FDA considers approval of first over-the-counter birth control pill

This month, the U.S. Food and Drug Administration (FDA) is reviewing an application for over-the-counter birth control. While more than 20 states have already approved dispensation of hormonal birth control without a doctor’s office visit, each state still requires that a licensed pharmacist dispense the medication after reviewing a medical history questionnaire filled out by the patient.

But if the FDA approves French pharmaceutical company HRA Pharma’s “O-pill” progestin-only birth control, it will be available truly over-the-counter just like Tylenol or Motrin — without any doctor, physician assistant, nurse practitioner or pharmacist contact. 

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Advocates claim progestin-only contraception safer than the Pill

While 21 states Attorneys General as well as the American College of Obstetricians and Gynecologists (ACOG) are pushing for FDA approval of OTC birth control (and in ACOG’s case has been pushing for it since 2019) in order to “increase access” to contraception, their full-throated advocacy unfortunately downplays or even ignores important safety considerations.

Progestin-only birth control like O-pill is commonly assumed to be safer than the Pill because it doesn’t contain estrogen, which is associated with an increased risk of serious or even fatal blood clots. But that doesn’t make O-pill or progestin-only birth control harmless and innocuous like the states Attorneys General appear to believe when they parrot the Centers for Disease Control and Prevention’s (CDC) claim that “[n]o examinations or tests are needed before starting progestin-only pills.” The AGs fail to note that the CDC document was last reviewed in 2017, before any formal advocacy for over-the-counter birth control was even on the table. 

According to an Associated Press article, HRA Pharma cited seven years of safety studies as proof of O-pill’s appropriateness for OTC use, but while many women take hormonal birth control for years, even decades on and off, the company’s largest study followed 1,000 women for just six months. Some of the research was funded in part by the contraception advocacy organization Oral Contraceptives Over-the-Counter Working Group, according to the Associated Press. 

Side effects of progestin-only contraception

Research suggests that women who take progestin-only birth control are at increased risk of developing breast cancer, cervical cancer, and brain cancer, and a 2015 study found that glioma risk nearly tripled for women taking progestin-only birth control when compared to women who had never taken hormonal contraception. 

Furthermore, while ectopic pregnancy occurs in 2-5% of pregnancies in the general population, 10% of women who conceived while taking progestin-only contraception experienced ectopic pregnancies. Besides ectopic pregnancy, the O-pill product label also contains warnings about ovarian cysts, irregular bleeding (reported by nearly half of women in HRA Pharma’s clinical trials, and cited as the primary reason for stopping the drug by ⅔ of the 17.4% of studied women who discontinued the medication for side effects), and liver disease. 

Other common side effects in research studies included “Headache, Dizziness, Nausea, Increased appetite, Abdominal pain, cramps and bloating, Fatigue, Vaginal discharge, Dysmenorrhea (painful periods), Nervousness, Backache, Breast discomfort, Acne.” 

Progestin-only hormonal birth control, like the Pill, is also known to increase depression risk, especially in young women. 

Other issues with OTC birth control

OTC contraception access could have negative repercussions for the already high rates of multiple sexually transmitted infections (STIs), since STIs are often diagnosed during contraception office visits. Healthcare providers (repeating the claims of mainstream medical organizations like ACOG) already often downplay the significant risks associated with hormonal contraceptive use. Making hormonal birth control OTC is likely to give users a false sense of security and safety. 

O-pill has the potential to be abortifacient

While the Pill works primarily by stopping ovulation, O-pill functions differently, preventing ovulation in only about half of users’ cycles, according to Rxlist.com. Its consistent mechanisms of action include “thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium,” according to the product label. In other words, breakthrough ovulation is not only possible but expected to occur in about half of cycles. If sperm does get through the thickened cervical mucus and conception occurs, O-pill’s backup mechanism of action, thinning the uterine lining (the endometrium) would make the pill abortifacient, preventing a newly created blastocyst from implanting in the uterine wall. 

Contraception is inextricably linked to abortion

While abortion advocates routinely insist that contraceptive access is the linchpin for decreasing abortion rates, the reality is that contraception and abortion are inextricably linked. A former Planned Parenthood manager called them “two sides of the same coin.” Tellingly, the AP article acknowledged that advocates for OTC contraception see this as a necessary step towards OTC abortion. 

The FDA’s decision is expected in the first part of 2023.