Opill Threatens to Slip into Vulnerable Hands
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The US Food and Drug Administration (FDA) plans to discuss the application submitted by French pharmaceutical company HRA Pharma for a new nonprescription drug called Opill in a public meeting soon. Opill is an oral progestin-only contraceptive. According to a public comment submitted to the FDA on November 14 and cosigned by The National Catholic Bioethics Center (NCBC), nonprescription contraceptives place women at disproportionate risk of adverse side effects. Moreover, this risk would affect especially adolescent women, who are recognized as a vulnerable population.
Opill belongs to a category of contraceptives commonly called POPs or the minipill. Opill has to be taken every day, at the same time each day, in order to achieve maximum effectiveness. According to the US Centers for Disease Control and Prevention, Opill prevents pregnancy by suppressing ovulation during about half of a woman’s menstrual cycle, thickening her cervical mucus to inhibit sperm penetration, lowering her mid-cycle LH (luteinizing hormone) and FSH (follicle-stimulating hormone) peaks, slowing the ovum’s movement through the fallopian tubes, and thinning the interior lining of her uterus. In these ways, Opill is no different than numerous other progestin-only contraceptive pills like Errin or Norethindrone.
However, in the letter cosigned by the NCBC, the glaring differences between Opill and most other progestin-only contraceptives become quite clear—the most significant of these differences being that Opill is not a prescription drug. Though Americans have been pushing for over-the-counter birth control since 1968, obstetricians and gynecologists remained staunchly opposed until more recently. According to the NCBC et al., nonprescription contraceptives “violate [the] inviolable standard of care” to “do no harm.” The NCBC joined obstetrician-gynecologists across the country in advising that contraceptives have “documented and potentially life-threatening side effects,” and women “should be medically evaluated for contraindications to the drug” before taking it.
Over-the-counter contraceptives could cause additional harm like increasing the incidence of unplanned pregnancies. Research in this area often focuses on women who are not using contraception, but according to a 2007 study funded by the National Institutes of Health and conducted by the Guttmacher Institute, approximately 24 percent of all pregnancies in the United States are unintended ones that occur among women using contraception. This statistic reflects the situation of women whose doctors have listened to their medical histories, habits, and lifestyle choices and have explained to them the dosing schedule, side effects, and risks of the drug they prescribe with the authority of a professional. One can only imagine how high that statistic would be should women be able to walk into a Walgreens alone, pick out their own birth control without any sort of medical guidance, and administer it to themselves without consultation.
Perhaps the most interesting consideration in the letter is the demographic of individuals who would likely be purchasing Opill over the counter. It claims that Opill would likely cause disproportionate risk to teenagers in the United States. The argument to this effect is twofold. First, one major side effect of Opill is depression, which teenagers have increasingly suffered from since the 2020 pandemic. Second, teenagers are more likely to “take risks disproportionate to their own safety needs” than are other demographics. While both parts of the argument merit consideration, I would like to focus especially on the second part.
Even if a teenager who uses Opill were to read the ingredients, dosing instructions, warnings, risks, and all other pertinent information about the drug before taking it, and then determine that Opill was safe for her to take, there remains the fact that contraceptives rely on an extremely strict dosing schedule for their effectiveness, which teenagers are more likely than others to violate. Teenagers have a more limited perspective and are less responsible than adults. Thus, they are more likely to forget or willfully disregard important guidelines designed to ensure the potency of Opill and—once again, as the letter states— to “take risks disproportionate to their own safety needs.”
These guidelines include but are not limited to the following: ensuring that an alternative method of contraception (e.g., condom, spermicide) is used during sex for the first forty-eight hours after starting Opill, missing a dose, or even not taking a dose within just three hours of the usual time of ingestion. Additionally, the guidelines direct a woman to use a condom during sex for the next forty-eight hours if she vomits or has diarrhea within four hours of ingesting Opill. Directives like these could be easily overlooked by anyone but especially by a young person, who may not have a reliable source of information to consult about contraceptives, sex, and pregnancy.
It seems that the NCBC and other cosigners of the letter are right to point out to the FDA that Opill could seriously violate the Hippocratic imperative to “do no harm” without the counsel of a medical doctor. Screening before starting an Opill pack, as well as regular monitoring for side effects while taking it, could do nothing but good for individuals considering Opill. Conversely, for those who are not concerned about the safety of Opill but nevertheless have an interest in preventing unplanned pregnancies and abortions, allowing Opill to be sold over the counter would likely have quite dangerous effects on Americans.
Vivian Tork is studying history and biology at Hillsdale College and is an undergraduate fellow at The National Catholic Bioethics Center.
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