Opill oral contraception
The Food and Drug Administration on Tuesday raised significant concerns about a drugmaker’s application to sell a birth control pill without a prescription.
A panel of independent experts advising the FDA is meeting Tuesday and Wednesday to make a recommendation on whether data presented by HRA Pharma is sufficient to allow Opill, the company’s contraceptive, to be sold over-the-counter.
The FDA is not required to follow the advice of its outside experts, but their recommendations play an important role in the agency’s decisions.
Opill, commonly known as Norgestrel, could become the first over-the-counter birth control pill in the US since oral contraceptives first hit the US market more than 60 years ago.
HRA Pharma expects an FDA decision on the application in the summer, according to a spokesman for the Paris-based drugmaker, which is owned by healthcare company Perrigo.
Medical associations such as the American College of Obstetricians and Gynecologists have supported over-the-counter access to birth control without age restrictions for years.
HRA Pharma originally asked the FDA to approve the sale of norgestrel in July, just two weeks after the Supreme Court delivered its own ruling in the Roe v. Wade had overturned the known case.
The Supreme Court’s decision meant abortion was no longer a right under the US Constitution. This sparked a raft of legal restrictions on abortion in a number of states, and also led to calls for expanded access to contraceptives and drugs capable of terminating pregnancy.
But FDA officials have raised concerns that some consumers who shouldn’t take norgestrel — or who need to consult their doctor first because of health conditions — didn’t understand the warning on the drug’s label in a study, according to an agency briefing document released Friday has been published.
FDA officials also said that a third of the participants reported taking more norgestrel tablets than were actually dispensed in the study, an issue the agency described as “unlikely dosing.”
The underlying reasons for these errors are unclear, but raise significant questions about the accuracy of the study results, according to the FDA.
“I just wanted to note that this finding of an unlikely dose in this study is really quite extraordinary,” said Dr. Teresa Michelle, who heads the FDA’s Office of Non-Prescription Drugs, before the advisory committee on Tuesday.
“In order for us to address the fact that consumers have reported doses they didn’t take,” Michelle said, “they have to over-report so much that they are reporting dosages in excess of the number of pills they are given.” .” She said this raised concerns about whether other data was inaccurate, but the FDA just didn’t take it up.
Breast Cancer Warning
FDA officials’ concerns also focused on whether consumers will understand norgestrel’s warning that women with breast cancer should not take the pill and that women with vaginal bleeding should see a doctor first.
Women with a history of breast cancer should not take norgestrel because the drug contains progestins, which can increase the risk of tumors coming back.
HRA Pharma said in its own briefing document released last week that 97% of 206 participants in a study who had breast cancer understood the drug’s label and had chosen not to use the pill. Six participants incorrectly chose norgestrel despite their history of cancer, the company said.
But the FDA said only 5% of the participants had limited literacy skills, so it’s unclear if the study results would hold up in the general population.
dr Pamela Goodwin, an oncologist, said the majority of women diagnosed with breast cancer are older than 50, which is commonly considered by doctors to be the reproductive age.
About 25% of women diagnosed with breast cancer are under the age of 50, and about 40% of women in this group want to use contraception, said Goodwin, who was presenting for HRA Pharma.
About three-quarters of this population use IUDs or IUDs, meaning about 2.5% of breast cancer patients may be interested in using norgestrel, said Goodwin, a professor of medicine at the University of Toronto.
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According to the drug’s label, women who have experienced unexplained bleeding between menstrual cycles should consult their doctor before taking norgestrel.
According to HRA Pharma, 22 women in the study reported unexplained vaginal bleeding that they did not discuss with a doctor when they enrolled. Seven of these people chose to take norgestrel during the study. One of these participants spoke to a doctor during the study, while six did not.
The company said those six people did not see a doctor because their bleeding was not frequent or they thought it was normal.
A panel of physicians considered norgestrel suitable for these women, HRA Pharma said.
dr Anna Glasier, an expert in reproductive medicine, told FDA advisers that abnormal vaginal bleeding is a very common condition. Most women don’t consult a doctor about the problem because these episodes usually resolve spontaneously, said Glasier, who was presenting on behalf of HRA Pharma.
Glasier said women should not be held hostage by requiring them to see a doctor for a safe and effective form of birth control.
questions about effectiveness
The FDA has also raised concerns that norgestrel may not be as effective in the current US population as the drug was when it was approved decades ago, due to increasing obesity as well as reduced adherence to a dosing regimen that requires taking the pill every day same time.
These factors could affect norgestrel’s effectiveness in preventing pregnancy in a non-prescription setting, according to the FDA.
FDA officials said in their briefing document last week that they were not aware of any data on the drug’s effectiveness over the past two decades.
Glasier said it’s true that clinical trials leading to approval of birth control pills like norgestrel were conducted at a time when study standards weren’t as strict as they are today.
But Glasier said birth control pills like norgestrel have been used by millions of women for decades and have stood the test of time. She said it’s now clear if these birth control pills weren’t effective in preventing pregnancy.
HRA Pharma’s briefing document states that the failure rate of progestogen pills like norgestrel is low.
According to the document, an estimated 7% of women using such contraceptives become pregnant in the first year.
That’s about the same failure rate as the other type of birth control that contains both progestin and estrogen.