By Top Class Actions  |  July 18, 2023

Category: Legal News
Over the counter store aisle, representing the FDA's clearance of over the counter birth control.
(Photo Credit: Mihai_Andritoiu/Shutterstock)

OTC birth control pill overview: 

  • Who: The US Food and Drug Administration (FDA) has approved the birth control pill Opill to be available non prescription and over-the-counter (OTC).  
  • Why: The FDA said OTC access to Opill could ‘reduce barriers to access’ for oral contraceptives and help prevent unintended pregnancy. 
  • Where: Nationwide.

The US Food and Drug Administration (FDA) has approved birth control pill Opill to be available over-the-counter (OTC), marking the first time a birth control pill will be accessible to Americans without a prescription. 

The agency said Thursday that the approval will allow consumers in the US to purchase oral contraceptive medicine “without a prescription at drug stores, convenience stores, and grocery stores, as well as online.” 

The timeline for the availability and the price of nonprescription Opill will be determined by the manufacturer, according to the FDA, which noted that all other oral contraceptives will remain available by prescription only. 

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a statement.  

FDA says over-the-counter Opill may ‘reduce barriers to access’ to oral contraceptives

The FDA said that, by making Opill available OTC, it could “reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to first see a health care provider.”

“When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy,” Cavazzoni said. 

Opill is expected to be available OTC starting early next year, reports CNN Health

The FDA has reportedly been under pressure by lawmakers and health care providers to make Opill available without a prescription, while President Joe Biden issued an executive order last month that focused on strengthening access to contraception. 

“The Executive Order directs the Secretaries of the Treasury, Labor, and HHS to consider new actions to improve access to affordable over-the-counter contraception, including emergency contraception,” the White House said. 

In May, the US Supreme Court chose to stay a Texas federal judge’s order to immediately ban access to the abortion pill mifepristone, allowing a case over the legality of the drug to play out. 

What are your thoughts on the FDA’s approval of an over-the-counter birth control pill? Let us know in the comments!


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