FDA Advisors Express Concerns Over Proposed OTC Birth Control Pill

FDA Advisors Express Concerns Over Proposed OTC Birth Control Pill

Advisory committee meetings are set to take place next week to discuss HRA Pharma’s proposed first-in-class prescription-to-nonprescription switch of daily 0.075 mg norgestrel tablets (Opill) for over-the-counter (OTC) use. HRA Pharma submitted three consumer behavior studies, one of which was the ACCESS study, which raised concerns among FDA staff.

Staff Concerns

FDA staff questioned the safety and efficacy of the OTC birth control pill, stating that it is contingent on whether a consumer can appropriately self-select and adhere closely to the directions for use, or correctly choose not to use the product. They also expressed concerns regarding comprehension of labeling contraindications and potential drug interactions.

For instance, labeling comprehension studies performed by the applicant found that comprehension of contraindications for women with breast cancer or a history of the malignancy “did not approach the prespecified target threshold,” with some participants failing to correctly deselect. The FDA explained that the use of norgestrel in these consumers may stimulate the growth of progesterone-receptor positive tumor cells and can increase the risk of recurrence.

The FDA also expressed concerns over potential drug interactions, stating that using medications that interact with norgestrel can result in decreased efficacy of norgestrel or the other medication or both. The consequences of this can be severe, potentially resulting in unintended pregnancy or seizures in an individual with a seizure disorder.

Consumer Behavior Studies

HRA Pharma submitted three consumer behavior studies, one of which was the ACCESS study. The study raised concerns among FDA staff as a third of participants reported taking more tablets than dispensed, which may “call into question the reliability of all of the actual use data.” Additionally, half of women with abnormal bleeding had not discussed it with their healthcare provider yet identified themselves as eligible for the medicine.

FDA advisory committee members will be tasked with discussing whether consumers will correctly and consistently take the pill without guidance from a healthcare professional. They will assess the general population, as well as adolescents, people with limited literacy, and people using concomitant products that could interact with or reduce the efficacy of norgestrel tablets.

If the FDA approves Opill, it would be the first OTC birth control pill in the market. However, FDA staff’s concerns over consumer behavior and comprehension may lead to a rejection of the proposed switch.


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