FDA Approves Opill as First Over-the-Counter Oral Contraceptive

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The U.S. Food and Drug Administration (FDA) has given its approval to norgestrel, making it the first daily oral contraceptive available over the counter without a prescription in the United States. The brand name for this progestin-only pill is Opill, manufactured by HRA Pharma. Opill will soon be accessible to consumers at convenience stores, drug stores, and online platforms without the need for a prescription. 

Perrigo Company plc, the parent company of HRA Pharma, has announced that Opill is expected to be available for purchase both in physical and online retail locations across the United States by early 2024. This nonprescription approval comes 50 years after norgestrel’s initial approval for prescription use in 1973. However, norgestrel has been unavailable in the U.S. since 2005 when the manufacturer decided to stop its sales due to competition from other brands of birth control pills, as confirmed by the FDA. 

According to the FDA, Opill is expected to be more effective in preventing unintended pregnancies compared to other nonprescription contraceptive methods like condoms or spermicides. Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research, emphasized the significance of this efficacy in a statement released on Thursday. 

A statement from the FDA highlighted that approximately half of the 6.1 million pregnancies occurring annually in the United States are unintended. The availability of Opill without a prescription is expected to contribute to a reduction in the rate of unintended pregnancies. The Centers for Disease Control and Prevention (CDC) has emphasized the risks associated with unintended pregnancies, which can have adverse outcomes for both mothers and infants. 

Frederique Welgryn, Global Vice President for Women’s Health at Perrigo Company plc, expressed the company’s commitment to making Opill affordable for women of all ages. Results from a 2022 KFF Women’s Health Survey involving over 5,000 women showed that 77% of reproductive-age respondents supported the availability of birth control pills without a prescription, provided research demonstrated their safety and effectiveness. While taking Opill may result in side effects such as nausea, dizziness, irregular bleeding, increased appetite, abdominal pain, bloating, and cramps, it does not provide protection against pregnancy after unprotected sex, according to the FDA.

The FDA also advises against using Opill for individuals with a history of breast cancer, those who are pregnant or suspect they may be pregnant, or those currently using another form of birth control. To obtain FDA approval for nonprescription use, HRA Pharma, which was recently acquired by Perrigo Company plc, had to demonstrate the safe use and understanding of Opill by consumers based on the information and instructions provided on the drug’s packaging. 

The price and availability of Opill will be determined by the drug manufacturer, as confirmed by the FDA. Perrigo Company plc has not yet disclosed the cost of the pill for consumers. The approval of Opill follows the recent enactment of House Bill 1568 by Indiana Governor Eric Holcomb, which allows pharmacists in the state to prescribe certain hormonal contraceptives to women.

This law expands access beyond physicians, enabling pharmacists to prescribe birth control for up to six months. However, after 12 months, women must seek consultation with a physician, advanced practice registered nurse, or physician assistant to continue receiving prescriptions. Pharmacists also have the right to decline prescribing contraceptives based on ethical, moral, or religious grounds. 

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