- FDA advisers voted unanimously to recommend the first OTC birth control be approved.
- The FDA is expected to make a final decision this summer.
- Making this medication available OTC will greatly increase access to birth control and help millions of women and people with uteruses combat unintended pregnancies, health experts say.
Advisers for the Food and Drug Administration (FDA) unanimously voted to approve the first over-the-counter (OTC) birth control pill Wednesday.
Two advisory panels — Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (ORUDAC) — met May 9 and May 10 to review and discuss the application for the once-daily oral contraceptive.
The panels voted that people could use the medication, called Opill, safely and effectively without the help of a healthcare worker and agreed that the benefits outweigh the risks.
The FDA is expected to make a final decision this summer.
Opill was first approved by the FDA in 1973 and evidence has consistently shown that the medication is safe and effective.
Making this medication available OTC will greatly increase access to birth control and help millions of women and people with uteruses combat unintended pregnancies, health experts say.
“This is a very positive step. Birth control pills have been available over the counter in many other countries for some time, and this helps bring that same accessibility to people in the US,” Sarah McBane, PharmD, associate dean of pharmacy education at University of California, Irvine’s School of Pharmacy & Pharmaceutical Sciences, told Healthline.
What Opill is and how it works
Opill, produced by the drugmaker Perrigo, contains 0.075 milligrams of a synthetic progestin called norgestrel.
“It works the same way as other progestin-only contraceptives; mainly by preventing ovulation,” says McBane.
Progestin-only contraceptives also prevent pregnancy by thickening the cervical mucus, altering the endometrium, slowing the movement of the ovum through the fallopian tubes, and lowering hormones throughout the cycle.
In clinical studies, oral contraceptive pills are about 98% effective, however, once you account for real-world factors — like remembering to take the pill at the same time every day and having the prescription refilled on time — that number is more like 93%, says Dr. Tessa Madden, an OB/GYN and chief of family planning at Yale Medicine.
Progestin-only birth control pills are also very safe with few medical contraindications, says Madden.
“Almost all women can safely take progestin-only birth control pills,” Madden says. “In addition, this birth control has been approved for use for many years with a prescription.”
It’s a good option for people who cannot take combined hormonal contraceptives because they have to avoid estrogen, says McBane.
Studies have also found that people can safely screen themselves to determine if they have any contraindications.
OTC Opill would expand access and prevent unintended pregnancies
By removing the requirement to see a healthcare provider, health officials can significantly expand access to birth control.
Research has shown that many people face barriers accessing contraceptives, especially when it comes to scheduling appointments or getting their prescription refilled.
“Opill, as an OTC, would not be hindered by either of these issues,” says McBane.
Having more birth control options that are easily accessible will help more people find a contraceptive that works for them, she added.
A 2022 survey from the Kaiser Family Foundation shows that most women, about 77%, support birth control being available OTC if research says it’s safe and effective.
Unintended pregnancy continues to be a massive public health issue in the U.S.
Women who have unintended pregnancies are more likely to delay prenatal care, experience violence, and have mental health problems.
“Having a birth control available over the counter would increase access to contraception, especially for patient populations who might already experience barriers to accessing reproductive health care such as those with limited financial means, who lack health insurance, or who live in a rural area where there may be limited access to a healthcare provider willing to prescribe birth control pills,” says Madden.
This is not a guarantee the FDA will approve the pill for OTC use
The FDA is expected to make a final decision this summer.
Madden says today is an important step in the approval process, but she remains concerned about what the FDA’s call will be.
During the initial review of evidence, the FDA raised concerns that some patients may not be able to determine if Opill is appropriate for them.
“Scientists also raised concerns about users’ ability to follow packaging directions, although this would be no different than pills that currently require prescriptions,” Madden said.
The FDA isn’t required to follow the advice of the panels, but often does.
“In this case, the FDA approval has the potential to improve contraceptive access, especially after the Dobbs case which has restricted individuals access to abortion in 15 states,” Madden said.
The bottom line:
Advisers for the FDA unanimously voted to approve the first over-the-counter birth control pill, Opill. The panels voted that people could use Opill safely and effectively without the help of a healthcare worker and agreed that the benefits outweigh the risks. Having an OTC contraceptive would greatly expand access to birth control and help prevent unintended pregnancies, which are linked to physical and mental health problems along with social and financial stress. The FDA is expected to make a final decision this summer.
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