Drug company asks FDA for approval for OTC birth control pills

HRA Pharma said it hopes that regulatory approval comes early next year.

July 11, 2022, 6:36 PM

A French-based pharmaceutical company announced Monday that it has asked the Food and Drug Administration to sell over-the-counter birth control pills in the U.S., making it the first business to file an official application.

Perrigo's HRA Pharma said it hopes that regulatory approval comes early next year.

"This historic application marks a groundbreaking moment in contraceptive access and reproductive equity," Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma, said in a statement.

"More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant," Welgryn said. "Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers."

Currently, hormone-based birth control pills require a doctor's prescription because of health concerns such as blood clotting in some women. But most doctors say the risk is minimal for the vast majority of the population and note that pregnancy can carry its own significant health risks.

Reproductive rights advocates say an over-the-counter pill would make it easier for women without access to health care to obtain contraceptives.

PHOTO: Michigan Governor Gretchen Whitmer speaks during a news conference in Lansing, Mich., Jan. 25, 2022.
Michigan Governor Gretchen Whitmer speaks during a news conference in Lansing, Mich., Jan. 25, 2022.
Paul Sancya/AP, FILE

"In the wake of the overturn of Roe v. Wade, we must pull out all the stops to make it easier and more affordable for everyone to secure contraception and take bold steps to protect women by ensuring that health -- not politics -- guides medical decisions," said Michigan Gov. Gretchen Whitmer, a Democrat.

The FDA did not immediately respond to ABC News' request for comment.

According to the Centers for Disease Control and Prevention, 65.3% of women aged 15 to 49 use contraception, with 14% taking pills.

The move comes weeks after the U.S. Supreme Court overturned Roe v. Wade, which granted people a constitutional right to an abortion for nearly 50 years.

Senate Republican Leader Mitch McConnell had said it was a relief, calling Roe v. Wade "one of the most egregious legal and moral mistakes of the 20th century."

PHOTO: Senate Minority Leader Mitch McConnell holds a press conference at the U.S. Capitol in Washington, D.C., June 22, 2022.
Senate Minority Leader Mitch McConnell holds a press conference at the U.S. Capitol in Washington, D.C., June 22, 2022.
Elizabeth Frantz/Reuters

The fallout from Roe's reversal has many people worried that the Supreme Court will overturn other constitutionally protected rights.

In his concurrent opinion, Supreme Court Justice Clarence Thomas called for the court to reconsider other cases, including Griswold v. Connecticut, which gave married couples the right to use contraception.

He also asked the court to reconsider Lawrence v. Texas, which protects the right to same-sex romantic relationships; and Obergefell v. Hodges, which establishes the right to same-sex marriage.

"In future cases, we should reconsider all of this Court's substantive due process precedents, including Griswold, Lawrence, and Obergefell. Because any substantive due process decision is "demonstrably erroneous," we have a duty to "correct the error" established in those precedents," Thomas wrote.

ABC News' Kiara Alfonseca contributed to this report.

Related Topics

ABC News Live

ABC News Live

24/7 coverage of breaking news and live events