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FDA raises concerns about over-the-counter birth control pill

U.S. regulators will vote this week on whether the contraceptive Opill should be made widely available without a prescription.
FDA raises concerns about over-the-counter birth control pill
Posted at 12:59 PM, May 08, 2023

U.S. health regulators are considering whether a decades-old birth control pill should be made just as available as drugs like Tylenol and Ibuprofen.

The Food and Drug Administration is meeting this week to vote on whether the contraceptive Opill should be sold over-the-counter. The drug was first approved for use with a prescription in the U.S. 50 years ago. However, the FDA has raised concerns about the drugmaker Perrigo's application to have it moved from behind pharmacy counters.

In a 130-page document published Friday, the FDA cited problems with the company's data on its pill.

"Given that this product was approved in the 1970s and the paucity of data in today's target population of reproductive females in the United States, real-world effectiveness of this product in the United States remains ill-defined," the reviewers wrote. 

The agency also brought up Opill's labeling, saying younger teenagers may have difficulties understanding and correctly following its directions.

SEE MORE: Teen interest in birth control soars after Roe

"The study findings suggest that consumers do not adequately understand some of the necessary actions they need to take if they miss a tablet (such as the need for condoms or other barrier contraception) in order to avoid unintended pregnancy," reviewers wrote. 

Additionally, regulators questioned whether women with certain health conditions, such as breast cancer, would appropriately avoid the drug if it was made widely available.

"The results of this study appear to indicate that most females with current or previous breast cancer would appropriately deselect from taking norgestrel tablets," the agency said. "However, the results also show that there are some females with current or previous breast cancer who would — in the absence of a healthcare intermediary — incorrectly consider it "appropriate to use" for themselves."

 Hormonal contraceptive pills have long been one of the most common forms of birth control in the U.S., used by about 14% of women aged 15-49, according to the Centers for Disease Control and Prevention.   

While the most common use of oral contraceptives, like Opill, is to prevent pregnancy, many women also use them to manage other medical conditions — such as irregular menstruation, menstrual pain, and acne.  

Women's rights advocates have long called for oral contraceptives to be made available over-the-counter, as is the case in over 100 other countries, including the U.K.   

"In the months since the U.S. Supreme Court overturned Roe v. Wade, the dire state of reproductive health care in the United States—including access to contraceptive care—has moved to the forefront of public awareness," says the Center for American Progress, a public policy research and advocacy organization. "Expanding access to the full range of contraceptive options would not negate the need for abortion care services, but contraceptive care is a critical access point for ensuring that women can plan their pregnancies and for improving access to comprehensive reproductive health and rights."

Perrigo has touted its FDA submission as a "groundbreaking moment in contraceptive access." If regulators do approve the company's request, Opill would become the first contraceptive drug to be made available in the U.S. without the need for a doctor's prescription.


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