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The Biden-Harris administration just announced a proposed rule mandating free insurance coverage for over-the-counter (OTC) contraception. But the rule has no hope of finalization before the election or even before the next presidential term. It is nothing more than a politically convenient PR stunt for Kamala Harris’ floundering presidential campaign.
“Reproductive rights” has been a rallying cry for the Harris-Walz campaign, even as the vice president refuses to answer questions about her policy positions or explain how a Harris administration would differ from Joe Biden’s.
And now, as touted in news media, a series of press releases by the White House and the Department of Health and Human Services, and most notably a statement by Vice President Harris, the Biden-Harris administration (which, for all intents and purposes, now functions as an arm of the Harris presidential campaign) commits to providing free over-the-counter contraception.
This proposal is a solution in search of a problem, meant to help Harris clinch cheap political points.
While the proposed rule would cover all OTC contraceptive options, including condoms, Plan B, spermicides, and birth control sponges, the spotlight is on the recently approved Opill, a progestin-only contraceptive pill that made headlines in 2023 as the first-ever OTC form of hormonal birth control in the U.S. And while Opill, manufactured by drugmaker Perrigo, has been available for purchase online and in stores since March 2024, the Biden-Harris administration’s proposed rule would mean an unprecedented level of access to a drug with no age restrictions.
This lack of age restrictions was celebrated as a “big victory” upon Opill’s approval, but in its initial review of the drug, the FDA raised questions about whether adult women, much less teens, would understand its labeling instructions and warnings.
In fact, in the FDA’s initial review of Perrigo’s application for OTC approval, the agency flagged issues with study participants’ adherence to Opill’s regimen (to be effective, the drug must be taken at the same time each day), as well as participants’ understanding of whether the drug was appropriate for them, given their particular health profile and risk factors.
Indeed, Perrigo’s study revealed issues on both fronts. Its data indicated that 30 percent of study participants recorded taking more pills than the researchers actually provided. Furthermore, Opill’s labeling states that women with a history of breast cancer shouldn’t take the drug and that women with “unusual vaginal bleeding” should talk to a doctor before taking it—something that is not required for over-the-counter drugs—yet some women in both camps still incorrectly believed that Opill would be safe and appropriate for them to use.
Importantly, the ages of the women studied by the manufacturer is unclear—did they, for example, determine whether a 12-year-old (the average age of menarche for American girls) could appropriately decide whether Opill is right for her? It would appear not. The FDA label for Opill states under “Pediatric Use,” that:
In addition to the concerns posed by the lack of age restrictions for the use of this drug, the risks associated with Opill are consistent with those of other forms of hormonal contraception, including but not limited to: increased risk of breast cancer, cervical cancer, brain cancer, depression, high blood pressure, and ulcerative colitis. As Dr. David Gortler, a former FDA drug safety official, pointed out, “OTC approvals…are mostly meant for the temporary, short-term relief of symptoms or conditions,” but OTC contraceptives “are a long-term hormonal product meant to be taken daily—potentially for years or decades—and have been directly correlated with serious medical risks that require oversight by a licensed prescriber.”
While the Biden-Harris administration’s recent play to bolster Harris’ anemic presidential campaign may be just that, it’s indicative of the Left’s lack of seriousness when it comes to providing the kind of health care that women actually want and need. Claiming to support women’s reproductive health, the administration plays fast and loose with the safety of young women and adolescent girls in order to score cheap points for itself and taxpayer dollars for its friends in Big Pharma. For Harris (and for drug companies), your 12-year-old’s ability to get drugs for free with no parental, physician, or pharmacist oversight might be a “big victory.” But it’s a serious concern for the health and safety of young women.
Natalie Dodson is a Policy Analyst with the Ethics and Public Policy Center’s HHS Accountability Project. Grace Emily Stark holds an M.A. in Bioethics & Health Policy from Loyola Chicago and is the Editor-in-Chief of Natural Womanhood, “The Magazine of Fertility Awareness and Women’s Health.”
The views expressed in this article are the writers’ own.