“The timing is random”
First over-the-counter contraceptive pill in the US before approval
07/12/2022, 8:58 am
At the end of June, the US Supreme Court abolished the nationwide right to abortion. Just a few weeks later, pharmaceutical company HRA Pharma submitted a “historic application” to the US Food and Drug Administration (FDA) for the first over-the-counter contraceptive pill. Coincidence says management.
The pharmaceutical company HRA Pharma wants to offer the first over-the-counter contraceptive pill in the USA. The French company has filed an application with the US Food and Drug Administration (FDA) for its estrogen-free mini-pill, Opill. The application provides that HRA Pharma may in future sell the contraceptive pill without a prescription.
The company expects FDA approval in the first half of 2023. A processing time of ten months is the rule for such applications, said HRA Pharma Manager Frederique Welgryn. He spoke of a “historic request”, but he did not want to confirm a connection with the most recent abortion ruling by the US Supreme Court. “The timing is random. We’ve been working on the application for seven years,” Welgryn said. Offering a safe and effective contraceptive pill without a prescription will give more women access to contraception “without unnecessary hurdles”.
The US Supreme Court abolished the nationwide right to abortion in late June. US President Joe Biden spoke of a “cruel judgment” that would set the United States back 150 years. Republican states in particular then banned abortion and closed abortion clinics.
Germany lags behind
Currently, only the morning-after pill is available in the US for emergencies. However, this must be taken within three days of unprotected sex. Iffath Abbasi Hoskins, President of the American Obstetricians and Gynecologists’ Association, spoke of HRA Pharma’s application as a positive development: “We know that contraception is not a solution to abortion. But the over-the-counter pill will help many people to plan their future.”
The highly controversial decision of the Supreme Court therefore led to considerations of how access to contraceptives could be improved in order to prevent unwanted pregnancies. In countries like Brazil, Greece, Mexico and Portugal, contraceptive pills are already available without a prescription. In Germany, for example, a prescription from a doctor is still required. Only the morning-after pill has been available in pharmacies without a prescription since 2015.