The Food and Drug Administration has approved the 1st digital pill for the U.S. that tracks if patients have taken their medication. The pill referred to as Abilify MyCite is fitted with a tiny ingestible sensor that communicates with a patch worn by the patient — the patch then transmits medication data to a smartphone app that the patient will voluntarily upload to a database for their doctor and other approved persons to check. Abilify could be a drug that treats schizophrenia, bipolar disorder, and is an add-on treatment for depression.
The Abilify MyCite features a sensor the size of a grain of sand made from silicon, copper, and magnesium. an electrical signal is activated by the sensor when it comes into contact with stomach acid — the sensor then passes through the body naturally. A patch the patient wears on their left rib cage gets the signal several minutes after the pill is eaten. The patch then sends data just like the time the pill was taken and also the dose of a smartphone app over Bluetooth. The patch also records activity levels, sleeping patterns, steps taken, activity, and pulse rate, and should be replaced every seven days. The patient’s doctor and up to four other people chosen by the patient, as well as family members, will access the data. The patient will revoke access at any time.
The medicine comes out after years of research and could be a venture between Japanese pharmaceutical company Otsuka and digital medicine service Proteus Digital Health, that makes the sensor. The pill is one way to address the prevalent problem of patients not taking their medication properly, with the IMS Institute estimating that the improper and unnecessary use of drugs price the U.S. health care sector over $200 billion in 2012. The approval also opens the door for pills that are used for different conditions beyond mental health to be digitized.
Experts tho’, have expressed concerns over what the pill may mean for privacy. Some are worried that tracking pills are a step towards punishing patients who don’t obey. Ameet Sarpatwari, a professor of medicine at Harvard medical school told The NY Times the digital pill “has the potential to enhance public health. [But] if used improperly, it might foster more mistrust instead of trust.”
The Wall Street Journal reports that the Food and Drug Administration is anticipating a potential raft of approval requests for other digital pills. A spokesperson told the publication the FDA is going to hire more employees with “deep understanding” of software development in relation to medical devices and engage with entrepreneurs on new guidelines.
Otsuka hasn’t indicated how much the digitized Abilify pills can price yet. The WSJ reports the company plans to work with some insurers in covering the digitized pills with production planned to be ramped up only if it will find willing insurers.