FDA Acknowledges Harm of Oral Contraceptives While Its Own Panel of Advisors Push to Make Drug Available Without Prescription
WASHINGTON - On Wednesday, May 10, a panel of advisors to the U.S. Food and Drug Administration (FDA) voted unanimously to make the birth-control drug, Opill, available to consumers over-the-counter in the United States. The FDA is reportedly poised to make a final decision this summer. In response to the FDA panel’s recommendation, Bishop Robert E. Barron of Winona-Rochester, and chairman of the U.S. Conference of Catholic Bishops’ (USCCB) Committee on Laity, Marriage, Family Life and Youth, urged the government agency to reject this advice as “not good medicine” and continue their efforts to protect women’s health.
“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. In fact, in May 2022, the FDA changed their safety prescribing protocols because of a Citizens’ Petition from healthcare professionals and educators that raised scientific evidence of the increased risk of breast cancer with the use of hormonal contraception.
“Fertility is a gift, not a disease. 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. And yet, now the FDA is faced with the decision on whether to allow access to hormonal contraception without medical supervision. Allowing this to go forward is antithetical to the Hippocratic Oath that guides physicians to first ‘do no harm,’ and I urge the FDA reject this recommendation.”
In May 2022, the FDA acknowledged the risks of breast cancer with hormonal contraceptive use by changing its safety prescribing protocols in partial response to a Citizens’ Petition submitted by a group of concerned healthcare professionals and educators that formed the Contraceptive Study Group (CSG). The Citizens’ Petition analyzed research about the risks of hormonal contraceptives demonstrating numerous harmful side effects and the CSG requested the FDA to inform the public of those risks through reasonable labeling (“black box” warnings).
The FDA posted a partial reply offering modest acknowledgment of the risks of breast cancer with hormonal contraceptive use, and quietly changed the safety protocols for prescribing, as well as information that should be in the inserts when the prescription is dispensed to patients.
Last November, the USCCB joined with the National Catholic Bioethics Center (NCBC), Catholic Medical Association (CMA), and the National Association of Catholic Nurses (NACN) to oppose the non-prescription availability of Opill without the supervision of a healthcare professional, citing the potential for numerous negative side effects including organ failure, cardiovascular disease, or neurological issues among others.