When your body is not your choice anymore and nearly half of all pregnancies in the US are unplanned, protection is vital. Opill, America’s first over-the-counter (OTC) oral contraceptive by Perrigo will be available early next year. Is Perrigo’s new drug going to be a hit among American women?

Republicans: Pro-life and pro-protection?

In June 2022, the Supreme Court overturned Roe versus Wade, which means that there is no longer a federal constitutional right to abortion; states can ban abortion. Republicans took on this opportunity enthusiastically; in 22 states it is either illegal or very difficult to get an abortion.

However, this Republican-backed pro-life movement was not supported as enthusiastically by the majority of Americans. When interrogated about abortion rights, the topic of easy contraception access is a quick defence tactic for Republican Representatives seeking to entice female voters.

In Iowa, a state that is vying to ban abortion after six weeks of pregnancy, Republican Marianette Miller-Meeks boasted about her sponsoring of the recent introduction of the Orally Taken Contraception Act of 2023.

This act aims to pave the way for women’s access to OTC oral contraceptives, and the Food and Drug Administration (FDA) is obliged to share details of OTC’s approval to other providers of oral contraceptives. If all goes to plan, Opill will face competition providing a variety of cost-effective birth control options for women.

Is the Act’s promise a political tactic or a timely development?

Opill is certainly an attractive drug; not only is it available for all ages but the contraceptive pill is currently a popular form of contraception in the US.

For those lucky enough to be insured, Opill is a means to get birth control discretely without fearing the consequences of an insurance letter appearing at their disapproving family’s doorsteps. Currently, eight states demand that health insurance plans cover OTC contraceptives. However, the insurance companies that are free of state control are not obligated to include this offer.

For Opill to be an integral part of the American breakfast, eyes are on the federal government to put into action its plans to obligate all health insurance companies to cover FDA-approved OTC birth control.

For those without health insurance, who live far from a doctor, or who are faced with language barriers, Ophill’s accessibility depends heavily on its yet-to-be-determined price. Perrigo has described a ‘Consumer Assistance Program’, which would enable eligible women to obtain Opill for free. However, uncertainty lies around this as Perrigo has, as of yet, not gone into more detail.

If the Orally Taken Contraception Act’s aims of creating market competition are effective, this may offer a solution to the high prices. For the plan to be more than an immaterial act and the OTC contraceptive to be a hit, accessibility is key.

Opill: accessible but leaving women alone?

The trend towards obtaining oral contraceptives without a doctor’s input raises concerns, such as patients not understanding potential side effects. The Orally Taken Contraception Act requires that the labelling of OTC contraceptives is simplified—these clear instructions on use and potential side effects will offer women increased awareness.

However, the full extent of the side effects of oral birth control is still not understood. Further research is necessary. For example, increasing evidence from GlobalData reveals the psychological risks of the contraceptive pill. Anna Moody,  epidemiologist at GlobalData, describes how part of its predictions for the increase in women with depression over 18 years old in the UK (from 8.6 million in 2023 to 8,9 million in 2032) is due to the increase in hormonal contraceptives taken and the lack of associated education. Importantly, Moody notes that during a prescription of hormonal contraceptives, it is vital that there is an evaluation of which methods are best for the patient and that there is transparency on both the physical and psychological side effects. There should be a discussion about the woman’s susceptibility to mental health risks and any relevant family history. GlobalData’s recent thematic report on Femtech further highlights the significant unmet needs in female healthcare.

If women are left behind with no doctor’s input on their personal susceptibilities before taking Opill, there is a risk of an increase in depression cases in women in the US. The current consensus in the US is “the benefits outweigh the risks”, but questions remain: Do these benefits only outweigh the risks in pro-life America? And are women, especially those without insurance, being left behind to face risks alone?