FDA Approves First Nonprescription Daily Birth Control Pill

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The approval of norgestrel tablets (Opill) could open the door to other prescription-to-OTC contraceptive switches, although that remains to be seen as other pharmaceutical companies weigh their options.

The FDA has approved norgestrel tablets (Opill, Perrigo) as a nonprescription contraceptive, making it the first daily oral contraceptive approved for use in the United States without a prescription.

The approval gives patients a new option to purchase an oral contraceptive at drug stores, convenience stores, and grocery stores, as well as online. The timeline for availability and price will be determined by Perrigo and have not yet been announced, and other approved formulations and dosages of other oral contraceptives remain prescription-only.

The approval could open the door to other prescription-to-OTC contraceptive switches, although that remains to be seen as other pharmaceutical companies weigh their options, according to Ron Lanton III, Esq., partner at Lanton Law.

“I definitely think that that’s what the goal is, to increase access,” Lanton said in an interview with Pharmacy Times. “So, if you’ve had one, you’re likely going to have other sponsors come in and say, ‘Well, maybe we should be OTC as well.’ But I think that’s an FDA decision.”

The availability of Opill without a prescription may reduce barriers for patients by allowing individuals to obtain the contraceptive without first seeing a health care provider. Nearly half of the 6.1 million pregnancies each year in the United States are unintended, according to the FDA, and unintended pregnancies have been associated with negative maternal and perinatal outcomes. These can include reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental, and child health outcomes.

The efficacy of norgestrel was established with the original approval for prescription use in 1973. For approval in the nonprescription setting, the FDA requires that the applicant demonstrates that the product can be safely and effectively used by consumers, relying only on the nonprescription drug labeling without any assistance from a health care professional. Studies showed that consumer understanding of the information on the Opill Drug Facts label was high overall and that a high proportion of consumers understood the instructions.

Opill should be taken at the same time every day, which is important for the effectiveness of the drug. Some medications can interact with Opill, resulting in decreased efficacy of either Opill or the other medication. These medications include carbamazepine, barbiturates, rifampin, efavirenz, bosentan, and herbal medications containing St. John’s Wort.

The most common adverse events with Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, or bloating.The OTC approval comes amid significant state-level confusion regarding access to the medicated abortion pill mifepristone. Although that medication is notably different than a contraceptive, Lanton told Pharmacy Times that this ongoing issue may cause more concern for pharmacists worried about legal or liability issues.

“I can see where there might be heightened anxiety about this because different states have different roles and, you know, it just depends on where you’re at,” Lanton said in an interview with Pharmacy Times. “I think that if I were a pharmacist right now, I would really just keep paying attention to the Board of Pharmacy, just to make sure to see if there are any relevant rules.”

With its established efficacy and safety, the OTC approval of Opill offers a crucial new option for patients amid those growing restrictions on access to abortion care.

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said Patrizia Cavazzoni, MD, director of the FDA Center for Drug Evaluation and Research, in a press release. “When used as directly, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”

Reference

FDA Approves First Nonprescription Daily Oral Contraceptive. News release. FDA. July 13, 2023. Accessed July 13, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive

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