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The FDA has approved an over-the-counter birth control pill. What does it mean?

Northwestern Medicine experts share their viewpoints and explain what is at stake after FDA approval
The U.S. FDA has approved the Opill tablet to prevent pregnancy, paving the way for consumers to purchase the medicine online or in grocery and convenience stores.

The U.S. Food and Drug Administration (FDA) has approved the Opill (norgestrel) tablet to prevent pregnancy. It is the first daily oral contraceptive approved for use in the U.S. without a prescription. The approval paves the way for consumers to purchase the medicine online or in stores.

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The need for easy access to reliable contraception has never been greater.”

Dr. Lauren Streicher

Two women’s reproductive health experts from Northwestern Medicine — Dr. Lauren Streicher and Dr. Melissa Simon — spoke recently with Northwestern Now to explain the implications of the FDA approval.

“With new restrictions making access to abortion for unintended pregnancies non-existent in much of the country, the need for easy access to reliable contraception has never been greater,” said Streicher, a clinical professor of obstetrics and gynecology at Northwestern University Feinberg School of Medicine.

“This is a monumental decision to finally have over-the-counter approval for an oral contraceptive,” said Simon, vice chair for research in the department of obstetrics and gynecology and professor of obstetrics and gynecology, preventive medicine and medical social sciences at Feinberg and a Northwestern Medicine physician. “The FDA should be applauded for aligning contraceptive access with the science.”

What is at stake when it comes to contraception?

“Barriers to obtaining contraception, such as the prescription requirement, contribute to our nation’s sky-high unintentional pregnancy rate,” Streicher said. “Getting a prescription is a huge burden to many women who have no regular physician, no insurance and a job that doesn’t allow the luxury of taking an afternoon off to go to see a doctor. The college student without a gynecologist (and without a car) doesn’t have it any easier. Not to mention, many insurance companies only release one month of pills at a time. It’s easy to understand how a prescription can lapse.” 

How does U.S. access compare globally?

“Over-the-counter birth control is available in more than 100 countries,” Simon said. “So, the U.S. is substantially behind in availing safe, effective ways, such as this oral contraceptive pill, to individuals who are trying to avoid pregnancy and plan their families.”

Are there associated medical risks?

“Opponents express concern that high-risk women are likely to take birth control pills, which will lead to an increase in serious side effects such as blood clots and heart attacks,” Streicher said. “The average woman is more than capable of self-screening and determining if taking pills would be dangerous or inappropriate. No woman wants to have a medical complication. If someone has a medical issue such that she’s not a candidate for hormonal contraception, it is not dissimilar to a man with kidney failure who is informed that over-the-counter painkillers are not safe.”

What other factors will influence who gets this contraception?

“The next important decision is going to be what price these pills will cost,” Simon said. “This decision on cost is critical to ensuring equitable access for all persons who will want to use and will benefit from this pill. If the price point is set too high, this will prohibit those from lower socioeconomic backgrounds from access. This is especially important in states that have near total or total abortion bans — where access to and use of contraception to prevent unintended pregnancy is critical.”