The contraceptive drug norgestrel sold as Opill, which was approved by the FDA decades ago for prescription-only use. If the FDA approves, it would be the first time a birth control pill would be available without a prescription. (Screen capture from FDA)
Dyvia Huitron started having sex when she was 16. Worried about getting pregnant, she talked to her parents about getting on hormonal birth control. Instead, they grounded her.
The now-19-year-old had expected pushback — she was living in a religious community in conservative McAllen, Texas. But she underestimated how many years it would eventually take to get on a reliable form of birth control. She watched a number of friends get pregnant during that time.
“Accessing birth control should not be this complicated,” Huitron told the Food and Drug Administration’s advisory panel tasked with determining whether a low-dose contraceptive pill is safe and effective enough to be recommended for over-the-counter use. “At 16, 17, 18, and now 19 my needs have been unmet, yet have remained the same for years.”
Now a college student in Alabama, Huitron said she still faces barriers to accessing birth control and was among dozens of reproductive health care providers and advocates who publicly testified during the FDA’s two-day hearing on the contraceptive drug norgestrel sold as Opill, which was approved by the FDA decades ago for prescription-only use. Overwhelmingly, public commenters urged the agency to address a lack of access to effective birth control, faced by millions of women and teenagers of reproductive age at a time when options to terminate unintended or risky pregnancies have become extremely diminished.
The FDA advisory committee not only agreed with advocates that improving access to contraception for marginalized groups is a vital public health need, but were convinced by the science presented by drugmaker HRA Pharma that Opill is overwhelmingly safe and effective to take over the counter.
The 17 advisers — whose collective experience includes obstetrics and gynecology, complex family planning, breast cancer, and consumer health behavior — unanimously voted for the FDA to immediately approve Opill over the counter. This would be the first time a birth control pill would be available without a prescription, something many experts on the panel and public testifiers say presents a huge barrier, especially to adolescents and people with less health care access, like people with low literacy.
“Adolescents really urgently need this,” said adolescent medicine specialist Leslie Walker-Harding, one of the advisers, who said teens are intelligent and savvy enough to follow the drug’s label.
And she said she was very comfortable with the drug’s high safety record.
“The safety profile is so good that we would need to take every other medicine off the market, like Benadryl, Ibuprofen, Tylenol, which causes deaths, and people can get any amount of that without any oversight,” Walker-Harding said.
Referred to as “mini pill,” Opill contains only one hormone, progestin, and has been established as having lower health risks than so-called combination contraceptive pills, which contain both progestin and estrogen and carry a risk of blood clots in some populations. Major medical groups, including the American Medical Association, support making the drug over the counter.
The panel’s green light came a day after scrutinizing and meticulously analyzing the HRA Pharma’s studies of over-the-counter use of Opill, which has been around for decades. Many of the advisers addressed flaws with some of the data and studies’ design, as well as concerns that people with contraindications would erroneously take Opill, or that young people or people with trouble reading would not be able to properly follow the drug’s directions and diminish its efficacy, leading to unplanned pregnancies.
People with breast cancer are advised not to take Opill, as are people taking certain medications and herbal supplements, such as St. John’s wort. A key understanding of progestin-only contraceptives — which can be taken by women who are breastfeeding — is that they need to be taken approximately the same time every day, within a three-hour window in order to work effectively.
But advisers determined the benefits in this case vastly outweigh the risks, noting high rates of teen pregnancy and unplanned pregnancy in America, as well as data showing that the current over-the-counter contraceptives, like condoms, sponges, and spermicides, have high failure rates given common incorrect use. In the face of limited options and limited access to health care, many people use nothing for contraception, the experts said. Though, there are increased efforts to bring better and more accessible options to market, including a male contraceptive.
“It is past time for an over-the-counter birth control pill, which has the potential to advance reproductive justice and expand health equity,” said Victoria Nichols, project director of Free the Pill, a project of Ibis Reproductive Health, in a statement following the advisory committee’s vote on Tuesday. “Now, we look to the FDA to follow the committee’s recommendation, in addition to the overwhelming data, and approve the first-ever over-the-counter birth control pill in the U.S. The days of the current prescription requirement are numbered.”
The FDA could approve the drug for over-the-counter use this summer, moving the U.S. in line with at least 100 other countries that offer contraception over the counter. But FDA representatives expressed skepticism with some of the data presented by the drugmakers. The agency — which is currently being sued by anti-abortion activists for its approval of medication abortion 20 years ago appeared to be proceeding with caution.
“The FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively at the nonprescription setting,” said Karen Murry, deputy director of the FDA’s office of nonprescription drugs, during the second day of the advisory hearing on Wednesday.
Though public opposition to approving over-the-counter use of Opill has been limited to a small group of conservative Christian anti-abortion groups, the anti-abortion voice has been loud when it comes to birth control access in the U.S. The same federal Texas judge, Matthew Kacsmaryk, who ruled that medication abortion should be taken off the market based on scientifically unsound claims also recently blocked access to birth control for minors without parental permission.
Some anti-abortion groups like Students for Life of America, falsely conflate certain types of birth control with abortifacients, while simultaneously speaking out against premarital sex. SFLA, which actively fights against access to birth control on college campuses, opposes Opill and suggests that allowing it over the counter will be a boon to sex predators.
“Most parents do agree that reckless distribution of certain products is not in the best interests of children who need to hear from someone other than a salesman or abuser,” said SFLA president Kristan Hawkins. “The FDA should care more about the people who receive a product than the people who want to sell it.”
Now, as the FDA considers the panel’s recommendation, advisers urged the FDA to act quickly, and emphasized being moved by public testimony outlining the public health crisis.
Jacquiline Marcel Blanco, a clinical nurse leader from Washington state, identified herself during Monday’s public comment session as “a person with a uterus who cares for many people with uteruses.”
While Washington state has made efforts to expand abortion access, Blanco said it’s still increasingly difficult to access abortion care because of nationwide bans and delays and provider shortages. One of her recent pregnant patients had to wait eight days to get a life-saving abortion for a pregnancy that was no longer compatible with life, Blanco said. Thus she urged for better efforts to promote pregnancy-prevention, beginning with approving Opill over the counter.
“BIPOC people like me bear the burden of the maternal mortality crisis, being two to three times more likely to die than white peers,” Blanco said. “Preventing unintended pregnancies is the primary recommendation of our global leaders and evidence-based health promotion, and we have failed.”
Our stories may be republished online or in print under Creative Commons license CC BY-NC-ND 4.0. We ask that you edit only for style or to shorten, provide proper attribution and link to our web site. Please see our republishing guidelines for use of photos and graphics.