US approves first over-the-counter birth control pill

In Germany, birth control pills require a prescription. This has been the case in the USA up until now. Now the competent authority approved the first over-the-counter pill. It aims to make it easier for American women to access effective contraception.

For the first time, the US Food and Drug Administration (FDA) has approved a birth control pill that can be bought without a doctor’s prescription. It should be available in drugstores, supermarkets and online shops from the beginning of 2024. There is also no need to consult a doctor before purchasing.

The pill, called Opill, comes from Perrigo, a company based in Ireland. According to the FDA, studies showed that the information and instructions on the Opill package insert were clearly understandable for a large proportion of women – a prerequisite for taking the birth control pill properly and selling it over the counter.

Opill contains progestin but no estrogen

In the United States, hormonal birth control pills have long been the most common form of contraception. Until now, prescriptions have always been necessary. Opill contains a progestin but no estrogen. It is one of the low-dose, purely progestin-containing contraceptives, also known as the “mini pill”. According to the FDA, it is important for the effectiveness of Opill that it is taken every day at the same time of the day. The authority listed the most common side effects as headache, dizziness, nausea, increased appetite, abdominal pain, cramps and flatulence.

“Today’s approval makes, for the first time, an over-the-counter, daily oral contraceptive an available option for millions of people in the United States,” said Patrizia Cavazzoni, FDA representative. When used correctly, the birth control pill is “safe” and “more effective than currently available over-the-counter birth control methods.” The agency explained that almost half of the approximately 6.1 million annual pregnancies in the United States are unwanted. Access to an over-the-counter contraceptive pill can help reduce the number of unwanted pregnancies with potentially negative effects.

Currently high hurdles for parts of the population

Generally, the cost of over-the-counter medications in the United States is not covered by health insurance. However, parts of the US population are currently finding it difficult to get a prescription and pick up the drug. The background is both the cost of a doctor’s visit and the need to take time off for this purpose or to organize childcare.

The pill from the pharmaceutical company Perrigo has been approved in the USA since 1973 – but so far only on prescription. This is now changing with FDA approval.

Contraceptive pills are already available without a prescription in various countries around the world – including Brazil, Greece, Mexico and Portugal. In many other countries – including Germany – a prescription from a doctor is required. The background are individual risk factors of the patients, which must be taken into account when choosing a suitable contraceptive pill. In Great Britain, a progestin-only pill was approved in 2021 without a prescription – but professional advice from a pharmacist is required there.