Last Thursday, the Food and Drug Administration (FDA) approved the first-ever over-the-counter birth control pill called Opill. This decision will greatly expand access to contraception and could decrease the number of unintended pregnancies across the country by as much as 25%. The decision comes at a time when the FDA is under tremendous scrutiny for their decision to ease restrictions on Mifepristone, one of two medication abortion drugs. Opill will now be available online and in stores without a prescription, but it is up to Congress to ensure that this product is covered by insurance companies without cost-sharing.
What is Opill? Meet the First-Ever OTC Birth Control Pill
Opill is the brand name for the oral contraceptive medication nogestrel, and up until the FDA’s most recent decision it had been approved for prescription use-only for the last fifty years. The decision to move Opill from behind the counter to storefront comes after HRA Pharma filed for approval to remove the contraceptive medication’s prescription requirement. Opill is a once-daily oral contraceptive that contains the hormone progestin, and it is sometimes referred to as the “mini pill” due to its lack of estrogen. Although all birth control pills have similar side effects, progestin-only pills are less likely to increase risk for blood clots, headaches, and nausea.
Is Opill Safe?
Over-the-counter oral contraceptives are not a novel idea. For years, sexual and reproductive health advocates have urged the federal government to join the ranks of more than 100 countries around the world in approving an OTC oral contraceptive. Decades of research support the safety and efficacy of oral contraceptives. In fact, oral contraceptive pills meet the FDA’s standard qualifications for nonprescription status and can be used without assistance from a health care provider. These pills have no significant toxicity if overdosed, they are non-addictive, users can self-manage common side effects like headaches and cramping, and users can take this drug without a physician screening. That said, removing the prescription requirement from Opill does not take health care providers out of the equation. Patients can still seek contraceptive counseling, and other contraceptives like a contraceptive implant or the patch will still require a prescription from a health care provider.
Why Did This Take So Long? – Basically – All-Male Research Panels and the Comstock Act
Birth control is extremely popular, but it is not without controversy. The first birth control pill was approved by the FDA in 1957 as a method to regulate menstruation. Many women today still enjoy the non-contraceptive uses of the pill. But for women in the 1950s, the pill was a way to manage menstruation and covertly protect against unintended pregnancies at a time when women had little control over their reproductive health. In 1960, the FDA approved the sale of Envoid, the first birth control pill to be marketed specifically for contraceptive purposes. According to Planned Parenthood, one out of four married women (under the age of 45) would use the contraceptive pill by 1965. Despite its popularity the first oral contraceptive was subjected to tremendous scrutiny from birth control supporters and naysayers. Two years after its approval, the manufacturer of Envoid received 132 reported of cases of blood clots and eleven of these cases ended in death.
Despite these shocking reports, women who had questions or expressed concerns over their side effects were met with frustrations from their all-male health care providers, who believed their patients to be exaggerating. It took the work of Barbara Seaman- an award-winning-journalist and one of the founders of the National Women’s Health Network, to snap the medical community and the federal government into action. Seaman released her book A Doctor’s Case Against the Pill in 1969, and this book details the lived experiences of women across the United States who took the pill and experienced adverse side effects. Seaman’s book was important for the sole fact that it drew attention to a lack of research, but science would later debunk some of her statements that the contraceptive pill caused cancer or sterility.
Promptly after the release of Seaman’s book, Senator Gaylord Nelson (D-WI) held a series of hearings (later referred to as the Pill Hearings) to investigate the contraceptive pill’s safety. Unfortunately, women were not actually invited to speak at these hearings, but these hearings did spur women to organize and demand that the FDA include transparent labeling on the packaging of oral contraceptives. Born out of the women’s health movement that followed the 1970 Pill Hearings, the National Women’s Health Network held a its first protest at the FDA to honor the women who died due to insufficient information about contraceptive pills.
Unfortunately, transparent labeling and improved research was just half the battle for women’s health advocates. As soon as the first contraceptive pill was approved, conservative lawmakers sprang to action to restrict or ban the sale and use of contraceptive pills under the Comstock Act. First signed into law in 1873, the Comstock Act prohibited the circulation of “obscene or illicit” material. Under this statute, contraceptives were defined as being obscene or illicit, making it a federal crime to disseminate contraception across state lines. These laws would later be struck down by the Supreme Court in its landmark case Griswold v. Connecticut (1965), in which the court decided that anti-birth control laws violated a couple’s right marital privacy. Although this law has not been enforced since the 1960s, many anti-abortion advocates today argue that Mifepristone and other medication abortion drugs should be banned under Comstock.
Despite the controversies that surrounded the earlier iterations of the contraceptive pill, an overwhelming mountain of evidence supports the safety and efficacy of today’s pill.
Access is Key to Health Equity – And Affordability is Essential to Access
Removing the prescription requirement will increase access to contraception for our most vulnerable populations, like people who live in contraceptive deserts. Presently, more than 19 million Americans live in contraceptive deserts. Specifically, low-income women in rural areas are more likely to have fewer contraceptive options due to a scarcity of providers and a lack of access to affordable insurance. By 2024, it is projected that Opill will be available online and in retail pharmacies without the need for prescription. More exciting, Opill has been approved without an age restriction. This is a huge win for sexual and reproductive health advocates, who previously fought the Obama administration over age restrictions for emergency contraception. To reduce the number of teen pregnancies in the United States, it is essential that youths have unrestricted access to full-scale reproductive health care.
The FDA’s decision is hugely important for women’s health care, but contraception is not truly accessible if it is not affordable. At the time this article is being written, the cost of Opill is still unknown. Research from the Kaiser Family Foundation indicates that women’s interest in using OTC contraception is dependent on the price. If the price of Opill is too high, it is likely that women with health insurance will stick with their covered options, and women without insurance may choose to forgo contraception altogether because the cost is not feasible. To ensure that OTC contraception is affordable, the National Women’s Health Network calls on Congress to pass the Affordability is Access Act (AAA). This bill requires insurance plans to cover OTC contraceptives at no extra cost.
Furthermore, the Network urges Congress to pass the Right to Contraception Act to codify a person’s right contraception and bodily autonomy. In their decision to overturn Roe v. Wade and repeal federal abortion protections, the Supreme Court also cast doubt on the constitutionality of past decisions like Griswold v. Connecticut. Just like abortion, there is no federal right to contraception on the books and one swift decision from the Supreme Court could wipe away the progress we’ve made in the last fifty years. The NWHN has been at the frontline of this fight since the early days of the contraceptive pill, and we are dedicated to working towards a future in which contraception is accessible and affordable for everyone.