FDA scientists have raised concerns about whether the public, particularly adolescents and people with lower literacy levels, will understand norgestrel’s drug label and use the medication the right way.
The FDA also found one-third of participants in HRA Pharma’s study reported taking more norgestrel pills than were actually dispensed. Dr. Theresa Michele, head of the FDA’s nonprescription drug division, said these errors call into question whether other data in the study is reliable.
“I can’t think of a study that has 30% invalid data,” Michele told the committee. “That really just does not occur in any kind of a study, much less a consumer study of this nature, so it’s really very extraordinary.”
“We went back and asked the sponsor to look for a root cause of this and they didn’t find one” Dr. Michele said.
Dr. Karen Murry, a deputy director of the FDA’s nonprescription drug office, said HRA Pharma submitted a study that was difficult to interpret. “The FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively in the nonprescription setting,” she said.
The FDA was also worried some women with a history of breast cancer in HRA Pharma’s drug label comprehension study chose to take norgestrel despite a warning they should not. Progestin can increase the risk of breast cancer returning.
Dr. Pamela Goodwin, an oncologist at the University of Toronto, told the committee most women diagnosed with breast cancer are older than 50 and beyond reproductive age. There’s a small population of reproductive-age women diagnosed with breast cancer who may want to use oral contraception, but they are in constant contact with their doctor and are unlikely to use a medication that would increase their risk of cancer coming back.
Dr. Anna Glasier, an expert on reproductive medicine, told the committee Tuesday most women do not consult a doctor about unexplained vaginal bleeding because these episodes are common and typically resolve spontaneously. Glasier also testified on behalf of HRA Pharma.
“Let’s not hold women hostage to having to see a doctor to get this extremely safe and effective…progestin-only birth control pills such as norgestrel.”