Home / News & Analysis / Get Ready for Digital Pills: FDA Clears Self-Tracking Drug

Get Ready for Digital Pills: FDA Clears Self-Tracking Drug

It might sound creepy, but US regulators have approved a drug that can digitally track whether patients have taken their medicine.

It's the first drug in the country with a digital ingestion tracking system, according to the Food and Drug Administration, which announced the approval on Monday. However, the medication is geared only for people diagnosed with certain kinds of mental illness.

Called Abilify, the purely chemical version of the drug actually received FDA approval over a decade ago to treat patients with schizophrenia and bipolar disorders.

However, the makers behind it, Japanese company Otsuka Pharmaceutical, developed a new version called Abilify MyCite that comes with a tiny ingestible sensor inside each pill.

The sensor is the size of a grain of sand and made from magnesium and copper, according to Proteus Digital Health, the maker of the technology.

Patients wear a patch over their torso, which relays a signal between the drug pill and the mobile app. The sensor in the pill will then activate once its swallowed and reaches the patient's stomach fluid.

The patch on the torso can also transmit the signal to a web service, where a doctor can examine the data.

On Monday, the FDA said the digital drug pill might be useful for some patients. However, Abilify MyCite's own prescription labeling says it still hasn't been shown the drug improves "patient compliance" with their treatment, according to the FDA.

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Nevertheless, the regulatory approval is a big win for Proteus, which has been promoting its self-tracking pill technology as a way to help patients take their medicine as prescribed.

In addition, the company says the ingestible sensor can be used to track psychological data, like the person's activity level. With the patient's consent, that data can then be shared with a doctor and family members to help manage the mental illness, Proteus has said in past statements, lobbying for the FDA to approve the drug.

However, the idea of a self-tracking pill technology probably won't be welcomed by all. Comedian Stephen Colbert lampooned the tech back in 2012, joking, "Nothing is more reassuring to a schizophrenic than a corporation inserting sensors into your body."

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