Opinion | Tackling Barriers to OTC Birth Control Pills

Many of the studies and organizations quoted reference women or females for the intended population of contraceptives. We understand that all persons with a uterus, regardless of gender identity and expression, are pregnancy capable and may desire contraception. Language used in this op-ed reflects original study terminology and is not meant to be exclusive.

Earlier this month, an FDA advisory committee unanimously endorsed what could become the first birth-control pill in the U.S. without a prescription. FDA approval is pending. With the leading cause of unintended pregnancy often cited as lack of contraceptive use (or inconsistent use), it is especially crucial to improve access to over the counter (OTC) contraceptive pills. This is only more important as other aspects of reproductive healthcare have been drastically restricted: abortion procedures have been limited or banned in numerous states; ongoing legislative efforts are aimed at curtailing access even further with restrictions on medication abortion; and additional restrictions on access to contraception may be yet to come.

Beyond the importance of approving birth control OTC, in order to truly ensure broader access, it’s also essential to assure the medication is affordable out-of-pocket and to dispel safety misinformation that could stop people from using this form of contraception.

The OTC Cost Dilemma

Approximately one third of adult U.S. women who have ever tried to obtain prescription contraception report barriers to obtaining this prescription, often citing the clinician visit requirement, challenges arriving at the visit, as well as not having a primary clinician. Eliminating the physician requirement with OTC access will most certainly reduce such barriers.

Worldwide, the U.S. is far behind in contraceptive access. Although more than half of U.S. states had legalized pharmacist dispensing of hormonal birth control prior to any recent FDA action for OTC access, this is still lacking compared to other parts of the world. More than 100 countries have had access to OTC oral contraceptive pills without a prescription for over a decade.

National organizations and the public have demonstrated interest in OTC contraceptives during this time frame, with one study reporting over half of U.S. women (62%) interested in OTC birth control pills. However, a concern for costs — more specifically the cost burden shifting from healthcare systems to the individual as an out-of-pocket expense — is correlated with this interest. Nearly all surveyed users would be interested in OTC contraception if costs were to remain at $10 or less per monthly pill pack. That drops down to less than 50% of users once monthly costs increase above $20. Affordable pricing of the medication by pharmaceutical companies will be essential for equal access.

Countering the Safety Critics

Critics of OTC hormonal contraception often quote concerns about safety in their argument about restriction access. These critiques over safety come at a time where several OTC medications — whose approval process was not as onerous or controversial — can cause severe bodily harm and even death if inappropriately consumed. For example, acetaminophen (Tylenol) is consumed by more than 60 million Americans on a weekly basis, and is often used in combination with many other medication formulations, including opioid medication. Acetaminophen toxicity is the most common inciting factor for liver transplantation in the U.S.

Meanwhile, the safety profile of hormonal contraception has been studied consistently for years. When safety concerns are present, the majority of these are related to only one hormone within contraception (estrogen) not progestin. Norgestrel (Opill) — the specific birth control pill the FDA advisory committee supports making available OTC — does not contain any estrogen, and is made up of just norgestrel, a type of progestin.

Norgestrel has been an FDA approved medication — with a prescription — for 50 years, with first approval in 1973. Numerous studies have demonstrated the safety of progesterone contraceptive pills and low prevalence of any contraindications to progesterone. In fact, the only CDC absolute contraindication to progesterone only oral contraceptive pills is active breast cancer, with recent studies demonstrating just 0.57% prevalence of breast cancer in persons seeking preventive and contraceptive services. In that same population, if relative contraindications to the progesterone-only pill are also included — such as history of restrictive bariatric surgery, current anticonvulsive medication, lupus, liver disease/tumors — the prevalence is still only 2.29%, demonstrating that the vast majority of the intended population will not have any contraindications to initiation of progesterone-only contraceptive pills such as Norgestrel. Additionally, numerous studies have demonstrated the ability of individuals interested in contraception to self-screen for any contraindications with over 90% accuracy, some with over 98% concordance compared to providers.

A Step in the Right Direction

Progress towards an FDA approved OTC hormonal contraceptive pill is a long overdue step in the right direction, especially in today’s political and legal climate with unjust restrictions on reproductive rights. As outlined above, the Norgestrel progestin contraception is safe — especially in comparison to pregnancy and other commonly used over-the-counter medication — and potential users have continued to demonstrate knowledge of their own health and potential contraindications to medication. While this decision is a promising step in the right direction, we urge the administration and pharmaceutical companies to carefully review individual costs associated with such a landmark approval. An individual using contraception may use the pill method for months to years, and thus consideration of the long-term monetary investment — and potential to worsen existing disparities in healthcare — cannot be overlooked. It’s time to provide individuals with their bodily autonomy and the ability to make their own reproductive health decisions.

Erin Fleurant, MD, is an ob/gyn undergoing fellowship training in Complex Family Planning at Northwestern McGaw Medical Center in Chicago. Melissa Simon, MD, MPH, is an ob/gyn trained in Complex Family Planning. She serves as vice chair of research in the Department of Obstetrics and Gynecology at Northwestern McGaw Medical Center in Chicago. She is also founder and director of both the Center for Health Equity Transformation and the Chicago Cancer Health Equity Collaborative.