Not exactly over-the-counter, actually pharmacist prescribed birth control pills:

https://www.bridgemi.com/michigan-health-watch/over-counter-birth-control-hitting-shelves-thanks-michigan-firm

Over-the-counter birth control hitting shelves, thanks to Michigan firm

• The FDA decided last year that a longtime birth control pill was safe enough to gain over-the-counter status.
• The drug, Opill, is the product of a Grand Rapids-based company which has headquarters in Ireland, too.
• The pill began shipping Monday at a cost of $20 a month, or $50 for a three-month supply.

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By Robin Erb - March 4, 2024

The first over-the-counter daily birth control pill began shipping to pharmacies Monday, dramatically boosting convenience and access among oral contraceptives, especially for low-income women, those living in rural areas and those without easy access to transportation or child care.

On Monday, Opill — which is offered in a 28-day blister pack and is 98% effective against unplanned pregnancies when taken as directed — became available for the first time nationally.

It is the product of drugmaker Perrigo, which is based both in Grand Rapids and Ireland.

The drug is being manufactured in Ireland, and its active ingredient, norgestrel, is being manufactured in Germany.

After months of anticipation by medical groups and consumer groups, the company announced the first, long-awaited shipments Monday morning.

“It’s revolutionary in terms of having women take control of their reproductive choices,” said Dr. Ann Gillett-Elrington, a staff physician and board-certified obstetrician at Western Wayne Family Health Centers.

The suggested retail price will be $20 for a one-month supply, $50 for a three-month supply and $90 for a six-month supply.

The relatively low cost is good news, especially for the uninsured or without regular medical care, she said.

“Appointments — sometimes they're far in between. People can get pregnant in the interval,” she said. “They also have to take time off from work (for an appointment) and they might have to make child arrangements.” 

Given the cost of those things or an unplanned pregnancy, the pill “is very cost-effective,” she said.

The pill will be available at major retail pharmacies, including Walgreens and CVS, and through Amazon, said Perrigo’s chief commercial officer, Sara Young, who called the pill “groundbreaking.” 

The French drugmaker HRA Pharma had begun seeking FDA approval for its over-the-counter product when Perrigo purchased the company in a sale completed in 2022.

Opill will also be sold online directly to consumers from opill.com on March 18, she said.

Long awaited

The U.S. Food and Drug Administration switched Opill, a progestin-only tablet, to an over-the-counter drug in July. Because it doesn’t contain the hormone estrogen, it may have few side effects. Most common side effects are irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating, according to the FDA’s July announcement.

The drug had originally been approved in 1973. In making its decision last year, the FDA made it clear that the pill was safe and effective enough that Americans could decide on their own — with consulting with a doctor — whether Opill is appropriate for them.

That’s “obviously a very important step forward regarding convenience and access,” said Dr. Mark Fendrick, an internal medicine doctor and director of the Center for Value-Based Insurance Design at the University of Michigan.

About 26 million Americans are uninsured, according to the U.S. Census, making it difficult or too expensive to get regular medical care, he said.

Family planning, including options for oral contraception, is “a very effective, equitable and important public health and population health measure,” he said, so Opill is a “great step forward for access.”

Moreover, limitations or bans on abortion in some states make pregnancy prevention even more critical. 

For its part, Right to Life of Michigan, aligning with national leaders of Right to Life, takes no position on products that prevent an egg’s fertilization, legislative director Genevieve Marnon, told Bridge Michigan, Monday.

Still unknown is whether insurers, including the state’s Medicaid program, will cover the costs of the pill.

The pill likely will show up at local pharmacies later this month, said Farah Jalloul, state emergency preparedness coordinator at the Michigan Pharmacists Association. And pharmacies can decide whether they will carry the pill, she noted, though she added that most undoubtedly will do so. 

When it hits the shelves, it will be available to consumers of any age — a concern for some who worry about adolescents or some adults who might be unable to follow directions or understand contraindications. 

Among those who should not take Opill are women with a history of breast cancer. People who have any other  form of cancer should consult their doctor before taking Opill. And Opill is not for use as emergency contraception nor does it prevent sexually transmitted infections. 

Ideally, said Gillett-Elrington at Western Wayne Family Health Centers, a young person or an adult with questions will talk with a trusted medical professional before taking Opill, though there are no guarantees, she acknowledged.

The drug works mainly by thickening a person’s cervical mucus, thereby blocking sperm from reaching the egg. Opill also may prevent an egg from implanting or altogether block its release from the ovaries. But a pill from the 28-day blister pack must be taken every day.

More than one in three women using oral contraceptives (36%) had missed taking doses because they were unable to get their next supply, according to a 2022 KFF Women’s Health Survey. 

Medical groups, including the American Medical Association, had urged the FDA to approve over-the-counter daily contraception. And the American College of Obstetricians and Gynecologists Monday lauded the release, and released guidelines for clinicians.

ACOG President Dr. Verda J. Hicks, called Opill a safe drug for patients of all ages, including adolescents. 

It’s a “key component of reproductive health care” in a country where there are “increasing healthcare deserts … where people do not have access to gynecologic care,” she said in a prepared statement.

Despite some initial concerns that consumers might not be able to understand how to take the pills or why some patients should not take the pills, ACOG doctors “trust our patients to determine if this OTC method is best for them.”

Perrigo executed a corporate tax inversion to Ireland eleven years ago to avoid U.S. corporate taxes.  It was 'acquired' by Irish-based Elan Corporation for $ 8.6 billion.  The combined company is now known as Perrigo Company plc.