Thursday’s decision by the Food and Drug Administration to approve the nation’s first over-the-counter oral contraceptive is expected to expand access to birth control for millions of people. But the drug, called Opill, won’t be available for sale right away, and some launch details have yet to be finalized.
This is what we know so far:
When will Opill be on store shelves?
Opill, a progestin-only oral contraceptive, is expected to hit stores in «early 2024,» according to a spokesman for the pill’s maker, Perrigo Co. The maker was unable to offer a more precise timeline for when distribution will begin.
Will customers have to ask pharmacists for Opill?
Not necessarily. Opill was approved by the FDA to be on store shelves like any other over-the-counter drug, such as Tylenol.
“If it’s called over the counter, that means you go in and you can buy it,” said Dani Lynch, owner and pharmacist at Thrifty Pharmacy, an independent pharmacy in Oklahoma City.
Exactly where the product will be placed in a store will be at the discretion of retailers, the Perrigo spokesperson said, as well as whether retailers choose to lock it down with anti-theft protection.
CVS said it did not yet have details about its plans for Opill and Walgreens did not immediately respond to a query from NBC News. Lynch said he intends to keep Opill on the pharmacist’s counter even though a prescription will not be required for it.
“People, especially children, will not ask for guidance,” he said. «I think I’ll keep it behind the counter and then they’ll have to ask, and then we can talk to them about it.»
How much will Opill cost?
Perrigo has not released pricing information, but plans to do so in the coming months, before Opill hits stores.
“We are committed to ensuring that Opill is widely accessible and affordable,” said Frédérique Welgryn, Perrigo’s global vice president of women’s health, in a statement to NBC News. “We are also working on a consumer assistance program to help some women and individuals who would benefit from using Opill, but are having a hard time making ends meet.”
The company said more details about that program will also be announced in the coming months.
Where will it be sold?
Opill is expected to be sold in pharmacies, convenience stores, supermarkets and online, the FDA said. Perrigo is still figuring out which particular online retailers and distributors it will sell through and will advertise them in the coming months, the spokesperson said.
What is Opill’s story?
The FDA first approved Opill as a prescription contraceptive in 1973. Pfizer marketed it for more than 30 years under the name Ovrette before it was discontinued «for commercial reasons only (i.e., not for safety or efficacy reasons). )», according to a informative document on the FDA website.
Known as a «mini-pill» because it contains a single hormone rather than a combination of progestin and estrogen, Opill has extensive safety and efficacy data: it has been found to be 93% effective in preventing pregnancy.
HRA Pharma, a Perrigo company, acquired the rights to the drug nearly a decade ago with the intention of selling it over the counter.
«It’s been a long journey», Welgryn told fortune at the beginning of this year. «And I’m not going to tell you it’s nice and easy, with rainbows and unicorns.»
Several medical groups and reproductive rights advocates hailed the FDA’s approval Thursday. The American College of Obstetricians and Gynecologists called it a «critically important advance in the accessibility of reproductive health care,» and the American Medical Association urged federal regulators to approve more over-the-counter contraceptives.
“It is important that patients have options when choosing what type of birth control works best for them,” Dr. Jesse Ehrenfeld, president of the American Medical Association, said in a statement. «We hope this is only the first of several to be approved, and we urge the FDA to consider applications for the full range of oral contraceptives available for over-the-counter access.»
Meanwhile, more than half of the US states have laws that allow people to get hormonal birth control prescribed by pharmacists, rather than doctors.