The Food and Drug Administration approved that the birth control pill Opill — generically known as norgestrel — can be sold over the counter on Thursday. This is the first oral contraceptive to be dispensed without a prescription in the U.S.
“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,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release.
What exactly is Opill?
Opill is a type of hormonal birth control pill that prevents pregnancy primarily by thickening cervical mucus to keep sperm from reaching an egg. It’s what’s known as a “minipill,” meaning it contains only a synthetic form of the hormone progesterone — unlike more commonly prescribed combination birth control pills, which contain both progesterone and estrogen. The FDA approved Opill as a prescription drug in 1973, but in other countries, such as the United Kingdom, it’s available without a prescription.
Now that Opill has been approved to be sold over-the-counter, how will it work?
Dr. Paul Blumenthal, a professor of ob-gyn at Stanford University, tells Yahoo Life that Opill will be available just like any other OTC drug. Opill will be available at convenience stores, drug stores, grocery stores and online. The timeline for availability and price will be determined by the manufacturer, Laboratoire HRA Pharma, the FDA stated.
“It would be similar to if someone went to their local pharmacy and bought medication like ibuprofen or Tylenol without a prescription,” Dr. Gopika Krishna, a family planning expert and fellow in ob-gyn at Columbia University, tells Yahoo Life.
Opill drugmaker Perrigo hasn’t publicly disclosed how much over-the-counter Opill would cost. OTC drugs tend to be cheaper than prescription medicines, though they’re not covered by insurance.
Why was it approved?
For the FDA to approve a drug to be available without a prescription, the drug’s applicant must demonstrate that the “product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional.” Studies conducted showed that consumers had a high understanding of the Opill Drug Facts instructions, which requires users to take the medication within the same three-hour window every day, as minipills are less forgiving of missed or late pills than combination birth control pills.
The FDA did express concerns though initially, with officials worried that users may not recognize on their own that certain conditions would make Opill inappropriate for them. Women with a history of breast cancer or undiagnosed abnormal vaginal bleeding, for example, shouldn’t take the drug.
The FDA also expressed concern that Opill may be less effective in women who are overweight, citing studies about emergency contraception. On its website, Planned Parenthood says that emergency contraception like Plan B isn’t as effective if you weigh more than 165 pounds. But the American College of Obstetricians and Gynecologists’ practice guidelines state that “women with obesity can be offered all hormonal contraceptive method options with reassurance that the efficacy of hormonal contraception is not significantly affected by weight.”
What do parents need to know?
Blumenthal says it’s important for parents of teens to understand that Opill is safe and effective — “and we have over 50 years of experience to prove it.”
“Preventing an unintended pregnancy if you are a sexually active teen is a very important investment in being able to achieve your life goals, and parents need to recognize this even if they prefer that their teen not be sexually active,” he says.
Opill’s application was approved without any age restrictions. Emergency contraceptives like Plan B, for example, initially had restrictions for children under 16, but those age limits were eventually removed.
“Multiple medication organizations, including the American College of Obstetricians and Gynecologists, have supported access to OTC contraception without age restriction,” Krishna says. “Adolescents can face significant barriers to accessing contraception, so it is important to support increasing access to contraceptive methods.”
What could this mean for birth control pills going forward?
The move to make birth control pills easily accessible is gaining steam, with Arizona passing legislation in July allowing pharmacists to dispense OTC contraceptives. Opill’s approval should open the door for more OTC birth control options in the future.
“I think we may have cracked the glass ceiling for OTC contraception with hormonal contraceptives in the U.S.,” Blumenthal says. “In many other countries, OTC status of not only progestin-only pills but also combined oral contraceptives has been a fact for years, if not decades, so it’s high time we caught up with this global trend.”
Nonprescription availability of Opill may reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to first see a health care provider. Almost half of the 6.1 million pregnancies in the U.S. each year are unintended. Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes. Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts.
