Birth Control

FDA Considering HRA Pharma’s Opill – Birth Control Pharmacist

Why Over-the-Counter Birth Control?

Oral contraceptives have been around since the 1960s, and their risks and safety profiles have been well studied over the years. According to the Guttmacher Institute, unplanned pregnancies account for 45% of all pregnancies in the US. Furthermore, almost one third of individuals who tried to obtain a prescription for hormonal contraception reported difficulty doing so. Voting from Data for Progress in 2022 shows that a majority of Americans, regardless of political affiliation, support making birth control available over the counter.

The push for over-the-counter (OTC) birth control is driven by the need to expand access to safe and effective contraception. Research shows that women and youth who are uninsured, currently using a less effective contraceptive method, or have tried to get a birth control prescription in the past year are more likely to use OTC birth control. Having birth control over the counter will particularly benefit marginalized communities and individuals who face barriers to health care, such as transportation, cost, language, and lack of access to a doctor.

More than 100 countries around the world have approved OTC birth control options, but as of April 2023 the United States is not one of them. The American College of Obstetricians and Gynecologists, American Medical Association, and American Academy of Family Physicians agreed that oral contraceptives should be approved for OTC use. In June 2022, the encouraged by the FATHER the FDA to approve an OTC contraceptive method with no age restriction.

How Can We Get an OTC Birth Control Option?

In order for a drug to be approved for OTC use by the FDA, definitely standard must be met first. The drug must be safe, treat a condition that patients can self-diagnose, have a low potential for abuse or misuse, and be available for use without the supervision of a health care provider. Oral contraception checks all of these boxes.

The next step is to have a pharmaceutical company produce a product that can be approved by the FDA for OTC use. HRA Pharmaa French pharmaceutical company acquired by Perrigo, is working with Ibis Reproductive Health to bring the Opill product to the US market.

What is Opill?

Opill, the product manufactured by HRA Pharma, is a progestin-only pill for which Ibis and HRA Pharma are seeking FDA approval. If approved, Opill will be the first oral contraceptive available over the counter in the US.

There are two types of oral contraceptives: combination pills (containing both estrogen and progestin) and progestin-only pills. Progestin is a form of the endogenous hormone progesterone, and it plays an important role in the menstrual cycle. Progestin, along with other hormones, help start and stop the menstrual cycle. Low levels of progestin in the body cause the lining of the uterus to shed, which signals the start of menstrual bleeding. High levels of progestin in the body (ie, when you take the progestin-only pill) cause the cervical mucus to thicken, making it harder for sperm to enter the uterus and fertilize an egg.

Progestin-only pills are considered safer than combination oral contraceptives. Because of the pro-coagulatory nature of estrogen, combination oral contraceptives carry the risk of adverse effects related to thromboembolism, or blood clotting. The lack of estrogen in progestin-only pills means that it is preferred in individuals who smoke, have high blood pressure, experience migraines with aura, or are otherwise at risk of blood clots.

On July 11, 2022, HRA Pharma submitted their application for FDA approval of Opill. The FDA review process is expected to take approximately 10 months. Opill has been approved for prescriptive use since 1973, so its safety data has stood the test of time. Traditionally, progestin-only pills should be taken at the same time each day, with only a three-hour grace period before needing back-up contraception (eg, male condoms). However, recently research has found that there is a larger margin of error than previously believed. Because different progestin-only pills contain different types of progestin, they work in the body through different mechanisms. Thus, some progestin-only pills (including norgestrel-only formulations such as Opill) may not adhere to the strict three-hour administration window.

When Can We Expect a Decision from the FDA?

Previously, the FDA planned to conduct a joint meeting on November 18, 2022 with the Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) to review HRA Pharma’s Opill application. This joint meeting was postponed until March 28th of this year, when the FDA announced that it was rescheduling the advisory committee meeting for May 9-10, 2023. May 9th is also Free the Pill Day, which celebrating the anniversary of the first US birth control pill becoming FDA-approved in 1960.

Currently, a national movement involving pharmacists who prescribe hormonal contraceptives is helping to break down barriers to health care and make birth control more accessible. The approval of Opill will go a long way toward removing these barriers and will see a massive expansion of contraceptive access, bringing us one step closer to providing patients with the health care they deserve. them. We anticipate the FDA’s decision as May 2023 approaches.


  1. Abrams A. First US application for an over-the-counter birth control pill. Time. Published July 14, 2022. Accessed April 13, 2023.
  2. Data For Development. Files For Development. Data For Development. Published 2022. Accessed April 14, 2023.
  3. Finer L, Zolna M. Denial of unintended pregnancy in the United States. 2008–2011, New England Journal of Medicine, 2016, 374(9):843–852, doi:10.1056/NEJMsa1506575.
  4. Grindlay K, Grossman D. Interest in Over-the-Counter Access to a Progestin-Only Pill among Women in the United States. Women’s Health Issues. 2018;28(2):144-151. doi:10.1016/j.whi.2017.11.006
  5. Grindlay K, Grossman D. Prescription Birth Control Access Among US Women at Risk for Unintended Pregnancy. J Womens Health (Larchmt). 2016;25(3):249-254. doi:10.1089/jwh.2015.5312
  6. Wollum A, Zuniga C, Blanchard K, Teal S. A commentary on progestin-only pills and the “three-hour window” guidelines: Time of ingestion and mechanisms of action [published online ahead of print, 2023 Feb 19]. Contraception. 2023;109978. doi:10.1016/j.contraception.2023.109978.

Image credit: Image from

MatissaAbout the Author

Matissa Peng, Pharm.D Candidate, is a 3rd-year student pharmacist in the Class of 2023 at the University of the Pacific Thomas J. Long School of Pharmacy. Matissa completed an elective APPE rotation with the Birth Control Pharmacist.

Related Articles

Leave a Reply

Your email address will not be published. Required fields are marked *

Back to top button