America’s first over-the-counter birth control pill has been shipped to retailers across the country and will go on sale in the coming weeks.
Dublin-based company Perrigo announced that the first orders of its drug, Opill, had been shipped to stores across the country, including CVS and Walgreens.
It can be reserved this week from the end of March at ‘most major pharmacies’. It will also be available online on Opill’s website.
In either case, anyone can buy the drug without a prescription after the Food and Drug Administration (FDA) approved Opill for OTC use last July.
According to Perrigo, Opill will be available in stores for one and three months for $19.99 and $49.99.
Opill differs from other oral contraceptives in that it contains only one hormone – progestin – instead of two
Online, a six-month supply costs $89.99. You are supposed to take one pill at the same time every day.
Opill is considered “historic” by advocacy and medical groups such as Free the Pill and the American College of Obstetricians and Gynecologists, which have been lobbying 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 contraception with abortion.
March for Life, the organization behind an annual event in which thousands of pro-life activists descend on Washington DC for an anti-abortion demonstration, has argued for years that hormonal contraception caused abortion.
They call birth control, vaginal rings, and other forms of birth control “abortives.”
In the eyes of this group, the use of any contraceptive method that prevents the implantation of a fertilized egg in the uterus is tantamount to abortion.
Triona Schmelter, executive vice president and president of Consumer Self-Care Americas at Perrigo, said, “From an online perspective, it should be available to order almost immediately.”
As for stores, she said that “it will take a few weeks for it to come through the distribution pipeline, where we ship to the retailers’ distribution facilities and then they ship to their stores.”
Opill has been safe to use for about fifty years, but the US is an outlier when it comes to making the pills available without a doctor’s prescription.
Unlike combination pills, Opill does not contain estrogen, which increases the risk of blood clotting tenfold; the 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’s announced they will commercialize the abortion pill mifepristone
Progestin-only pills do not prevent ovulation to the same extent as combination pills. Therefore, their effectiveness is slightly lower. Opill has been shown to prevent pregnancy from ever occurring in 98 percent of cases.
The FDA’s Nonprescription Drugs Advisory Committee and the Reproductive and Urologic Drugs Advisory Committee, which met in May to discuss the approval and voted unanimously in favor, had two primary concerns about designating Opill for over-the-counter drugs.
The primary concern was obesity, which has become increasingly common over time. Currently, about four in ten Americans are medically considered overweight. In 1960 this was closer to 13 percent.
Research has shown that obese women who use oral contraceptives have an increased risk of blood clots, although that link is weaker when it comes to progestin-only pills.
Agency officials said: ‘Although the original clinical trials of norgestrel tablets (minipill) did 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 trials were conducted in more than 50 countries. years ago.’
“The extent to which (Opill’s) efficacy is reduced in overweight or obese individuals (who now represent approximately 60% of the US population of reproductive age…) remains unknown,” she added.
FDA officials were also concerned that making the pill available without a prescription would eliminate the ability for doctors to explain to patients the importance of taking the progestin-only pill within the same three-hour window every day, making it risk of missed doses or by mistake increases. doubling the doses.
HRA Pharma addressed this concern in an extensive study called ACCESS, which simulated an OTC environment to see if people could screen themselves and use Opill appropriately.
The study showed that 93 percent of people who took the minipill did so every day as scheduled.
Ms. Schmelter noted that once Opill becomes available, customers should be able to find it in the family planning section.
Walgreen’s and CVS have both announced they will offer Opill.
CVS spokesman Matt Blanchette said CNN: “Opill will be available at CVS.com and through the CVS Pharmacy app in late March.”
“By early April, more than 7,500 CVS Pharmacy stores will offer Opill and for added privacy and convenience, customers can choose same-day delivery or buy online and pick up in store.”
Perrigo’s announcement comes days after CVS and Walgreen’s, two of America’s largest pharmacies, said they will start selling the abortion pill mifepristone in several states this month.