Following the Dobbs v. Jackson Supreme Court decision returning abortion policies to individual states, the Food and Drug Administration (FDA) has proposed eliminating the prescription requirement for oral contraceptives and making them available over the counter (OTC). As of now, FDA medical officers and the FDA advisory committee have approved the proposal, and sent it to the FDA commissioner for final approval. But is the proposed switch based on protecting public health—or politics?
Unlike most drugs, oral contraceptives are especially powerful physiologically because they are hormone-based (not simply a drug). Administered hormones mirror natural chemical signals from the endocrine system and brain. The oral contraceptive drug proposed for OTC distribution, for example, contains synthetic progestins which mimic endogenous progesterone activity.
Modern OTC approvals typically have overwhelmingly positive safety records and are mostly meant for the temporary, short-term relief of symptoms or conditions.
Oral contraceptives, by contrast, 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. Indeed, no prescription-grade hormone has ever been proposed as a long-term, daily, OTC product.
Breast cancer is currently the most common non-cutaneous cancer worldwide—surpassing lung cancer for the first time in 2020—and the second-leading cause of cancer death in American women. Studies from the National Cancer Institute have shown that long-term use of progestins may increase the risk and/or exacerbate existing breast cancer. Why wasn't the FDA advisory committee concerned with potentially aggravating already worrisome epidemiology with OTC oral contraceptives? Every prescription refill appointment doubles as a medical visit where clinicians can conduct exams, order mammograms, and make other medical assessments, including appropriate oral contraceptive dose adjustment in women who are overweight or obese.
Furthermore, studies have shown that contraceptives containing progestins have the ability to increase the risk for or worsen existing cervical cancer. Other studies show that women who have used oral contraceptives over five years have as much as a 60 percent higher risk of cervical cancer than women who have never used them, according to the National Cancer Institute based on a 2003 publication from The International Agency for Research on Cancer.
A pap smear (an examination of cells from the cervix) and a physical exam are critical for diagnosing cervical cancer and sexually transmitted diseases. Pap smears are taken regularly when patients visit their OB-GYNs for oral contraceptive prescriptions or refills. If abnormal findings are detected, immediate action can be taken. Perhaps needless to say, OTC availability of oral contraceptives bypasses these procedures.
The FDA should consider psychological side effects as well. Mood and anxiety disorders are vastly overrepresented in women, with major depressive disorder and most anxiety disorders twice as common in women as in men. One important contributor to these differences could potentially be the administration of progestin in oral contraceptives.
There is evidence that progesterone administration can lead to depression and other negative mood symptoms. Progesterone administration can also worsen existing mood symptoms. When investigators looked at the effects of estrogen alone on mood, compared with combined treatment of estrogens and progesterone, some find a beneficial effect. However, when studies separate out the effect of progesterone without estrogen, a negative effect on mood is observed. This is an important distinction because unlike most oral contraceptives, the proposed OTC product is progestin-only. In fact, one 2022 study stated that "one of the most common reasons given for [a prescriber's] discontinuation of oral contraception is changes in mood or an increase in depressive symptoms."
Aside from direct health consequences, policymakers must consider potential unintended consequences for minor children. A physician spokeswoman representing the American College of Gynecology (ACOG) at the FDA meeting advocated for "over-the-counter access to contraception without age restrictions" (emphasis added).
Does FDA agree with ACOG's recommendation? Will it support OTC oral contraceptive distribution "without age restriction?" OTC products could be sold to anyone, and like PlanB, could be made available in vending machines.
Allowing OTC oral contraceptives quickly becomes problematic because kids have limited understanding of microbiology, the signs or symptoms of STDs, or the permanence or lethality of some STDs. At the same time, targeted smartphone and online advertisements of OTC oral contraceptives would more than likely encourage more undisciplined, riskier, and earlier sexual behavior among youth. Poor compliance in kids could also lead to an increase in pregnancies.
The FDA's role is to make data-driven decisions based on public health and drug safety, not to address social concerns or perceived "barriers" to "reproductive health." Existing data indicate that OTC approval could lead to a deluge of negative public health outcomes. The burden is on the FDA to assert beyond doubt that oral contraceptives are safe enough to be used OTC.
If approved by the FDA, making hormonal contraceptives available without medical supervision will be another in a list of recent unscientific federal public health decisions. Much like the Department of Health and Human Services' advocacy of transgender pharmacology in children, this decision seems to be motivated by politics, with no regard for important safety and public health concerns. Assuring drug safety has been a mandated consideration at the FDA since 1938, and ought to supersede any other consideration, including alleged issues regarding the alleged lack of oral contraceptive accessibility.
Does the FDA really expect young girls and women using OTC oral contraceptives to potentially self-monitor multiple kinds of cancers, STDs, psychiatric changes and other serious adverse effects? Requiring professional, medical screenings, follow up visits, education, tests and examinations are not barriers to good health in women and girls, but the best protection. Will the FDA commissioner make access or public health his priority? We will soon find out.
Dr. David Gortler is a pharmacologist and pharmacist who served as senior advisor to the FDA Commissioner for drug safety, science policy, and regulatory affairs. He is a former professor of pharmacology and biotechnology at The Yale University School of Medicine, where he also served as a faculty advisor at the Yale Center of Bioethics. He is currently a fellow at the Ethics and Public Policy Center and at the Brownstone Institute.
The views expressed in this article are the writer's own.
Uncommon Knowledge
Newsweek is committed to challenging conventional wisdom and finding connections in the search for common ground.
Newsweek is committed to challenging conventional wisdom and finding connections in the search for common ground.
