The United States Food and Drug Administration (FDA) will be considering a bid from a foreign pharmaceutical company to permit the nonprescription, over-the-counter sale of a contraceptive pill.
The FDA public notice explained that “the committees will discuss supplemental new drug application … for OPILL (norgestrel) Tablet, 0.075 mg, submitted by Laboratoire HRA Pharma.”
“OPILL is proposed for nonprescription use as a once daily oral contraceptive to prevent pregnancy,” the notification continued.
The Opill from HRA Pharma originally earned approval from the FDA for prescription-only uses in 1973. HRA Pharma is a French subsidiary of the company Perrigo. Perrigo is an American company now headquartered in Ireland.
The application for over-the-counter use was first made in July 2022, at which time HRA Pharma representative Frédérique Welgryn said, “This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the U.S.”
“Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers,” he said.
Although the initial meeting to review the application was initially scheduled for November 2022, it was postponed by the FDA in October “in order to review additional information requested related to the Opill,” according to a company press release.
Perrigo recently announced, however, that the FDA had rescheduled the review for May 9 – 10.
Welgryn explained, “Women’s needs are nuanced, and it’s about time their health options reflect that.”
“At Perrigo, we’re not only committed to prioritizing women’s health — we’re committed to being active champions for it,” he continued.
Current FDA information notes that “Progestin-only oral contraceptives such as Opill Tablets prevent conception by suppressing ovulation in approximately half of the cycles in users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium.”
Side effects include ectopic pregnancies and ovarian cysts, with the FDA further identifying that “irregular menstrual patterns are common among women using Opill Tablets.”
Contraceptive use has remained controversial, however, and religious and anti-abortion groups suggest the pills are not acceptable.
Catholic Answers explained that “contraception is wrong because it’s a deliberate violation of the design God built into the human race, often referred to as ‘natural law.’”
Furthermore, the organization added that “recent studies reveal a far greater divorce rate in marriages in which contraception is regularly practiced than in those marriages where it is not. Experience, natural law, Scripture, Tradition, and the magisterium, all testify to the moral evil of contraception.”
In a similar vein, the activist group Students for Life drew a distinction between abortifacient and non-abortifacient drugs.
“Because our mission is to abolish abortion, Students for Life of America does not take a stance on the morality of non-abortifacient contraceptives. But we are formally opposed to abortifacient varieties,” the group explained.
They also suggest that “birth control hasn’t lowered the abortion rate” and that it “disrespects women,” pointing out that some contraceptives have significant side effects.
The Dallas Express reached out to Students for Life for additional comment on the issue but did not hear back prior to publication. Live Action and Avow Texas were also contacted for comment.