Health

FDA approves Opill, first over-the-counter daily oral birth control

By
Social Links for Marc Lallanilla
Published July 13, 2023
Updated July 13, 2023, 11:44 a.m. ET

In a dramatic first, the Food and Drug Administration has approved a daily oral contraceptive available without a prescription.

Consumers can easily buy the drug, named Opill (norgestrel), at grocery stores, convenience markets or drug stores, or online.

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a news release.

Opill, manufactured by HRA Pharma, will be easier for people to get because they won’t need to see a doctor first, thereby eliminating a barrier to birth control.

Roughly half of the 6.1 million pregnancies in the US are unplanned, according to the FDA, and those unplanned pregnancies are linked to health risks for both the mother and the baby.

“Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts,” the FDA said.

The price and the timeline for making Opill available to consumers will be determined by HRA Pharma, which was recently acquired by Perrigo Company.

The road to the drug’s over-the-counter approval was rocky: As recently as May, an FDA advisory committee expressed concern that consumers who should not take norgestrel because of health conditions might not understand the drug label’s warning, according to CNBC.

FDA headquarters
The FDA’s approval of Opill is the first time a daily oral contraceptive has been available over-the-counter in the US. AP

Women with a history of breast cancer, for example, should not take Opill, but studies found that understanding of the drug’s warning label “did not approach the … target threshold,” according to MedPage Today.

“Norgestrel use in consumers with a history of breast cancer and other progestin-sensitive cancers may stimulate growth of progesterone-receptor positive tumor cells and can increase the risk of recurrence,” the FDA explained in a statement.

But the advisory committee eventually decided that the benefits of making norgestrel available without a prescription outweigh the risks to consumers of taking the tablets without a doctor’s advice or supervision.

In part, the committee’s decision was influenced by the problems American women currently face accessing contraceptives or abortion since the Supreme Court issued its abortion ruling last June overturning Roe v. Wade.

image of Opill box
Opill (norgestrel) must be taken daily at roughly the same time each day. AP

Norgestrel has been approved since the 1970s as a prescription-only drug. The tablets must be taken every day at roughly the same time each day.

Opill should not be used by women with a history of breast cancer, and those who have had any other type of cancer should consult a doctor before using the drug.

Opill should also not be used with another birth control product such as another oral contraceptive, a vaginal ring, a contraceptive patch, a contraceptive implant, a contraceptive injection or an intrauterine device.

Additionally, Opill does not work as an emergency contraceptive or “morning-after pill,” and does not prevent pregnancy or sexually transmitted infections after sex.

“When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy,” said Cavazzoni.