FDA approves first daily over-the-counter birth control pill, Opill – a pharmacist and public health expert explain this new era in contraception

On Thursday the U.S. Food and Drug Administration approved a drugmaker’s application for the first daily over-the-counter birth control pill for people seeking to prevent pregnancy.

The pill, called Opill – the brand name for the tablet formulation of norgestrel – is an oral contraceptive containing only progestin hormone, which helps prevent pregnancy by thickening cervical mucus, preventing ovulation or both.

Opill is expected to be available through pharmacies, supermarkets, convenience stores and online retailers in early 2024. The FDA’s approval of an over-the-counter birth control pill can further expand options for people seeking hormonal contraception to all 50 states and U.S. territories. This expanded access could be a significant development in the post-Roe era as individual states further restrict women’s access to abortion.

Prior to the FDA’s approval of this pill, many U.S. states have allowed pharmacists to prescribe hormonal contraception. The process begins with a pharmacist consultation to screen patients for eligibility, collect a medical history and measure blood pressure. If the patient qualifies, the pharmacist can provide a prescription to the patient; if not, the pharmacist refers the patient to a physician.

I am a pharmacist and a public health expert. I see the move toward over-the-counter birth control as an important step toward accessible and equitable reproductive health care for all Americans. Even though this product will be over-the-counter, pharmacists will play an indispensable role in that effort.

Making birth control more accessible

With more than 60,000 pharmacies nationwide, pharmacists are the most accessible members of the health care workforce. Nearly 90% of Americans live within 5 miles of a pharmacy. Throughout the COVID-19 pandemic, pharmacies have provided testing, vaccination and treatment for millions of people in the U.S., proving their worth in supporting and sustaining initiatives that are important to public health.

Traditionally, hormonal contraception – also known as birth control, or when taken orally, “the pill” – has only been accessible after a comprehensive medical evaluation by a physician, physician assistant or nurse practitioner.

But in 2016, California and Oregon changed their legislation to allow pharmacists to prescribe birth control. That quickly expanded to 20 states, plus Washington, D.C., that now allow pharmacists to prescribe some form of birth control, whether it be the pill, patch, ring or shot.

However, the move toward over-the-counter birth control is important because it will lessen some of the known barriers to birth control, especially if the products are offered at an affordable price point.

These barriers include the inability to pay for medical office visits required to obtain a prescription, lack of insurance to cover the cost of prescription birth control or lack of access to pharmacist-prescribed contraception.

Over-the-counter birth control can also reduce access barriers by preventing the need for a scheduled appointment with a primary care physician during work hours, the need for a pharmacist to be present to dispense prescription birth control or the need to travel long distances to access these professionals.

Addressing remaining barriers

Even in states where pharmacists are currently allowed to prescribe birth control, over-the-counter hormonal birth control can make a difference.

For example, if state policies do not create payment pathways to reimburse pharmacists for their time to counsel and prescribe, pharmacists may choose not to participate in prescribing birth control.

Additionally, pharmacist availability and time may be limited and more restricted than the hours a pharmacy is advertised as open to the public to sell over-the-counter birth control products.

Finally, there are notable cases of pharmacists who have denied patients access to emergency contraception, also known as the “morning-after pill,” and prescriptions for medication abortion on the grounds of moral, ethical and religious beliefs.

For instance, in 2019, a pharmacist in Minnesota denied a patient emergency contraception, citing personal beliefs.

As a result, the patient drove 50 miles to gain access to the medication.

Ultimately, a jury found that the pharmacist did not discriminate against the woman by denying to fill her prescription.

This precedent suggests that pharmacists who object to the use of reproductive medications may further choose not to participate in prescribing hormonal contraception even when permitted to do so by state law.