As FDA advisers consider OTC birth-control pill, agency scientists worry it won't work due to women's weight and likelihood of following label

As FDA advisers consider OTC birth-control pill, agency scientists worry it won't work due to women's weight and likelihood of following label


Caitlyn moved to Hong Kong from the United States three years ago for a teaching position. She loved the food, sights, and birth control.

She was surprised to discover that she could buy oral contraceptives in her local drugstore, without a prescription.

"My jaw dropped probably the first time I tried it. I walked into the room and looked around, thinking 'is this actually happening?' Pace, 34, said. It's just like buying aspirin.

Medical organizations have been fighting for years to make birth control pills available in the US.

A group of external advisors to the US Food and Drug Administration (FDA) will meet on Tuesday and Wednesday to discuss a request from a pharmaceutical firm to make their prescription birth-control pill available over-the counter.

The FDA is skeptical about the over-the counter sale of Opill, even though professional organizations such as the American Medical Association and American College of Obstetricians and Gynecologists have supported it. In a 130-page online document published on Friday, they cite a number of concerns.

Dr. Kristyn brandi, spokesperson for the American College of Obstetricians and Gynecologists, stated that she was concerned about the FDA decision.

Weight concerns? Follow the label

Scientists at the FDA have expressed two major concerns regarding Opill, which is a "mini pill" that only uses progestin.

One is obesity. In 1973, the FDA approved Opill for prescription. Since then, the prevalence of obesity among adults in the United States, which was 13% in 1960, has increased to 42%.

The researchers added that 'the degree to which the efficacy [of Opill] is reduced in overweight or obese individuals (which now represents approximately 60% of U.S. reproductive age population) remains unknown.

The agency cited an analysis of data from four different studies, which suggested that women who are obese have a higher risk of getting pregnant after using emergency contraception. The authors noted that the data from these four studies were 'limited' and of a 'poor to fair' quality.

Brandi was shocked by the FDA's statement.

The American College of Obstetricians and Gynecologists, in a document for their members, cites several research studies that show that "women who are obese can be offered hormonal contraceptive methods with the reassurance that efficacy of hormone contraception isn't significantly affected by weight."

Brandi, an obstetrician-gynecologist in New Jersey, noted that even though obesity has been on the rise, there has not been a higher rate of failure for birth control pills.

Scientists at the FDA were also concerned about studies conducted by Perrigo (the company that makes Opill) that showed that some women did not follow the instructions on the label. The FDA scientists said that some women who took the Opill pill in the study did not take it within the same 3-hour window each day. This is crucial for effectiveness.

Brandi says that even though doctors prescribe medication, some patients do not take it properly.

She said, 'They are human, and that's okay.' People are human, and that is OK.

Opill's label advises women to take their pill immediately after remembering it if they are more than three hours behind schedule. They should also use an alternative form of birth-control, like a condom for two days.

Brandi stated that she trusted patients to be able read and follow instructions, and to be able use medication safely and efficiently. 'I'm not worried, because I believe in women.' I trust my patient'

Perrigo stated that the 'data collected from our eight-year development program shows that consumers can safely use Opill as directed by the proposed labelling'

The FDA expressed concern as well that women may not be aware when Opill isn't right for them without a doctor's advice.

The Opill label, for example, states that women with a breast cancer history should not use the drug. Six of the 205 women with a breast cancer history who read the label said that the pill was the right choice for them.

Opill is not recommended for women with undiagnosed abnormal uterine bleeding. However, in a recent study, over half of the women with this condition felt that it was suitable for them.

Letter from the lawmakers

Health care providers and elected officials are putting pressure on the FDA to allow Opill over-the counter.

According to a FDA document, almost half of pregnancies in the US are unintended. Rates are higher among women with lower incomes, Black women, and women who have not completed high school.

In March 2022 59 members sent a letter about OTC contraception to FDA Commissioner Robert Califf.

This is a crucial issue for reproductive rights and justice. The lawmakers stated that despite decades of safety and effectiveness being proven, many people face enormous barriers in getting birth control because of systemic injustices in our healthcare system.

Califf replied that FDA "acknowledges public health benefits from increased access to oral contraceptives" and that "the Agency's decisions are guided by the best science available."

The FDA advisors will vote on Wednesday whether or not to recommend the FDA approve Opill for over-the counter sale. The FDA often heeds the advice of its advisors, but not always.