The Food and Drug Administration could approve the sale of birth control medication without a prescription for the first time by this summer.
A committee of independent experts who advise the FDA is set to meet Tuesday and Wednesday to make a recommendation on whether data submitted by HRA Pharma is sufficient to allow over-the-counter sales of Opill, the 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 sale of the pill, known generically as norgestrel, without a prescription.
However, FDA staff have raised concerns that some consumers who should not take norgestrel — or who need to consult their doctor first due to health conditions — did not understand the drug label warning in a study, according to an agency briefing document publicly released Friday
Despite that, HRA Pharma expects an FDA decision on the request later this summer, according to a spokesperson for the Paris-based drugmaker, which is owned by the consumer health-care company Perrigo.
Oral contraceptives first entered the U.S. market more than 60 years ago, and since then have required a doctor’s prescription. The FDA approved prescription sales of HRA Pharma’s birth control pill in 1973.
HRA Pharma originally asked the FDA to approve sales of Opill in July 2022, just two weeks after the Supreme Court overturned its own ruling in the case known as Roe v. Wade.
The Supreme Court‘s decision meant there was no longer a right to abortion under the U.S. Constitution. That triggered a series of legal restrictions on abortion in a number of states, and also led to calls for expanded access to contraceptives and to medication that can end a pregnancy.
Medical associations such as the American College of Obstetricians and Gynecologists for years have supported over-the-counter access to birth control without age restrictions.
In March 2022, more than 50 members of Congress urged FDA Commissioner Dr. Robert Califf to review applications for over-the-counter sales of birth control 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 getting birth control due to systemic inequities in our healthcare system.”
The concerns by FDA staff about whether enough people will understand Opill’s warning label are focused 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 medication contains progestin, which can increase the risk that tumors will reoccur.
Women who have experienced unexplained bleeding between menstrual cycles are supposed to consult with their doctor to make sure norgestrel is safe for them.
HRA Pharma, in its own briefing document released last week, said that 97% of 206 participants in a study who had a history of breast cancer understood the drug’s label and chose not to use the pill. Six participants incorrectly chose to use norgestrel despite their cancer history, the company said.
HRA Pharma said 22 women reported unexplained vaginal bleeding that they had not discussed with a doctor at study enrollment. Seven of these individuals chose to take Opill during the study. One of these participants spoke to a doctor during the study, while six did not.
The company said these six individuals did not consult a doctor because their bleeding was not frequent or they considered it to be normal.
A panel of doctors viewed norgestrel as appropriate for these women, HRA Pharma said.
The FDA also has raised concerns that Opill may not be as effective in the current U.S. population as the medication was when it was approved decades ago due to increasing rates of obesity, as well as lower adherence to a dosing regimen that requires taking the pill at the same time each day.
These factors could impact Opill’s effectiveness at preventing pregnancy in a nonprescription setting, according to the FDA.
FDA staff in their briefing document last week that they are not aware of any data from the past two decades on the effectiveness of the drug.
HRA Pharma’s briefing document said that the failure rate of progestin pills like Opill is low.
An estimated 7% of women who use such contraceptives will have an unintended pregnancy in the first year, according to the document.
That is about the same failure rate as the other type of birth control which contains both progestin and estrogen.