Nicole Wetsman, The Verge: March 17, 2021
Digital birth control company Natural Cycles wasn’t happy with the news that the Food and Drug Administration cleared a second birth control app at the start of the month. The company, which was the first to get sign-off from the agency, says it’s glad to have the competition — but it takes issue with the way the FDA gave the new app, made by Clue, the okay.
The FDA can allow products to be sold and marketed in the US if they’re similar enough to something already available to consumers. In this case, the FDA is saying Clue is “substantially equivalent” to Natural Cycles — similar enough to earn the agency’s green light. But Natural Cycles doesn’t agree. “I feel this is slightly concerning,” Natural Cycles CEO Elina Berglund told The Verge.
These sorts of disagreements happen regularly in health care — usually in the back rooms of hospitals where companies jockey to sell their products to providers. For companies, touting the differences between physical medical devices, like surgical screws, infusion pumps, or heart monitors can make a difference in how much of their products they can sell. Now, companies are navigating the same discussions around digital health apps.
PATHWAYS TO CLEARANCE
Natural Cycles was cleared by the FDA as the first app-based birth control in 2018 — a controversial decision that came after the app was linked to unintended pregnancies in Sweden. It’s a digitized form of a type of pregnancy prevention called fertility awareness, where people monitor their menstrual cycles and other physiological signs to predict the windows when they could become pregnant. People who use this method then avoid sex or use other birth control methods, like condoms, during that time. Natural Cycles predicts these windows using data, including the dates of users’ periods and their body temperature, which changes around ovulation.
The Natural Cycles app is considered a medical device, not a drug, so the FDA didn’t review it in the same way it reviews a hormonal birth control pill. The agency also didn’t consider it a high-risk device, so it didn’t have to go through the most stringent clinical review process, a premarket approval. The FDA signed off on the device using a process called a de novo classification. This pathway is reserved for things that are unlike anything else on the market and the FDA considers low or medium risk. (It doesn’t think it will seriously hurt someone if something goes wrong.)
Like Natural Cycles, Clue isn’t considered a high-risk device, so it also didn’t have to get premarket approval. But it’s not novel: Natural Cycles was already available when Clue came online, so it didn’t have to go through the de novo process either. Instead, the FDA said the Clue app could be sold as a birth control because it was “substantially equivalent” to something that it already cleared.
The policy is based on the idea that if the agency clears a product, it’s safe and effective — and we can assume that anything that works in a similar enough way would also be safe and effective.
“Given that the category of ‘software application for contraception’ is already recognized by the FDA, Clue Birth Control and any future contraceptive app that raises similar regulatory questions can be assessed through the standard process for a recognized category,” a Clue spokesperson wrote in an email to The Verge.
It’s always a tricky line to walk, Cortez says. Companies like Clue want to argue that they’re close enough to earlier competitors that they can take the less-intensive clearance pathway. But they also have to market their products as better than competitors. “Companies will say, yeah, this is substantially equivalent to this other product, but it’s better in the following ways,” he says. “It can create some confusion.”
A back-and-forth over the relative similarities and differences between the two products highlights one criticism of the FDA’s oversight of medical devices — particularly devices it considers low or medium risk. A clinician’s metrics for the things that would make one device similar to another aren’t necessarily the same as the FDA’s. “The FDA definition is not the same definition that any normal human would use,” says Diana Zuckerman, president of the National Center for Health Research.
That’s part of Zuckerman’s concerns around medical devices cleared based on substantial equivalence. They don’t have to go through as rigorous a review process, and the decision is based on how similar two products are, not if the new product is independently safe. That’s worrying if the new device is being compared to a product that’s itself controversial, like Natural Cycles, Zuckerman says. “Even if it is substantially equivalent, how good is the product it’s supposed to be substantially equivalent to?”
It’s particularly concerning for something like a digital birth control, Zuckerman says. Saying that the apps aren’t high risk is a subjective call. The app may not directly harm someone in the way a faulty medication pump could. But pregnancy can be physically dangerous and have major consequences for people who were trying to avoid it. “If the product doesn’t work, there’s a high risk it could be very harmful,” she says.
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