A leading expert panel said Wednesday that the birth control pill Opill should be sold without a prescription.
The Food and Drug Administration (FDA) panel voted unanimously in support of making the drug available over-the-counter. Agency leaders will now decide on 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 at preventing unwanted pregnancy. It has been available via prescription since the 1970s.
Scientists gathered by the FDA discussed the decision over two days and came to the conclusion that it is safe to use without doctor’s monitoring.
If the agency follows the nonbinding recommendation, Opill, would become the first contraceptive pill to be moved out from behind the pharmacy counter. The company said sales could begin late this year if approved.
Federal health advisers said Wednesday that the decades-old birth control pill should be sold without a prescription, paving the way for a likely U.S. approval of the first over-the-counter contraceptive medication
On Tuesday, HRA Pharma presented evidence that showed the majority of eligible people took Opill correctly without negative health effects and followed the instructions without a medical professional’s help.
This was a primary concern FDA officers had about making the pill available for purchase at any pharmacy.
‘In the balance between benefit and risk, we´d have a hard time justifying 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 effective in the over-the-counter realm just as it is in the prescription realm.’
The manufacturer also reported teenagers and others who may have trouble understanding instructions for using medication were able to do so with Opill.
Approving Opill for over-the-counter use would widen birth control options for more than 19 million US women living in areas without access to contraceptive methods.
‘Opill over the counter would give us one more option for access and the more options that are available the better,’ said Clare Coleman, president of the National Family Planning and Reproductive Health Association.
Also called the mini-pill, Opill contains progestin only, unlike many alternatives that have both progestin and estrogen.
Progestin is a form of progesterone, a naturally occurring reproductive hormone. It’s used in several methods of birth control, and it can be used to regulate menstrual cycles and treat reproductive conditions such as endometriosis.
Progestin-only pills are considered lower risk because pills with estrogen can increase the risk of blood clotting.
Progestin thickens 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 pills with both progestin and estrogen, which makes them slightly less effective.
Estrogen is a hormone responsible for creating female sexual characteristics, such as breasts and mammary ducts, also thickens the cervix.
It can, however, lead to side effects, including bloating, nausea, breast tenderness, spotting, depression, and an increased risk of hypertension.
Opill could be unsafe for some groups of women. People with breast cancer, for example, 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 diseases 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 medication hasn’t been marketed in the US since 2005, so it’s unclear how popular it might be if it’s approved for OTC use.
From 2017 to 2019, 65 percent of American women aged 15-49 were currently using birth control, according to the Centers for Disease Control and Prevention.
The FDA’s Nonprescription Drugs Advisory Committee and the Reproductive and Urologic Drugs Advisory Committee had two main concerns about designating Opill for over-the-counter use.
The first concern included obesity, which is becoming more prevalent over time.
The number of states in which at least 35 percent of residents have obesity has nearly doubled since 2018. Currently, about four in 10 Americans are deemed medically too fat. In 1960, it was closer to 13 percent.
Agency officials said: ‘Although the original clinical trials for norgestrel tablet [mini-pill] do not present data based on weight or BMI, the prevalence of obesity in adults in the United States has changed dramatically since the original clinical studies were conducted over 50 years ago.’
‘The degree to which efficacy of [Opill] is diminished in individuals who are overweight or obese (which together now represent approximately 60% of the U.S. reproductive-aged population … ) remains unknown,’ they added.
The morning-after pill, also referred to as Plan B, has been shown to be slightly less effective in women with a body mass index higher than 30.
According to HRA Pharma’s evaluation of a dozen different studies, a high BMI did not diminish the effectiveness of the mini-pill.
FDA officials also worried that making the pill available without a prescription would eliminate the opportunity for doctors to explain to patients the importance of taking the progestin-only pill daily within the same three-hour window of time, raising the risk of missed doses or mistakenly doubling up on doses.
HRA Pharma addressed the concern in an expansive study dubbed ACCESS, which mimicked an OTC environment to see whether people were able to self-screen and take Opill appropriately. The study found that 93 percent of people who were taking the mini-pill did so on schedule everyday.
Moreover, the three-hour window may actually be a bit wider than researchers once thought.
Perrigo said in its 880-patient study that women will consistently take Opill daily if it’s made available over the counter. However, the FDA found several issues with the study, including more than 30 percent of participants who reported taking more pills than they were actually supplied.
It’s unclear how much the drug will cost if approved for OTC use. Though nonprescription medications are often cheaper, they generally are not covered by insurance.
Requiring insurers to cover over-the-counter birth control would require a regulatory change by the federal government.
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