The U.S. Food and Drug Administration is studying the possibility of approving the sale of over-the-counter birth control pills, a method widely available in more than 100 countries for years. An advisory committee will meet this week to review the application from HRA Pharma, the French drugmaker owned by Perrigo, in what would be the last step before making a decision.

The company doesn't expect a final determination to be made before summer. If given the green light, Opill, the contraceptive method that has been marketed for decades, could be purchased in the US without having to see a doctor before, directly in a pharmacy or online.

From HRA Pharma argue that the pill would be a reliable and very effective option for almost 15 million American women, the segment of the population of reproductive age in the first world power. They argue that it is a much more effective way than female condoms to prevent an unwanted pregnancy and a drug that has been used for 50 years safely by millions of women around the world.

"Women's needs are nuanced, and it's about time their health choices reflected that," Frederique Welgryn, global vice president of the Women's Health initiative at HRA Pharma, said in a statement. "We are reimagining a new world where people are empowered to determine their own sexual health path and access the solutions they want."

However, there are doubts within the FDA about the reliability of HRA Pharma's studies and the fear that some consumers do not clearly understand product labeling. The advisory panel is expected to deliver its verdict on Wednesday and the government agency is expected to rule in a few weeks. Of course, the contraceptive method would not be available immediately or at the speed with which the covid vaccine arrived, approved urgently by the global crisis.

Oral contraceptives entered the U.S. market more than 60 years ago and have required a prescription ever since. The green light from the FDA came in 1973, just the year the Supreme Court legitimized abortion rights at the federal level following the Roe v. Wade decision.

HRA Pharma filed the petition with the FDA two weeks after the Supreme Court repealed that right 49 years later, which immediately triggered the ban on abortion in several states of the country and the requests of activists to expand access to contraceptive methods to citizens. The political battle continues and is expected to be a major factor ahead of the 2024 presidential elections.


  • Abortion
  • United States

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