An advisory panel to the U.S. Food and Drug Administration (FDA) has unanimously endorsed the agency making oral contraceptives available over the counter. If the FDA follows this recommendation, the drug, marketed under the name Opil, will be the first contraceptive available without a prescription in the United States. A final decision by the agency is expected in the next few months.
The two-day meeting, which ended on May 10, was highly anticipated, as FDA often follows advisory recommendations. Groups such as the American College of Obstetricians and Gynecologists (ACOG) and the American Medical Association have urged authorities to make oral contraceptives available over the counter.
“The scientific evidence that access to over-the-counter contraceptives without age restrictions can be safely achieved, and the benefits of increased access are substantial,” said gynecologist Christine Brandy, who will represent ACOG at the conference. Stated. He said many people looking for drugs to prevent unwanted pregnancies face obstacles such as cost barriers and difficulty in getting doctor’s appointments. “People from marginalized communities, including racial and ethnic minorities, the uninsured, and non-English speakers, are more likely to face these barriers,” she said.
Daniel Grossman, director of Advancing New Standards in Reproductive Health (ANSIRH), a research program at the University of California, San Francisco, said the decision was particularly important given recent restrictions on access to abortion in the United States. rice field. “About a third of people in the country have no access to abortion care,” he says. “It is now even more important to remove the barriers that prevent effective contraception.”
Birth control pills are also available over-the-counter in many other countries, but some require a conversation with a pharmacist to obtain. In 2021, two brands of contraceptives will be available over the counter in the UK 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 estrogen.
Opil, known by its generic name norgestrel, is a progestin-only drug. This type of drug poses less risk than, for example, combination drugs that can cause blood clots. Norgestrel was first approved by the FDA in 1973. In June 2022, HRA Pharma, the Paris-based manufacturer of Opil, submitted an application to switch the drug from requiring a healthcare provider’s prescription to not requiring a prescription.
To be marketed over the counter in the United States, certain criteria must be met. It should be used for conditions that the recipient can self-diagnose, in this case a desire to prevent unwanted pregnancies. Also, users should be able to safely and effectively administer the drug without the assistance of a healthcare provider. For Opill, that means taking one tablet each day at the same time. The final criterion is that the drug has a low potential for misuse or abuse.
When applying for a switch to non-prescription status, HRA Pharma will provide FDA with data from studies investigating whether consumers can understand how to use Opill without supervision and accurately identify if they have any contraindications. submitted. These are medical conditions that prevent you from taking the medicine, such as a history of breast cancer.
voices of concern were raised
During the advisory meeting, FDA scientists criticized the data presented by HRA Pharma, particularly the results of studies evaluating how the drug would be used in real-world settings. Scientists questioned the study’s conclusions because about a third of study participants reported taking more pills than were provided. Scientists were also not entirely sure whether users could recognize the contraindications of the tablets.
Scientists at the agency even questioned the efficacy and safety of the drug. They point out that the clinical trials that led to its approval in 1973 might have yielded different results had they been conducted today, leading to an increase in the incidence of obesity and a potential decrease in the drug’s effectiveness. pointed out there is.
Grossman says it’s unusual to bring up the issue. “For this kind of application to move a drug to a prescription-free status, the only thing that matters is whether people are using it properly according to the instructions and whether they can make good choices about whether to use it or not,” he said. says.
The scientists’ scrutiny comes at a time of lawsuits challenging the agency’s decades-old abortion drug mifepristone and its authority. It is unclear whether these concerns will affect the FDA’s final decision on Opil.
Some denied their concerns during the hours when the general public at the conference was allowed to attend. “Women can understand labels that contain contraindications,” said Caroline Lenko, manager of PharmedOut, a project at Washington, D.C.’s Georgetown University that educates doctors about how pharmaceutical companies can affect prescribing. To tell. “Contraceptives are so commonly used that information about the importance of not forgetting or taking them late is common knowledge,” she said. “These patronizing concerns are no reason to deprive women of choice.”
During advisory panel discussions, the panelists acknowledged some of the limitations of HRA Pharma’s data, but ultimately concluded that there is sufficient evidence that the benefits of over-the-counter contraceptives outweigh the risks.
“Do you think we have perfect data? No,” said panel member Cynthia Bauer, an expert in health literacy and health communication at the University of Maryland, College Park. “Do you think it was a perfect study? No. Do you think it was enough to give many people the reassurance that they can use this drug as intended? Yes.”
This article is reprinted with permission and was first published May 11, 2023.
