Opill Oral Contraception
THE Food and drug administration could approve the sale of contraceptive drugs without a prescription for the first time by this summer.
A committee of independent experts advising the FDA is meeting Tuesday and Wednesday to make a recommendation on whether the data submitted by HRA-Pharma is sufficient to allow the over-the-counter sale of opilthe company’s contraceptive.
The FDA is not obligated to follow the advice of its outside experts.
But a positive recommendation would weigh heavily in favor of allowing the pill, known generically as norgestrel, to be sold without a prescription.
However, FDA Staff have raised concerns that some consumers who shouldn’t take norgestrel – or who need to see their doctor first because of health concerns – haven’t understood the warning on the label of the drug in a study, according to an agency briefing released Friday.
FDA staff also said that one-third of participants reported taking more norgestrel tablets than were actually given out in the study. The underlying reason for these errors is unclear but raises important questions about the accuracy of the study results, according to the briefing paper.
Even so, HRA Pharma expects an FDA decision on the application this summer, according to a spokesperson for the Paris-based drugmaker, which is owned by the consumer healthcare company. Perrigo.
Oral contraceptives first entered the US market over 60 years ago, and since then they have required a doctor’s prescription. The FDA approved prescription sales of norgestrel birth control pills in 1973. Prescription norgestrel sales ceased in the United States in 2005 for marketing reasons.
There are two main types of birth control pills: Medications like norgestrel contain only progestin, a hormone that plays a role in the menstrual cycle. Other birth control pills contain progestins and estrogen.
HRA Pharma originally asked the FDA to approve sales of norgestrel in July 2022, just two weeks after the Supreme Court overturned its own decision in the case known as Roe v. Wade.
The Supreme Court’s decision meant that there was no longer a right to abortion under the Constitution. This triggered a series of legal restrictions on abortion in a number of states and also led to calls for expanded access to contraceptives and drugs that can end a 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 review applications for the sale of over-the-counter contraceptives without delay.
“This is a critical issue for reproductive health, rights and justice,” the lawmakers wrote.
“Despite decades of proven safety and effectiveness, people still face immense barriers to obtaining birth control due to systemic inequities in our healthcare system.”
FDA staff concerns about whether enough people will understand norgestrel’s warning label focus on women with a history of breast cancer and those with unexplained vaginal bleeding.
Women with a history of breast cancer are not supposed to take norgestrel because the drug contains progestin, which can increase the risk of tumors recurring.
Women who have had unexplained bleeding between menstrual cycles should see their doctor to make sure norgestrel is safe for them.
HRA Pharma, in its own brief published last week, said 97% of 206 study participants who had a history of breast cancer understood the drug’s label and chose not to use the pill. Six participants wrongly chose to use norgestrel despite having a history of cancer, the company said.
Dr. Pamela Goodwin, an oncologist, said the majority of women diagnosed with breast cancer are over 50, which is generally considered past childbearing age by doctors.
About 25% of women diagnosed with breast cancer are under age 50, and about 40% of women in that group want to use contraception, said Goodwin, who presented for HRA Pharma.
About three-quarters of this population use IUDs or intrauterine devices, which means about 2.5% of breast cancer patients might be interested in using norgestrel, Goodwin said, professor of medicine at the University of Toronto.
HRA Pharma said 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 these six people did not see a doctor because their bleeding was infrequent or considered normal.
A panel of physicians deemed norgestrel appropriate for these women, HRA Pharma said.
Reproductive medicine expert Dr. Anna Glasier told FDA advisers that abnormal vaginal bleeding is a very common condition. Most women don’t see a doctor about it because these episodes usually resolve on their own, said Glasier, who presented on behalf of HRA Pharma.
Glasier said women shouldn’t be held hostage to having 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 increased obesity rates, as well as lower adherence to a regimen that requires taking the pill at the same time each day.
According to the FDA, these factors could affect the effectiveness of over-the-counter norgestrel in preventing pregnancy.
FDA staff, in their briefing paper last week, said they were not aware of any data from the past two decades on the drug’s effectiveness.
Glasier said it’s true that the clinical trials that led to the approval of progestin-only birth control pills such as norgestrel were conducted at a time when study standards weren’t as rigorous as they are today. .
But Glasier said contraceptives like norgestrel have been used by millions of women over the decades and have stood the test of time. She said it would now be clear whether these birth control pills were effective in preventing pregnancy.
The HRA Pharma information document states that the failure rate of progestin-only pills like norgestrel is low.
An estimated 7% of women who use such contraceptives will have an unwanted pregnancy within the first year, according to the paper.
This is about the same failure rate as the other type of birth control that contains both progestin and estrogen.