FDA approves nonprescription oral contraceptive
Nonprescription availability may improve access, the FDA said, by allowing people to obtain it without first having to see a provider.
Photo: Jeff Lagasse/Healthcare Finance News
The U.S. Food and Drug Administration has drawn praise from Health and Human Services Secretary Xavier Becerra for its approval of Opill, the first daily oral contraceptive approved for use in the U.S. without a prescription.
The approval means the progestin-only oral contraceptive pill will be available without a prescription at drug stores, convenience stores and grocery stores, as well as online.
The timeline for availability and price of the product will be determined by the manufacturer. Other approved formulations and dosages of other oral contraceptives will remain available by prescription only, the FDA said.
Nonprescription availability of Opill may reduce barriers to access, the agency said, by allowing people to obtain it without first having to see a healthcare provider.
Praising the move, Becerra called it an "important step."
"The FDA's approval of the first daily over-the-counter oral contraceptive will provide millions with access to safe and effective birth control without a prescription," he said. "For women, this approval will lower long-standing barriers to the healthcare they need. The professionals at the FDA deserve our gratitude for continuing to foster critical innovation for consumers while achieving the highest standards for safety and scientific review."
WHAT'S THE IMPACT?
According to the FDA, almost half of the 6.1 million pregnancies in the U.S. each year are unintended. Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes.
Availability of Opill may help reduce the number of unintended pregnancies and their potential negative impacts, the FDA said.
The contraceptive efficacy of norgestrel was established with the original approval for prescription use in 1973. HRA Pharma applied to switch norgestrel from a prescription to an over-the-counter product. For approval of a product for use in the nonprescription setting, the FDA requires the applicant to demonstrate that the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a healthcare professional.
The FDA cited studies showing a high level of consumer understanding on Opill's drug facts label, and that a high percentage of consumers understood the label instructions. This level of comprehension supports the case for approving it as an over-the-counter product.
Opill should be taken at the same time every day, and adherence to daily use at the same time of day is important for its effectiveness. Using medications that interact with Opill can result in the decreased efficacy of Opill, the other medication, or both, potentially resulting in unintended pregnancy.
The most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps and bloating.
THE LARGER TREND
Last year, HHS said it was committed to supporting safe pregnancies and childbirth, eliminating pregnancy-related health disparities, and improving health outcomes for parents and infants across the country.
These investments are part of the implementation of the White House Blueprint for Addressing the Maternal Health Crisis released in June.
In November 2021, HHS announced that more than 200 hospitals signed on to a new program, Perinatal Improvement Collaborative, a contract with Premier. The program evaluates how pregnancy affects overall population health by linking inpatient data of newborns to their mothers.
Twitter: @JELagasse
Email the writer: Jeff.Lagasse@himssmedia.com
