US FDA approves a digital pill that can track when you swallowed it
US regulators approved the first medicine with an embedded sensor to help keep track of whether patients are adhering to their prescriptions, a so-called digital pill made by Otsuka Pharmaceutical Co and Proteus Digital Health.
The pill is a version of Otsuka’s Abilify, which treats depression, bipolar disorder and schizophrenia. The sensor, developed by Proteus, is activated by stomach fluids, sending a signal to a patch worn on the patient’s torso and transmitting the information to a smartphone app.
“This is the first time we’ll have an objective measurement of adherence,” said Kabir Nath, chief executive officer for North America at Otsuka Pharmaceutical. By allowing physicians to track a patient’s use, Nath said he hopes to avert “dramatic and immediate health-care crises, such as for schizophrenia patients were missing medicines can result in a psychotic break which will land them in an ER.”
The Food and Drug Administration’s approval Monday comes as the technology sector increasingly turns to health care to test advances like machine learning, artificial intelligence and micro-electronics for everything from drug development to insurance.
While many in the health industry are embracing new technology, others worry about protecting patient privacy as more data is generated and shared.
Patients who are prescribed the product, called Abilify MyCite, have to agree that their physicians can see the data. They can also choose whether or not to share information with caregivers, such as family members. Otsuka Pharmaceutical and certain insurers also plan to gather anonymised, aggregated data from patients who consent.
“We know some people don’t have relief of symptoms, and we don’t know if that’s just because they’re not taking their medication,” said Nath.