Opill oral contraception
The Food and Drug Administration could authorize the sale of contraceptive drugs without a prescription for the first time by the summer.
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 obligated to follow the advice of its outside experts.
But a positive recommendation would argue strongly for allowing the pill, commonly known as norgestrel, to be sold without a prescription.
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.
Still, HRA Pharma expects an FDA decision on the application in the summer, according to a spokesman for the Paris-based drugmaker, which owns the consumer healthcare company Perrigo.
Oral contraceptives first entered the US market more than 60 years ago and have required a doctor’s prescription ever since. The FDA approved the sale of prescription norgestrel contraceptive pills in 1973. Prescription norgestrel was discontinued in the United States in 2005 for business reasons.
There are two main types of birth control pills: Drugs like norgestrel only contain progestin, a hormone involved in the menstrual cycle. Other birth control pills contain progestin and estrogen.
HRA Pharma originally asked the FDA to approve the sale of norgestrel in July 2022, just two weeks after the Supreme Court delivered its own ruling in what was considered Roe v. Wade had overturned the known case.
The Supreme Court’s decision meant that there was no longer a constitutional right to abortion. 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.
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.
In March 2022, more than 50 members of Congress urged FDA Commissioner Dr. Robert Califf to promptly consider applications for over-the-counter contraceptive sales.
“This is a critical issue for reproductive health, rights and justice,” lawmakers wrote.
“Despite decades of proven safety and effectiveness, people still face immense barriers to access contraception due to systemic inequalities in our healthcare system.”
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FDA officials’ concerns about whether enough people will understand norgestrel’s warning focus on women with a history of breast cancer and women with unexplained vaginal bleeding.
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.
Women who have experienced unexplained bleeding between menstrual cycles should consult their doctor to make sure norgestrel is safe for them.
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.
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.
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.
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.
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