Catholic bishops to FDA: Don’t make ‘minipill’ contraceptive over-the-counter

Denver, Colo., May 16, 2023 / 14:10 pm

Federal regulators with the Food and Drug Administration should reject proposed over-the-counter use of the progestin-only “minipill” contraceptive, the U.S. bishops have said. They echo other critics who say the drug’s side effects mean patients should have physician supervision while taking the drug.

“It is concerning that the FDA has a recommendation before it to approve over-the-counter hormonal contraception when there is strong evidence of the many harmful risks to women’s health,” Bishop Robert E. Barron of Winona-Rochester, chairman of the U.S. Conference of Catholic Bishops’ (USCCB) Committee on Laity, Marriage, Family Life, and Youth, said May 15.

An advisory panel to the FDA on May 10 unanimously voted to recommend approval of the Opill birth control pill for over-the-counter availability. A final decision is expected this summer.

The progestin-only contraceptive, sometimes called the “minipill,” was proposed for over-the-counter use by its France-based manufacturer Laboratoire HRA Pharma.

“I urge the FDA to reject this recommendation,” Barron said.

“Fertility is a gift, not a disease,” Barron’s statement on behalf of the USCCB continued. 

“Contraceptives exist to suppress the healthy functions of human reproduction. The mounting evidence of the many harmful side effects of hormonal contraceptives demonstrates that they are not good medicine,” the statement said.

To allow hormonal contraception access without medical supervision, he said, is “antithetical to the Hippocratic Oath that guides physicians to first ‘do no harm.’” 

In Nov. 14, 2022, comments submitted to the FDA advisory panel, the USCCB joined the National Catholic Bioethics Center, the Catholic Medical Association, and the National Association of Catholic Nurses, who represent thousands of health care providers and medical ethicists, to oppose allowing over-the-counter use of Opill.

“The failure rate of the minipill is higher than that of other hormonal contraceptive methods and will result in many unintended pregnancies, leading to potentially more abortions,” the letter said. It warned of serious harm to teens who will have access to the drug without parental notification.

The letter cited the potential for negative side effects such as organ failure, cardiovascular disease, or neurological issues. The hormonal contraceptive may cause abnormal bleeding, ovarian cysts, and depression. Prescription use, the letter said, would allow the oversight from health care professionals that is necessary to monitor side effects.

Physicians and other health care professionals, the letter said, should monitor a patient’s use of the drug for side effects. Prospective patients should also be screened for known or suspected pregnancy, known or suspected breast cancer or other progestin-sensitive cancer, undiagnosed abnormal uterine bleeding, hypersensitivity to Opill components, acute liver disease, and benign or malignant liver tumors.

The USCCB cited the FDA’s May 2022 change to safety prescribing protocols because of evidence that hormonal contraception increases breast cancer risk. The change came in response to a Citizen’s Petition from the Contraceptive Study Group. The group of concerned health care professionals and educators submitted their analysis of hormonal contraceptives’ harmful side effects and asked the FDA to add a “black box” warning to the drug labeling requirements to inform the public of these risks.

According to the USCCB, the FDA offered “modest acknowledgment” of the risks of breast cancer and “quietly changed” safety protocols for prescribing hormonal contraception and the required information to be dispensed to patients with a prescription.

Progestogens, also known as progestins, are synthetic hormone drugs that mimic progesterone, a natural hormone vital for menstruation and pregnancy. Progestogen-only contraceptives are provided in various ways: as an implant, a hormonal intrauterine device, a contraceptive injection, or the “minipill.”

In March Oxford researchers published a study showing a 20% to 30% relative risk for breast cancer associated with progestogen-only contraceptives, compared with women who did not take oral contraceptives. The study drew on data from almost 10,000 U.K. women who were diagnosed with invasive breast cancer over a 21-year period and data from more than 18,000 women who were not diagnosed with breast cancer.

These contraceptives differ from the most popular contraceptive drug, a combined oral contraceptive pill that includes estrogen.

The World Health Organization’s International Association for Research of Cancer on its website lists estrogen-progestogen oral contraceptives as among 122 carcinogenic agents. It also notes “convincing evidence” that the drug has a “protective effect against cancer in the endometrium and ovary.”