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.