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Big Brother 2.0? FDA Approves World's First Electronic "Smart Pill"

Big Brother 2.0? FDA Approves World's First Electronic

The FDA approved usage of sensors in oral medication back in 2012, and some capsules have added sensors, but Abilify is the first where the sensor has been embedded directly in the pill.

There is no word yet on how much Abilify MyCite will cost, but it is set to roll out sometime next year. 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. The medication is indicated for the treatment of adults with schizophrenia, acute treatment of adults with manic and mixed episodes in bipolar I disorder, and as an add-on treatment for adults with depression.

Beginning in 2018, the launch of Abilify MyCite "will be conducted in close collaboration with only a select number of health plans and providers", according to a joint press release from Proteus Health Systems, the makers of the pill's digital sensor, and Otsuka Pharmaceutical Co., the maker of Abilify. A spokesperson told the publication the FDA is planning to hire more staff with "deep understanding" of software development in relation to medical devices, and engage with entrepreneurs on new guidelines.

When the pill is swallowed, a tiny sensor in the pill sends a message to a wearable patch.

The health-care community lit up in conversation after news broke that the US Food and Drug Administration (FDA) has approved the world's first digital drug.

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People who already take Abilify and switch to Abilify MyCite will not notice anything different about how the drug works to treat their symptoms, the FDA said in an email to TIME.

Patients wear a patch over their torso, which relays a signal between the drug pill and the mobile app. And as with most technological steps forward, it also raises questions about privacy, bioethics, and the use of big data from inside your body.

"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". It is also not approved for use in pediatric patients, and may increase suicidal thinking and behavior in children, adolescents, and young adults. In Abilify MyCite, skin irritation at the site of the MyCite patch may also occur. But the device may be particularly beneficial for certain patients with mental illness since taking medications as prescribed is particularly crucial for these people.

The US Centers for Disease Control and Prevention estimates that 6.7% of American adults experienced a major depressive episode in the past 12 months, while lifetime prevalence for bipolar disorder is almost 4% and for schizophrenia almost 1%. "The fact that someone might use this computer readout to decide if you are compliant-and that could affect your degree of freedom in society-is an issue that needs to be discussed and debated", she says.



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