The first over-the-counter birth control pill in the United States has shipped to retailers nationwide and will go on sale in the coming weeks.
Dublin-based Perrigo announced that the first orders of its drug, Opill, had been shipped to stores across the country, including CVS and Walgreens.
It will be available for pre-order this week at “most major drug stores” starting in late March. It will also be available online on the Opill website.
In both cases, anyone can buy the drug without a prescription after the Food and Drug Administration (FDA) approved Opill for over-the-counter use last July.
According to Perrigo, Opill will be available in one-month and three-month supplies in stores for $19.99 and $49.99.
Opill differs from other oral contraceptives in that it only contains one hormone, progestin, instead of two.
Online, a six-month supply will cost $89.99. One pill should be taken every day at the same time.
Opill has been hailed as “historic” by medical and advocacy groups like Free the Pill and the American College of Obstetricians and Gynecologists, which have been pushing for years to make an over-the-counter birth control pill available at an affordable price.
Meanwhile, some anti-abortion groups go so far as to equate hormonal contraceptives with abortion.
March for Life, the organization behind an annual event in which thousands of pro-life activists descend on Washington, D.C. for an anti-abortion rally, argued for many years that hormonal contraceptives caused abortion.
They call contraceptives, vaginal rings, and other forms of contraception “abortives.”
In the eyes of that group, the use of any contraceptive method that prevents the implantation of a fertilized egg in the uterus is equivalent to an abortion.
Triona Schmelter, executive vice president and president of consumer self-care for Perrigo in the Americas, said, “From an online perspective, it should be available to order almost immediately.”
As for stores, he said “it will take us a few weeks to go through the distribution process, we will ship the product to the retailers’ distribution facilities and then they will ship it to their stores.”
Opill has been used safely for about five decades, but the United States has been an outlier when it comes to making the pills available without a doctor’s order.
Unlike combination pills, Opill does not contain estrogen, which increases the risk of blood clotting several times; progestin-only pills are considered lower risk.
It works by thickening the mucus in the cervix, making it difficult for sperm to enter the uterus and fertilize an egg.
Opill’s upcoming availability comes days after CVS and Walgreen announced they would sell the abortion pill mifepristone.
Progestin-only pills do not prevent ovulation to the same extent as combined birth control pills. Therefore, its effectiveness is slightly lower. Opill has been shown to prevent pregnancy 98 percent of the time.
The FDA’s Over-the-Counter Drugs Advisory Committee and the Urologic and Reproductive Drugs Advisory Committee, which met in May to discuss approval and voted unanimously in favor, had two main concerns about Opill’s designation for over-the-counter use.
The first concern was obesity, which is becoming more prevalent over time. Currently, about four in 10 Americans are considered medically overweight. In 1960, it was closer to 13 percent.
Research has shown that obese women taking oral contraceptives have a higher risk of blood clots, although that link is weaker when it comes to progestin-only pills.
Agency officials said: “Although the original clinical trials for the norgestrel tablet (minipill) do not present data based on weight or BMI, the prevalence of obesity in adults in the United States has changed dramatically since “The original clinical studies were carried out over 50 years.” years ago.’
“The extent to which the effectiveness of (Opill) is diminished in people who are overweight or obese (who together now represent approximately 60% of the US population of reproductive age…) remains unknown,” they added.
FDA officials also worried that making the pill available without a prescription would eliminate the opportunity for doctors to explain to patients the importance of taking the progestin-only pill daily within the same three-hour period, which would increase the risk of missing doses or taking them by mistake. double the doses.
HRA Pharma addressed the concern in a large study called ACCESS, which mimicked an over-the-counter environment to see if people were able to self-screen and take Opill appropriately.
The study found that 93 percent of people taking the minipill did so as scheduled every day.
Ms. Schmelter noted that once Opill is available, customers should be able to find it in the family planning section.
Walgreen’s and CVS have announced they will offer Opill.
CVS spokesman Matt Blanchette said cnn: “Opill will be available on CVS.com and through the CVS Pharmacy app in late March.”
“Starting in early April, more than 7,500 CVS Pharmacy stores will offer Opill and, for added privacy and convenience, customers will be able to choose same-day delivery or buy online and pick up in store.”
Perrigo’s announcement comes days after CVS and Walgreen’s, two of the largest pharmacies in the United States, said they will begin selling the abortion pill mifepristone in several states this month.