FDA clears first over-the-counter oral contraceptive
13 Jul 2023
Drug ApprovalAccelerated Approval
The FDA on Thursday approved Perrigo's Opill (norgestrel) for over-the-counter (OTC) use, making it the first hormonal oral contraceptive available in the US without a prescription. "When used as directed, daily oral contraception is safe and is expected to be more effective than currently available non-prescription contraceptive methods in preventing unintended pregnancy," stated Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research.
Roughly half the 6.1 million pregnancies in the US each year are unplanned, according to the FDA. It said the OTC approval "is expected to remove barriers to access and reduce the risk of unintended pregnancies."
The progestin-only drug was initially approved by the FDA for prescription use in 1973. The latest decision followed a 17-0 advisory panel vote earlier this year in favour of recommending Opill for approval despite questions over some data on its proper use. These included whether women with certain medical conditions that would ordinarily preclude them from taking oral contraceptives – such as those with breast cancer and undiagnosed vaginal bleeding – will follow the warnings and avoid the product.
FDA scientists also questioned whether younger people and people with limited literacy would be able to properly follow the dosing directions. In addition, agency staff suggested that researchers likely used methods that exaggerated positive results for the drug.
However, in its decision Thursday, the FDA said that studies showed that consumer understanding of information on Opill's drug facts label was "high overall and that a high proportion of consumers understood the label instructions, supporting their ability to properly use the drug when it is available as an [OTC] product." The most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating. The agency noted that Opill is not for use as emergency contraception and does not prevent pregnancy after unprotected sex.
Expected launch in early 2024
The approval of Opill was granted to Laboratoire HRA Pharma, which was acquired by Perrigo last year for €1.8 billion ($2 billion). The company said the contraceptive would be available for purchase by early 2024, but would not provide specifics about pricing. However, Frédérique Welgryn, Perrigo's global vice president for women's health, said the company was committed to making the drug "accessible and affordable to women and people of all ages," adding it would also set up a consumer assistance programme to provide Opill at no cost to some women.
Meanwhile, under a recent executive order by President Joe Biden, the federal government could soon take steps toward requiring insurers to cover OTC oral contraceptive medications.
The FDA approval comes nearly three months after the Supreme Court blocked a controversial lower court order challenging access to the abortion drug mifepristone. The lower court sought to restrict access to mifepristone, after a district court judge in Texas ruled to toss the FDA's approval of the drug, which had been cleared for more than 20 years.
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