FDA prioritizes profits over women’s health by approving over-the-counter birth control.
The First Over-the-Counter Hormonal Contraceptive Approved by FDA
The U.S. Food and Drug Administration (FDA) recently made a groundbreaking decision by approving the first over-the-counter hormonal contraceptive on the market. Opill, a single synthetic hormone pill manufactured by Perrigo Co., will soon be available for purchase at various locations including pharmacies, convenience stores, grocery stores, and online.
While the FDA states that Opill is not intended for use as emergency contraception, it’s important to note that the pill’s single synthetic hormone, progestin, has two modes of action. It not only thickens cervical mucus to decrease the chances of sperm reaching the egg but can also thin the uterine lining, potentially preventing implantation of a fertilized egg.
The Concerns of Medical Professionals
The Catholic Medical Association, a group of 2,600 healthcare professionals, expressed deep concern about the FDA’s decision. Kathleen Raviele, M.D., OBGYN on CMA’s Board of Directors, emphasized the importance of -counter birth control.”>women receiving authentic medical care and being seen by a physician to ensure the safety of a potent drug like a birth control pill.
Ignoring Over-the-Counter Requirements
Jane Orient, the executive director of the Association of American Physicians and Surgeons, criticized the lack of standard safety procedures in making Opill available without a prescription. She highlighted the significant risk of serious side effects associated with oral contraceptives and emphasized the need for medical supervision.
The Risks and Complications
The Catholic Medical Association listed numerous side effects of Opill, including increased risk for breast lumps, ovarian cysts, depression, and other issues. It is also crucial to take the pill at the same exact time each day for it to be effective. The FDA’s decisional memo acknowledged the need for data-driven evidence of safe and effective use without physician oversight, but certain limitations were identified in the data.
Despite these concerns, top doctors at the FDA determined that the potential benefits of Opill, such as preventing unwanted pregnancies, outweigh the risks.
A Failure for Women’s Health
Opill has been available by prescription since 1973 but has not been a preferred choice for OB-GYNs due to its side effects. Extensive medical studies have confirmed the risks and negative health implications of hormonal contraceptives, including their classification as Class 1 carcinogens and their links to cancer. Additionally, they have been found to triple the risk of suicide.
Supporters of hormonal contraceptives applaud the availability of an over-the-counter option. However, critics like Michelle Cretella, M.D., warn that easy access to these contraceptives may lead to increased sexual experimentation among young individuals and provide tools for sexual predators.
Funding Conflict of Interest
Some argue that the FDA’s focus on initiatives like over-the-counter birth control and “rumor control” diverts attention from the issue of contaminated medications entering the U.S. from overseas. The FDA’s funding from pharmaceuticals has raised concerns about potential conflicts of interest.
While recalling over-the-counter drugs is challenging, it remains to be seen whether Opill will gain popularity in the coming years.
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