A leading expert panel said Wednesday that the contraceptive pill Opill should be sold without a prescription.
The Food and Drug Administration (FDA) panel voted unanimously to make the drug available over-the-counter. The agency’s leaders will now decide the fate of the drug and are expected to agree with their panel.
The drug, manufactured by the Irish firm Perrigo, is 94 percent effective in preventing unwanted pregnancy. It has been available by prescription since the 1970s.
Scientists gathered by the FDA discussed the decision for two days and concluded that it is safe to use without a doctor’s supervision.
If the agency follows the non-binding recommendation, Opill would become the first birth control pill to emerge from behind the pharmacy counter. The company said sales could begin at the end of this year if approved.
Federal health advisers said Wednesday that the decades-old birth control pill should be sold over the counter, paving the way for a likely U.S. approval of the first over-the-counter birth control medication
On Tuesday, HRA Pharma presented evidence showing that the majority of eligible people took Opill correctly with no negative health consequences and followed instructions without the help of a medical professional.
This was a primary concern of FDA officials to make the pill available for purchase at any pharmacy.
“If we balance the benefits and risks, it would be hard for us to justify not taking this action,” said Maria Coyle, an Ohio State University pharmacist who chaired the panel.
“The drug is incredibly effective and I think it will be just as effective in the over-the-counter world as it is by prescription.”
The manufacturer also reported that teenagers and others who have difficulty understanding instructions for taking medicines could do so with Opill.
Approval of Opill for over-the-counter use would increase birth control options for more than 19 million American women living in areas without access to birth control methods.
“Over the counter Opill would give us an additional option of access and the more options available the better,” says Clare Coleman, president of the National Family Planning and Reproductive Health Association.
Also known as the minipill, Opill only contains progestin, unlike many alternatives that contain both progestin and estrogen.
Progestin is a form of progesterone, a naturally occurring reproductive hormone. It is used in various birth control methods and can be used to regulate menstrual cycles and treat reproductive disorders such as endometriosis.
Progestin-only pills are considered lower risk because estrogen pills can increase the risk of blood clotting.
Progestin thickens the mucus in the cervix, making it difficult for sperm to enter the uterus and fertilize an egg.
However, progestin-only pills don’t prevent ovulation as well as both progestin and estrogen pills, making them slightly less effective.
Estrogen is a hormone responsible for creating female sex characteristics, such as breasts and breast ducts, and also thickens the cervix.
However, it can lead to side effects, including bloating, nausea, breast tenderness, spotting, depression, and an increased risk of hypertension.
Opill may be unsafe for some groups of women. For example, people with breast cancer are at greater risk because the medication could accelerate tumor growth.
The Mayo clinic also advises that women with unexplained uterine bleeding and those with certain liver conditions avoid it.
Opill was first approved in the US five decades ago after data showed it was more than 90 percent effective in preventing pregnancy when taken daily.
However, the drug hasn’t been marketed in the US since 2005, so it’s unclear how popular it could be if approved for OTC use.
From 2017 to 2019, 65 percent of American women ages 15 to 49 were currently using birth control, according to the Center for Disease Control and Prevention.
The FDA’s Advisory Committee on Nonprescription Drugs and the Advisory Committee on Reproductive and Urological Drugs had two major concerns about designating Opill for over-the-counter use.
The first concern was obesity, which has become more common over time.
The number of states where at least 35 percent of residents are obese has nearly doubled since 2018. Currently, about four in ten Americans are medically considered overweight. In 1960 it was almost 13 percent.
Agency officials said: ‘While the original clinical trials for norgestrel tablets [mini-pill] not presenting data based on weight or BMI, the prevalence of adult obesity in the United States has changed dramatically since the original clinical trials were conducted more than 50 years ago.”
‘The extent to which efficacy of [Opill] is reduced in overweight or obese individuals (who collectively now represent about 60% of the US reproductive age population…) remains unknown,” they added.
The morning-after pill, also known as Plan B, appears to be slightly less effective in women with a body mass index above 30.
According to HRA Pharma’s review of a dozen different studies, a high BMI did not reduce the minipill’s effectiveness.
FDA officials also worried that making the pill available without a prescription would eliminate the ability for doctors to explain to patients the importance of taking the progestin-only pill daily within the same three-hour time frame, thereby the risk of missed or mistaken doses is increased. doubling the doses.
HRA Pharma addressed the concern in a comprehensive study called ACCESS, which mimicked an OTC environment to see if people were able to self-screen and take Opill properly. The study found that 93 percent of people taking the minipill did so on a schedule every day.
In addition, the three-hour window may be a bit wider than researchers once thought.
Perrigo said in his study of 880 patients that women will consistently use Opill daily if it is available over the counter. However, the FDA found several problems with the study, including more than 30 percent of participants reporting taking more pills than they actually received.
It’s unclear how much the drug will cost if approved for OTC use. While over-the-counter medications are often cheaper, they are generally not covered by insurance.
Requiring insurers to cover over-the-counter birth control would require a regulatory change by the federal government.