FDA Approves the First Birth-Control Pill for Over-the-Counter Access

approved a birth-control pill called Opill for use without a prescription on Thursday. It’s now the first daily oral contraceptive to be sold in the U.S. without a prescription at drug stores, convenience stores and online. This May 2023 story describes the approval process for Opill and early support for the then pending decision.

An advisory committee for the US Food and Drug Administration (FDA) has unanimously endorsed the agency making an oral contraceptive available over the counter. If the FDA follows this advice, the medication, sold under the name Opill, will be the first birth-control pill available without prescription in the United States. A final decision by the agency is expected in the coming months.

Because the FDA often follows its advisers’ recommendations, the two-day meeting, which ended on 10 May, was hotly anticipated. Associations such as the American College of Obstetricians and Gynecologists (ACOG) and the American Medical Association have been urging the agency to make oral contraceptives available over the counter.

“The scientific evidence is clear that over-the-counter access to contraception without age restrictions can be accomplished safely, and the benefit of increased access is significant,” said Kristyn Brandi, a gynaecologist representing ACOG at the meeting. She pointed out that many people seeking medication to prevent unwanted pregnancies face obstacles, including cost barriers and difficulties in obtaining an appointment with a physician. “People from marginalized communities, including racial and ethnic minorities, uninsured people and those who don’t speak English, are more likely to face these barriers,” she said.

Related: Over-The-Counter Birth Control Pills Have Been Approved. Let’s Make Them Inexpensive and Easily Available

The decision is especially important in the light of recent restrictions on abortion access in the United States, says Daniel Grossman, director of Advancing New Standards in Reproductive Health (ANSIRH), a research programme at the University of California, San Francisco. “People in about one-third of the country can’t access abortion care,” he says. “Now it’s even more important that remaining barriers to effective contraception are removed.”

Oral contraceptives are available over the counter in many other countries, although access to some requires a conversation with a pharmacist. In 2021, two brands of contraceptive pill became available without prescription in the United Kingdom, with only this requirement.

No prescription needed

There are two types of hormone-based birth control: one contains progestin, a synthetic form of the hormone progesterone, and the other uses a combination of progestin and the hormone oestrogen.

Opill, known by the generic name norgestrel, is a progestin-only medication. This type of drug has fewer risks compared with the combination pills, which have been associated with blood clots, for example. Norgestrel was first approved by the FDA in 1973. In June 2022, Opill’s maker, HRA Pharma, based in Paris, filed an application to switch the medication from requiring a health-care provider’s prescription to not needing one.

To be sold over the counter in the United States, a drug must meet certain criteria. It should be used for a condition that the recipient can self-diagnose — in this case, the desire to prevent an unwanted pregnancy. The user should also be able to administer the drug safely and effectively without the help of a health-care provider. With Opill, that means taking one pill every day at the same time. The last criterion is that the drug should have a low potential for misuse and abuse.

In applying for the switch to non-prescription status, HRA Pharma submitted data to the FDA from studies probing whether consumers understand how to use Opill without supervision and can correctly identify whether they have any contraindications. These are medical conditions, such as a history of breast cancer, that would preclude them from taking the drug.

Concerns raised

During the advisory meeting, FDA scientists criticized the data presented by HRA Pharma, especially the results of the study evaluating how the drug might be used in a real-world setting. About one-third of the study participants reported taking more pills than were made available to them, which prompted the scientists to question the study’s conclusions. The scientists were also not completely convinced that users were capable of recognizing that they had contraindications for the pill.

The agency scientists even questioned the efficacy and safety of the drug. They noted that the clinical trials that led to its approval in 1973 might have had different results if they were conducted today, citing an increased incidence of obesity that could potentially lower the medication’s efficacy.

It is unusual to bring up this issue, Grossman says. “With this kind of application to move a medication to non-prescription status, the only thing you should be looking at is whether people use it appropriately, according to the instructions and whether they can appropriately select for use or not,” he says.

The scientists’ intense scrutiny comes at a time when a lawsuit is challenging the agency’s decades-ago approval of the abortion pill mifepristone — as well as its authority. It’s unclear whether these concerns will affect the FDA’s final decision on Opill.

During the portion of the meeting when members of the public could participate, some pushed back on the concerns. “Women can understand labels, including contraindications,” said Caroline Renko, a manager at PharmedOut, a project at Georgetown University in Washington DC that educates physicians about how pharmaceutical companies influence prescribing. “Birth-control pills are so commonly used that information regarding the importance of not missing doses or taking doses late is common knowledge,” she said. “These patronizing concerns are not grounds to take away a woman’s choice from her.”

During the advisory committee’s discussion, panellists acknowledged some of the limitations of the HRA Pharma data but ultimately concluded that enough evidence exists that the benefits of having an over-the-counter contraceptive pill outweigh the risks.

”Do I think that we’ve got perfect data? No,” said committee member Cynthia Baur, a health literacy and health-communication specialist at the University of Maryland in College Park. “Do I think it was a perfect study? No. Do I think it was adequate to feel reassured that a large number of people can use this drug as intended? Yes.”

This article is reproduced with permission and was first published on May 11, 2023.