A Pharmaceutical Company Is Seeking FDA Permission To Sell an Over-the-Counter Birth Control Pill

As common as the birth control pill is, there are still barriers that prevent some people in the U.S. from getting it. Now, for the first time, a pharmaceutical company is asking the Food and Drug Administration (FDA) to allow birth control pills to be sold over-the-counter. The Paris-based company, HRA Pharma, is seeking to introduce their popular brand Opill to American patients and make it as easy as possible to buy.

In 2022, The United States is one of few countries that have not allowed birth control pills to be regulated over-the-counter. This barrier was put in place by the FDA to ensure that patients who use the product can be screened for risks of blood clots and to make sure they understand how to use the pills safely. But in the UK, Asia, Europe, and other places, Opill and medication birth control pills similar to it, are seen as no riskier to take than fever reducers or simple pain relievers such as ibuprofen.

But Opill is a bit different from other birth control pills currently on the American market. Typically, birth control pills include progestin, the hormone that blocks fertilization, and estrogen, which helps to make a period lighter. However, since estrogen can contribute to the risk of blood clots, the FDA has deemed them fit for prescription-only status. Opill, however, does not include estrogen in its recipe.

Before HRA Pharma applied to the FDA to make Opill available over-the-counter, they spent seven years preparing. This is important to note since the timing of this application has many wondering if the company was spurred to action based on the overturning of Roe v. Wade, but they insist this has been a long time coming.

HRA Pharma's studies included following 1,000 study participants who took the pills for six months. They also conducted all the required FDA studies that can demonstrate safety and effectiveness.

"For a product that has been available for the last 50 years, that has been used safely by millions of women, we thought it was time to make it more available," Frederique Welgryn, HRA's chief strategy officer, told CBS News.

In 2020, the FDA found itself under political pressure after it expanded access to medical abortion pills by allowing them to be mailed through the United States Postal Service. And in 2006, the FDA faced backlash after it allowed the contraceptive Plan B to be sold over-the-counter without a prescription.

The FDA considers safety above all else when it comes to allowing any drug to be sold over the counter. The companies applying for such a thing must be able to demonstrate that consumers can clearly understand the directions for use, the risks in taking it, and that they are able to take the drug safely and without consequence.

That said, blood clots are very serious and can be lethal, which is why birth control pills, particularly brands currently on the market that include estrogen, are regulated to be prescription only. But before the idea of a blood clot scares anyone, the FDA points out in its own data that there is a higher risk for pregnant and postpartum people of forming a blood clot than a person taking birth control pills.

According to the FDA, for every 10,000 people, these are the numbers of people who developed a blood clot:

• Non-pregnant, non-COC user (combination oral contraceptive or birth control pills) ranges from 1 to 5 people.
• COC-users range from 3 to 9 people.
• Pregnancy ranges from 5 to 20 people.
• Postpartum ranges from 40 to 65 people.

"What I definitely see is a misunderstanding of the dangers of these pills. It is much safer to take the pill than to be pregnant," Dr. Maura Quinlan, a Northwestern University physician and member of the American College of Obstetricians and Gynecologists, told CBS News.

The typical timeline for the FDA to respond to applications is around ten months, which means that if HRA Pharma is approved, birth control pills could potentially begin appearing on store shelves as early as mid-2023.