The FDA has approved the first smart pill for use in the United States. Called Abilify MyCite, the pill contains a drug and an ingestible sensor that is activated when it comes into contact with stomach fluid to detect when the pill has been taken. The pill then transmits this data to a wearable patch that subsequently transfers the information to an app on a paired smartphone. From that point, with a patient's consent, the data can be accessed by the patient's doctors or caregivers via a web portal.
The developer of the sensor and patch technology, Proteus Digital Health, joined forces with Otsuka Pharmaceutical Co., Ltd., which produces the schizophrenia drug Ablify, to develop the smart pill, and this is the first time such a device has been approved by the FDA.
The path to FDA approval has not been without problems, and despite each individual element (the drug and the sensor) already being approved by the FDA separately, the approval process for the Abilify MyCite has been delayed by FDA queries about the product's use and safety.
Although the pill has finally been given approval by the FDA, it comes with numerous caveats. Despite recognizing the ability of the technology to track the ingestion of medications by some patients with mental illnesses, the FDA said in a statement:
"It is important to note that Abilify MyCite's prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown. Abilify MyCite should not be used to track drug ingestion in "real-time" or during an emergency because detection may be delayed or may not occur."
The idea of a digital pill that records when it has been consumed is a sound one, but as the FDA notes, there is no evidence to say it actually increases the likelihood patients that have a history of inconsistent consumption will follow their prescribed course of treatment. There is also a very strange irony in schizophrenia being the first condition this technology is being used to target.
Sure, those with a mental illness may very well need a little more monitoring to make sure they take their medications, but will those suffering from a condition with hallmark symptoms of paranoia and anxiety be helped by consuming a technology that quite literally puts a tracking device inside their body? For patients hearing voices telling them that they're being watched, a monitoring device may be a hard pill to swallow.
"A system that will monitor their behavior and send signals out of their body and notify their doctor? You would think that, whether in psychiatry or general medicine, drugs for almost any other condition would be a better place to start than a drug for schizophrenia," says Paul Appelbaum, director of Columbia University's psychiatry department in an interview with the New York Times.
The new smart pill is set to be available on prescription from next year, but there's no word on how much the entire system will cost.