Drugmaker Aims to Offer First Nonprescription Birth-Control Pill in U.S.
The birth-control pill is among one of the most common methods of contraception used by women ages 15 to 49, according to the CDC.
Photo:
Rich Pedroncelli/Associated Press
A French pharmaceutical company is asking U.S. drug regulators to approve what it says would be the first over-the-counter birth-control pill in the U.S.
HRA Pharma, owned by drugmaker
Perrigo Co.
PRGO 2.07%
, said Monday it submitted an application to the U.S. Food and Drug Administration for over-the-counter use for Opill. The FDA approved the progestin-only daily birth control pill in 1973 for prescription use.
While birth control has been available in the U.S. for decades, the Supreme Court’s recent overturning of Roe v. Wade has focused attention on women’s health. Subsequently, abortion became largely illegal in many states.
“Moving a safe and effective prescription birth-control pill to [over the counter] will help even more women and people access contraception without facing unnecessary barriers,”
Frédérique Welgryn,
HRA’s chief strategic operations and innovation officer, said in prepared remarks.
The company expects the FDA to make a decision in about 10 months. Should it be approved, the pill could be available over the counter in 2023.
The FDA said Monday it doesn’t comment on pending applications.
HRA has been working on research for Opill to make it an over-the-counter drug in the U.S. for the past seven years. The specifics of the studies the company conducted will be made public once an advisory committee meeting is held for the drug.
About 65% of women ages 15 to 49 used contraception between 2015 and 2017, according to the Centers for Disease Control and Prevention. The pill was among one of the most common methods used, the CDC reported.
Write to Allison Prang at [email protected]
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
The birth-control pill is among one of the most common methods of contraception used by women ages 15 to 49, according to the CDC.
Photo:
Rich Pedroncelli/Associated Press
A French pharmaceutical company is asking U.S. drug regulators to approve what it says would be the first over-the-counter birth-control pill in the U.S.
HRA Pharma, owned by drugmaker
Perrigo Co.
PRGO 2.07%
, said Monday it submitted an application to the U.S. Food and Drug Administration for over-the-counter use for Opill. The FDA approved the progestin-only daily birth control pill in 1973 for prescription use.
While birth control has been available in the U.S. for decades, the Supreme Court’s recent overturning of Roe v. Wade has focused attention on women’s health. Subsequently, abortion became largely illegal in many states.
“Moving a safe and effective prescription birth-control pill to [over the counter] will help even more women and people access contraception without facing unnecessary barriers,”
Frédérique Welgryn,
HRA’s chief strategic operations and innovation officer, said in prepared remarks.
The company expects the FDA to make a decision in about 10 months. Should it be approved, the pill could be available over the counter in 2023.
The FDA said Monday it doesn’t comment on pending applications.
HRA has been working on research for Opill to make it an over-the-counter drug in the U.S. for the past seven years. The specifics of the studies the company conducted will be made public once an advisory committee meeting is held for the drug.
About 65% of women ages 15 to 49 used contraception between 2015 and 2017, according to the Centers for Disease Control and Prevention. The pill was among one of the most common methods used, the CDC reported.
Write to Allison Prang at [email protected]
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
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