USA —The US Food and Drug Administration (FDA) has given the green light to Perrigo’s Opill (norgestrel) for over-the-counter (OTC) use, marking a significant milestone as the first hormonal oral contraceptive available without a prescription in the United States.
The FDA’s Center for Drug Evaluation and Research Director, Patrizia Cavazzoni, emphasized the safety and effectiveness of daily oral contraception when used as directed, highlighting its potential to outperform existing non-prescription contraceptive methods in preventing unintended pregnancies.
According to the FDA, approximately half of the 6.1 million pregnancies in the US each year are unplanned.
The approval of Opill for OTC use is anticipated to eliminate barriers to access and reduce the risk of unintended pregnancies, addressing a pressing public health concern.
Originally approved by the FDA for prescription use in 1973, Opill’s OTC approval followed a unanimous 17-0 vote by the advisory panel earlier this year, endorsing its recommendation despite concerns over certain data regarding its appropriate use.
These concerns revolved around ensuring that women with specific medical conditions that would typically exclude them from taking oral contraceptives, such as breast cancer and undiagnosed vaginal bleeding, would heed the warnings and refrain from using the product.
The National Catholic Bioethics Center and other groups have opposed making Opill available without prescription, saying physicians should be involved in health decisions, especially for teenagers, along with parental supervision, to avoid harm.
Additionally, FDA scientists raised questions about the ability of younger individuals and those with limited literacy to understand and adhere to the dosing instructions.
The agency also expressed skepticism about the potential exaggeration of positive results for the drug during research.
However, in its decision, the FDA affirmed that studies demonstrated high consumer comprehension of the information presented on Opill’s drug facts label.
The agency concluded that consumers’ understanding of the label instructions supported their ability to utilize the drug appropriately once it becomes available as an OTC product.
Common side effects associated with Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, and abdominal pain, as well as cramps or bloating.
It is important to note that Opill is not intended for use as emergency contraception and does not prevent pregnancy after unprotected intercourse.
The approval for Opill was granted to Laboratoire HRA Pharma, which Perrigo acquired last year for €1.8 billion (US$2 billion).
While the exact pricing details have not been disclosed, Frédérique Welgryn, Perrigo’s global vice president for women’s health, affirmed the company’s commitment to making the contraceptive accessible and affordable for individuals of all ages.
Furthermore, Perrigo intends to establish a consumer assistance program that will provide Opill at no cost to select women.
In a related development, President Joe Biden’s recent executive order may pave the way for the federal government to require insurance companies to cover OTC oral contraceptive medications, ensuring broader accessibility and affordability.
The FDA’s approval of Opill comes approximately three months after the Supreme Court’s ruling that blocked a controversial lower court order challenging access to the abortion drug mifepristone.
The lower court had sought to restrict access to mifepristone after a Texas district court judge invalidated the FDA’s approval of the drug, despite it being cleared for over two decades.
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