On July 11, France-based HRA Pharma submitted their Prescription-to-Nonprescription (Rx to OTC) Switch Application to the FDA, hoping to be the first providers of an over-the-counter oral birth control in the United States. The drug is currently on the market as OpillTM and requires a prescription, whereas the company’s UK version, under the name Hana, is available without a doctor’s order.
OpillTM is a progesterone only pill or “minipill”, rather than a combination of progesterone and estrogen. The active ingredient is a synthetic progesterone called norgestrel, which works to prevent pregnancy by preventing ovulation and thickening the cervical mucus. During the normal menstrual cycle, fluctuations in estrogen and progesterone signal to the body that it should either prepare for a pregnancy or reset the cycle.
These hormones communicate through a negative feedback system with other parts of the body, including the brain. This system is called the Hypothalamic-Pituitary-Gonadal (HPG) Axis.. In this process, the hypothalamus signals to the pituitary, which in turn communicates to the gonads (in this case, the ovaries), which produce estrogen and progesterone. When the body senses these hormones, it signals back to the hypothalamus to stop signaling the pituitary, hence the name negative feedback.
By adding exogenous (“outside the body”) progesterone, the feedback loop that exists between the brain and the reproductive system senses the presence of progesterone and downregulates the actions of the hypothalamus. In doing so, it also downregulates another important hormone called luteinizing hormone (LH), which is responsible for ovulation and ovulation is blocked.
Oral birth control has been around for over sixty years, and progesterone only pills are safe for the majority of reproductive-aged patients, including those who should not take the combination, estrogen-containing pill. This may give HRA Pharma an advantage in the approval of their application, which is expected to be under review for the next ten months.
HRA Pharma’s application followed on the heels of the Supreme Court’s June 24th ruling in Dobbs v. Jackson that overturned federal protection of abortion. With abortion now restricted or banned in many states, the potential for over-the-counter birth control is certainly invigorating news in the push for reproductive justice. However, improving birth control access will not negate the need for comprehensive, safe, and informed sexual healthcare, including abortion.
The pill’s 91% efficacy in real world use is great. But what about the 9% of people who have a birth control failure? The work to move birth control over the counter must be done in parallel to the work advocating for legal abortion. Both are equally important, and neither negates the other. As one of my previous professors said, “As long as people are having sex, we will need abortions.”
That being said, moving OpillTM and other pills over-the-counter is an important step in achieving accessible, equitable health care. Eliminating barriers to using the birth control pill will empower people to control their own fertility. Historically, contraception, and the pill specifically, has been used to suppress vulnerable populations. Shifting oral contraceptives over-the-counter can alleviate hesitation in seeking a prescription and having to juggle a provider’s prejudice. It also reduces barriers such as taking time off work or finding alternative family care arrangements that are necessary when making an appointment at a physician’s office.
There is so much to benefit from OpillTM potentially coming onto pharmacy shelves, and we hope that HRA Pharma’s data, collected with help from Ibis Reproductive Health and others in the Free the Pill Coalition, will be enough to prove the safety and efficacy to the FDA.
I am a graduate of Boston University and a first-year PhD pre-candidate at the University of Michigan. My interests combine biomedical engineering and reproductive health.