Bishop Robert Barron has expressed concern over the recent approval granted by the U.S. Food and Drug Administration (FDA) for the first over-the-counter birth control pill, known as Opill.

“This action by a government entity flies in the face of responsible medical practice and concerns for women’s health,” Barron said in a release put out by the U.S. Conference of Catholic Bishops (USCCB). “Claims that the benefits of this action outweigh the risks are unfounded, especially in light of strong evidence of the many harmful risks of hormonal contraception to women’s health.”

Barron chairs the USCCB’s Committee for Laity, Marriage, Family Life, and Youth, and is the Bishop of the Diocese of Winona-Rochester, Minnesota.

“Allowing this hormonal contraception to be dispensed ‘over the counter’—without the supervision of a doctor and contrary to the mounting evidence of many harmful side effects—violates the Hippocratic Oath by putting the health of women at grave risk," Barron said in the statement.

The FDA granted approval for the sale of birth control pills without a prescription in May. Advisory panels this month agreed, with a unanimous 17-0 vote, to make Opill available over the counter. With that final approval, Opill becomes the first birth control pill to be able to be bought without a prescription in the United States, NBC News said in a report.

The availability of the birth control pill to be purchased over the counter without medical supervision has raised concerns regarding safety and effectiveness. For birth control pills to have maximum efficacy, they must be taken daily, and some wonder whether those who aren’t under a doctor’s care will take it every day. The pill also has some potential side effects. Some of those include a higher risk of breast cancer, vaginal bleeding and neurological conditions. Despite those reservations, the pill is already available without a prescription in more than 100 countries worldwide, NBC News added.

“Fertility is a gift, not a disease," Barron said in May, when the FDA first voted in favor of over-the-counter contraceptives. "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.”