The U.S. Food and Drug Administration approved norgestrel — the first daily oral contraceptive to be sold over the counter without a prescription in the U.S. — July 13. Norgestrel, sold under the name Opill, is a progestin-only pill manufactured by HRA Pharma and will ultimately be available for consumers to purchase without a prescription at convenience stores, drug stores and online.
HRA Pharma’s parent company, Perrigo Company plc., said it expects Opill to be available at in store and online retailers in the U.S. in early 2024.
The pill’s nonprescription approval comes 50 years after the drug was originally approved for prescription use in 1973. However, the drug has not been available in the U.S. since 2005 when norgestrel’s manufacturer decided to stop selling the drug due to competition from other birth control pill brands, according to the FDA.
[Related: FDA fully approves first drug to slow down the effects of Alzheimer's disease]
In a statement released Thursday, Director of the FDA’s Center for Drug Evaluation and Research Patrizia Cavazzoni said Opill is expected to be more effective at preventing unintended pregnancy than other nonprescription contraceptive methods, such as using condoms or spermicides.
In a press release, the FDA stated approximately half of the 6.1 million pregnancies in the U.S. each year are unintended. The FDA believes non-prescription availability to Opill may help reduce this rate of unintended pregnancies. According to the Centers for Disease Control and Prevention, unintended pregnancies can increase the risk of poor maternal and infant outcomes.
Perrigo Company plc’s Global Vice President for Women’s Health Frederique Welgryn said in a press release the manufacturing company is aiming to make Opill affordable to women of all ages. According to a 2022 KFF Women’s Health Survey of more than 5,000 women, 77% of reproductive age respondents favored making birth control pills available without a prescription if research showed the pill was safe and effective.
[Related: 'How am I going to save my baby's life?': families grapple with ban on gender-affirming care for minors]
According to an FDA press release, taking Opill can have side effects including nausea, dizziness, irregular bleeding, increased appetite, abdominal pain, bloating and cramps. Norgestrel also does not prevent pregnancy after unprotected sex.
Additionally, the FDA states Opill should not be taken by those who have or ever had breast cancer, are already pregnant or think they may be pregnant, or are already taking another form of birth control.
To gain approval for the drug, the FDA required HRA Pharma, which was recently acquired by Perrigo Company plc., to prove consumers could use Opill safely and understand the information and instructions on the drugs facts label.
According to the FDA, the price and availability of Opill will be determined by the drug manufacturer. HRA Pharma has not yet announced how much the pill will cost consumers.
[Related: Indiana Supreme Court approves near-total abortion ban]
Opill’s approval also comes after Indiana Gov. Eric Holcomb signed House Bill 1568 which allows pharmacists — not just physicians — to prescribe some hormonal contraceptives to women in the state. Under the new law, which went into effect July 1, pharmacists can prescribe birth control for up to six months. The law also prohibits pharmacists from prescribing a contraceptive to a woman after 12 months unless the women has been seen by a physician, advanced practice registered nurse or physician assistant. Pharmacists can also decline to prescribe contraceptives on ethical, moral or religious grounds.
