The Food and Drug Administration’s panel of experts has unanimously recommended that women be allowed to purchase a birth control pill without a prescription, which is a first for the agency. HRA Pharma has applied for permission to sell its Opill over-the-counter and expects the FDA to make a final decision this summer. If approved, Opill would be the first birth control pill to be sold in the United States without a prescription in more than 60 years. However, FDA scientists have expressed concerns about whether the drug label will be properly understood by the general public and whether HRA Pharma’s Opill will be used correctly.
On Wednesday, a panel of experts who advised the US Food and Drug Administration (FDA) unanimously recommended allowing women to obtain a birth control pill without a prescription for the first time. The panel was tasked with evaluating whether the benefits of HRA Pharma’s birth control pill, Opill, outweighed the risks of consumers improperly using the medication and experiencing an unintended pregnancy. The FDA is not required to follow the recommendations of its 17 independent advisors, who all voted in favor of the proposal after a two-day hearing. However, HRA Pharma, which is owned by Perrigo, a manufacturer of over-the-counter drugs, anticipates a final decision from the FDA this summer on its application for non-prescription sales of Opill (also known as norgestrel).
For more than 60 years, oral contraceptives have only been available in the United States to women with a prescription. However, if the FDA approves HRA Pharma’s application, Opill will be available over the counter, enabling women to obtain it without having to visit a doctor or other health care provider. Dr. Katalin Roth, a member of the FDA advisory panel and a professor of medicine at George Washington University, said, “The history of women’s contraception is a struggle for women’s control over their reproduction, and we need to trust women.” She urged the FDA to approve the over-the-counter availability of Opill. HRA Pharma updated the pill’s label in 2017 in hopes of reintroducing the medication to the U.S. market as an over-the-counter drug. Medical associations, such as the American College of Obstetricians and Gynecologists, have been advocating for over-the-counter sales of birth control pills for years. In March 2022, more than 50 members of Congress urged FDA Commissioner Dr. Robert Califf to ensure the agency reviewed applications for over-the-counter birth control pills without delay. They noted that despite decades of proven safety and effectiveness, systemic inequities in the healthcare system prevent people from getting birth control, leading to unintended pregnancies. A New England Journal of Medicine study published in 2016 found that nearly half of all pregnancies in the U.S. were unintended in 2011.
According to a study, 75% of all pregnancies among girls aged 15 to 19 years were unintended. HRA Pharma submitted its application to the FDA last summer, two weeks after the Supreme Court overturned its landmark 1973 Roe v. Wade decision, thereby abolishing federal abortion rights. The fall of Roe v. Wade resulted in some states banning or tightly restricting abortion and also led to legal efforts to pull abortion medication from the U.S. market. As access to abortion shrank across the U.S., there were renewed calls for expanded access to birth control to prevent unintended pregnancies.
FDA Raises Questions About Company’s Data
Norgestrel is a birth control pill that contains progestin hormone, which thickens the cervix mucus to prevent sperm from fertilizing an egg, thus avoiding pregnancy. It needs to be taken daily at the same time. Progestin-only pills are preferred by women who cannot take combination pills that contain both progestin and estrogen due to health concerns. While progestin-only pills are an effective method of birth control, it’s crucial to take them at the same time every day, as stated by the American College of Obstetricians and Gynecologists. In typical use, approximately 9 out of 100 women may get pregnant during the first year of using the pill, but when taken consistently, fewer than 1 in 100 women may get pregnant during the first year.
The FDA has expressed concern about the understanding and proper use of norgestrel’s drug label, particularly among adolescents and individuals with lower literacy levels. The agency also discovered that one-third of participants in HRA Pharma’s study took more norgestrel pills than were dispensed, casting doubt on the reliability of the study’s other data. The FDA has been tasked with determining whether it is likely that women will safely and effectively use the product in a non-prescription setting. Despite these concerns, Kathryn Curtis, an FDA committee member, and scientist at the Centers for Disease Control and Prevention, believes that the benefits of over-the-counter birth control outweigh the risks.
Let’s Not Use Women as Hostages
The FDA expressed concerns about HRA Pharma’s drug label comprehension study, where some women with a history of breast cancer chose to take norgestrel despite warnings not to. The use of progestin can increase the risk of breast cancer returning, and the agency’s scientists were worried about the medication’s potential misuse by women with unexplained vaginal bleeding between menstrual cycles who didn’t consult a doctor first. Dr. Pamela Goodwin, an oncologist, and Dr. Anna Glasier, an expert on reproductive medicine, both presented for HRA Pharma and addressed these concerns. Goodwin explained that most women diagnosed with breast cancer are older than reproductive age, and those of reproductive age are unlikely to use a medication that would increase their risk of cancer returning. Glasier argued that unexplained vaginal bleeding is common and usually resolves spontaneously, and it shouldn’t prevent women from accessing effective progestin-only birth control pills like norgestrel without having to consult a doctor.