After a petition from a French pharmaceutical company HRA Pharma, the FDA will consider allowing the over-the-counter sale of birth control pills to American consumers.
Since they were introduced in the 1960s, birth control pills have always required a prescription from a doctor. However, if approved by the FDA, this could soon change.
HRA Pharma produces and markets hormonal contraceptives, and birth control pills are one of its most commonly used products.
Some physicians still support needing a prescription for birth control to provide medical advice and screen for problems that can increase the risk of side effects, such as blood clots.
However, the company says it has conducted extensive safety research to back up its claim, and that women have enough information and experience with the contraceptive pill to make an informed decision about risks and benefits without consulting a doctor.
“For a product that has been available for the last 50 years, that has been used safely by millions of women, we thought it was time to make it more available,” Frederique Welgryn, HRA’s chief strategy officer, told the Associated Press.
Will the overturning of Roe vs. Wade affect the outcome?
The application to change the FDA regulations on birth control has come just days after the US Supreme Court overturned the landmark 1973 ruling, Roe vs. Wade, which legalized abortion.
But, the drug maker says that the timing is not related and that its application is not linked to the high court ruling.
In fact, Congress had been under pressure for some time to relax the regulations and allow women better access to birth control before the court decision.
In March, the House Pro-choice Caucus sent a letter to FDA Commissioner Dr. Robert Califf, requesting that birth control is made more accessible to American consumers.
The letter said: “This is a critical issue for reproductive health, rights, and justice. We ask for your ongoing commitment to advance public health and follow the science and data in all decisions, including the timely review of the oral contraception applications.”
An FDA decision is not expected straight away, but if approved, the company’s pill, Opill, will be available over the counter. Other manufacturers would need to file their own applications.