May 9, 2023
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Since girls and women who are prescribed birth control pills don’t always take them daily or at the same time every day, we do not think that is an issue of greater concern regarding OTC access to norgestrel, or OPill. Instead, we’ll focus on other types of imperfect use shown by the data.
We are concerned that if birth control pills become available OTC, pre-teens and young teens may use them inappropriately. We agree with FDA scientists that the ACCESS study data can’t be generalized for preteens, since only 3 participants were 12, and none were younger. Only 49 girls were younger than 15, and the Applicant did not collect information on sexual history at enrollment or sexual activity during the study so we don’t know if they abstained from sex or used barrier contraception when they initiated use of OPill, or after missing a pill.
Younger adolescents demonstrated especially low comprehension of certain key messages, like the need for additional non-hormonal contraception when starting the drug or after missing a dose. They also scored low in understanding of “Do not use as an emergency contraceptive.”
The ACCESS-UP study showed improbable dosing results for approximately 1/3 of participants, and 2/3 of those individuals reported over 20% more doses than their available supply. This calls into question the reliability of the actual use data.
We agree with the FDA that even with the “do not use” warning, we should be concerned about the lack of comprehension of women who have, or ever had, breast cancer. Although few breast cancer patients use birth control pills and most properly deselected from taking OPill, the data may not be generalizable to the real world since participants were not given the option of actually taking OPill and very few had limited literacy.
Similarly, in the ACCESS-SSP study, more than half of the participants who initially stated that they had unexplained vaginal bleeding and had not discussed it with their doctor, incorrectly decided that OPill would be appropriate for them to use. A quarter of participants in the ACCESS-UP study also reported that they had not spoken to a health care professional about their unexplained bleeding before or at any time during the study. Although they did not experience significant side effects during the study, this shows a lack of understanding of the risks and a failure to seek medical advice or appropriately deselect from using OPill.
FDA asked that one-third of study participants should have limited literacy. The breast cancer self-selection study and ACCESS studies had far fewer participants with limited literacy. Although it’s challenging to recruit participants with limited literacy, FDA’s request was important so that the results would be generalizable to the expected consumer population.
Finally, while only 1% of participants used OPill while also using another hormonal contraceptive, this would translate to dangerous use by tens of thousands of patients in the U.S.
We urge this panel to consider these concerns and whether they can be addressed if OPill is sold OTC.
Thank you