FDA Approves First Digital Pill That Can Track Whether You’ve Taken It

The FDA has approved the first drug with “a digital ingestion tracking system.” Abilify MyCite is an antipsychotic with an ingestible sensor that transmits data to a patch, which then sends the information to a smartphone app.
Proteus Digital Health

The Food and Drug Administration has approved its first digital drug: a pill embedded with a sensor that transmits whether someone has taken it.

Although the approval is a big step for digital medicine, there are concerns about privacy, convenience and cost.

The tablet and embedded sensor is called Abilify MyCite. Abilify, made by Japan-based Otsuka Pharmaceutical, is the brand-name version of aripiprazole, an antipsychotic drug used for treating schizophrenia, bipolar disorder and as an add-on treatment for depression in adults.

The tiny sensor, made by a company called Proteus, is about the size of a grain of sand. It’s activated when it comes into contact with fluid in the stomach. The sensor detects and records the date and time the pill is ingested.

The sensor transmits that information to a patch worn by the patient. The patch then sends the data to a smartphone application; the data can then be shared with selected family members or caregivers.

That’s a lot of moving parts, but the problem it aims to address is a real (and expensive) one: nonadherence, which is the term for patients not following through with prescribed treatment. Nonadherence is a problem for people with many kinds of health conditions, such as hypertension and high cholesterol.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Dr. Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

In its announcement, the FDA notes that Abilify MyCite’s labeling information states the product hasn’t been shown to improve patients’ compliance with their treatment regimen. It also says that “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.”

Some health experts were surprised that the first digital drug to be approved by the FDA is an antipsychotic, because some people who have schizophrenia experience paranoia and delusions that they are being watched.

Taking a pill that transmits data from their body to others might not be desirable to these patients.

“Many of those patients don’t take meds because they don’t like side effects, or don’t think they have an illness, or because they become paranoid about the doctor or the doctor’s intentions,” Dr. Paul Appelbaum, director of law, ethics and psychiatry at Columbia University’s psychiatry department, told The New York Times.

“A system that will monitor their behavior and send signals out of their body and notify their doctor?” Appelbaum said. “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.”

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SOURCE: NPR – Laurel Wamsley