of birth control pills right off the shelf,” Free the Pill said in its press release.