The FDA has approved the first birth control pill to be sold over the counter without a prescription in the U.S.
The U.S. Food and Drug Administration approval of oral contraception drug Opill came Thursday, National Review reports.
Opill, manufactured by drugmaker Perrigo, is considered a “mini pill,” part of an older class of contraceptive containing progestin only. Most chemical contraception pills used in the U.S. are known as “combination” pills and have both progestin and estrogen.
The chemical contraception pill's over-the-counter approval comes following a panel of 17 independent health advisers to the FDA voted unanimously in May in favor of approving the drug's over-the-counter use, stating that the benefits outweighed the risks.
The panel’s vote came despite numerous concerns raised by FDA scientists over how Perrigo had studied its drug. These concerns include questions over whether study participants were able to understand and follow labeling instructions.
The FDA had found that more than 30% of study participants erroneously reported taking more pills than they were given, prompting questions about Perrigo’s conclusions about its drug’s use and effectiveness.
Additionally, FDA regulators had indicated that changes in U.S. demographics since Opill was first tested — including increased obesity and other chronic conditions— could decrease the drug’s effectiveness. Opill had first gained approval in the U.S. in 1973 based on data saying it was more than 90% effective in preventing pregnancy when taken daily. It has not been marketed in the U.S. since 2005.
The FDA's concerns over approval of Opill for over-the-counter use also included situations with women having certain medical conditions that should preclude them from taking birth control pills, including breast cancer and undiagnosed vaginal bleeding, and whether these women would heed the product warning not to take it. The advisory panel members dismissed the concerns, saying that women with breast cancer would have doctors who would warn them to avoid the pill. The panel said as well that it is important for adolescents to have access to an over-the-counter form of birth control that is more effective than condoms and other methods of contraception currently available over the counter.
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Heartbeat International, the largest network of pregnancy help organizations - pregnancy centers and medical clinics, non-profit adoption agencies, and maternity homes - in the U.S. and the world, in conjunction with the Leadership Alliance of Pregnancy Care Organizations (LAPCO), upholds the national standard of ethical practices with the tenet that pregnancy help organizations do not offer, recommend or refer for abortions, abortifacients or contraceptives, as well as a commitment to offering accurate information about related risks and procedures. This standard links and rejects abortions, abortifacients, and contraceptives as appropriate services of pregnancy help organizations because of the sanctity of every human life - which begins at the moment of conception.
From Heartbeat's FAQs on the provision of contraceptives by pregnancy help organizations:
By putting a woman on the pill or providing contraceptives, we are likely, in fact, to be exposing her to a future abortion, since we know that more than half (51%) of abortion patients in the United States reported that they had used a contraceptive method in the month they became pregnant.
Many researchers conclude that the pill often acts as an abortifacient. “Breakthrough” ovulation can occur when a woman is on the pill, she may conceive, but the pill has thinned the lining of the uterus so that the tiny embryo cannot implant and so is aborted (clearly, the pill does not always contra-cept). So-called contraceptives such as the “the morning after pill” Plan B can also act as abortifacients depending on when they are taken during a woman’s cycle, and the Ella brand does act as an abortifacient.
Since the pill has a large failure rate – the CDC reports 7-13% – those on the pill will be encouraged by medical providers to switch to implants that have additional health risks, and even to IUDs which act as abortifacients.
With the pill’s high failure rate, it often leads to an abortion. The choice to use contraception is to prevent what the woman sees as the worst possible outcome of her sexual behavior – a pregnancy and a baby. Therefore, they may rationalize that they were being “responsible” by using the pill, and, since it failed, abortion is now the responsible choice to make.
More information on the FAQs is available HERE.
Opill manufacturer Perrigo, based in Dublin, Ireland, said that Opill will like become available in the U.S. beginning in early 2024, according to the National Review report. How much the pill will cost is not known, though Perrigo Global Vice President for Women’s Health Frédérique Welgryn said in a statement that Perrigo was committed to making the drug “accessible and affordable to women and people of all ages.”
While the FDA’s approval of Opill for over-the-counter use does not apply to other chemical contraception pills, advocates of its over-the-counter approval have hoped that an approval might prompt other drugmakers to seek over-the-counter approval for their contraception drugs.
Cadence Health, which makes a combination pill, has been in talks with the FDA as well about applying for its drug to be sold over the counter, the National Review report said.
The Obamacare contraception mandate does encompass prescription chemical contraception but not over-the-counter contraception. Last month President Joe Biden released an executive order directing the secretaries of the Treasury Department, Labor Department, and Health and Human Services to “consider new actions to improve access to affordable over-the-counter contraception.”
