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Catholic Medical Association Deeply Concerned About FDA’s Approval of First OTC Oral Contraceptive

July 13, 2023

Philadelphia, Pa. – July 13, 2023 – The Catholic Medical Association (CMA) expresses deep concern regarding the decision by the Food and Drug Administration (FDA) to approve the first over the counter (OTC) hormonal contraceptive, Opill.

“Given the extensive medical studies demonstrating the risks and adverse effects of hormonal contraceptives, CMA is disappointed and concerned for the health and safety of women across the United States with this initial approval,” said Craig Treptow, M.D., President of CMA.

Supporters are already talking about this decision paving the way for additional contraceptives more potent than the ‘minipill’ and even the abortion pill to become available over the counter. And this approval comes despite some concerns by FDA scientists about the manufacturer Perrigo’s results, including whether women with certain underlying medical conditions would understand they should not take the drug like those who have or have had breast cancer, certain liver diseases, unexplained uterine bleeding or take certain medicines for tuberculosis, HIV/AIDS or to control seizures.

“This shows a total lack of regard for a woman’s health to offer a hormonal contraceptive available over the counter, without medical supervision. Women should be seen by a physician to make sure a drug as potent as a birth control pill is safe for her to take. These women deserve authentic medical care,” said Kathleen Raviele, M.D., an OBGYN and member of CMA’s Board of Directors.

Over the past twenty years, a range of medical publications such as The Lancet and The American Journal of Psychiatry have reported increased risk of a wide variety of problems, including breast cancer, brain tumor, HIV transmission, and suicide, none of which are lessened with Opill even if it is a single synthetic hormone.

“More troubling are statements by the World Health Organization that classifies oral contraceptives as a Class 1 carcinogen. Even the National Cancer Institute reports increased risk of breast and cervical cancer with these drugs,” said Tim Millea, M.D., Chair of CMA’s Health Care Policy Committee.

“The social impact of this decision is dramatic. More women, particularly adolescents and young adults, will develop these adverse effects. In addition, as they will no longer need medical evaluation to receive contraceptives, the delayed and missed diagnosis of cancer and sexually transmitted infections will become common. Sex traffickers will be free to purchase OTC contraceptives for the women under their control. This is not a victory for women’s health,” added Dr. Millea.