For the first time, a drug company applied for US approval Monday to make its birth control pill available over the counter, weeks after the US Supreme Court overturned a federal right to abortion.
HRA Pharma, a subsidiary of Perrigo, said in a statement that it is seeking to move away from prescription for its product Opill, a progestin-only daily birth control pill – also known as the minipill or non-estrogen pill.
Over-the-counter (OTC) contraception has long been supported by major medical organizations to reduce barriers to contraceptive access.
The timing of the request – which comes amid a wave of state-level restrictions and abortion bans following the Supreme Court ruling – was “accidental,” according to an HRA spokeswoman, who said the company had compiled research for its request for the past seven years.
“This historic application marks a landmark moment for contraceptive access and reproductive equity in the United States,” said Frederique Welgryn, HRA Pharma’s chief strategic operations and innovation officer, in a statement.
“Moving a safe and effective prescription birth control pill to OTC will help even more women and people gain access to contraception without unnecessary barriers.”
Over-the-counter birth control is supported by major medical organizations, including the American College of Obstetricians and Gynecologists (ACOG), the American Medical Association, and the American Academy of Family Physicians.
It is also common practice in many countries, including Brazil, Greece, Mexico, Portugal, Russia, South Korea and Turkey.
In general, more affluent countries prefer more regulations and therefore only prescription birth control.
But according to ACOG, “data support that hormonal methods containing only progestin are generally safe and carry no or minimal risk of venous thromboembolism (VTE),” also known as blood clots.
“Several studies have shown that women are able to carry out self-tests to determine whether they are suitable for the use of hormonal contraceptives,” adds the organization in a statement on the subject published on its website.
A 2016 study found that nearly a third of US women who have attempted to obtain prescription contraceptives reported barriers to entry.
The application is now under review by the Food and Drug Administration, a process that would normally take about a year.
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