U.S. approves digital pill to track patients
U.S. regulators have approved the first drug with a sensor that alerts doctors when the medication has been taken, offering a new way of monitoring patients but also raising privacy concerns.
The digital pill approved Monday combines two existing products: the former blockbuster psychiatric medication Abilify — long used to treat schizophrenia and bipolar disorder — with a sensor tracking system first approved in 2012.
The technology is intended to help prevent dangerous emergencies that can occur when patients skip their medication, such as manic episodes experienced by those suffering from bipolar disorder.
But developers Otsuka Pharmaceutical Co. and Proteus Digital Health are likely to face hurdles. The pill has not yet been shown to actually improve patients’ medication compliance, a feature insurers are likely to insist on before paying for the pill. Additionally, patients must be willing to allow their doctors and caregivers to access the digital information.
These privacy issues are likely to crop up more often as drugmakers and medical device companies combine their products with technologies developed by Silicon Valley.
The new pill, Abilify MyCite, is embedded with a digital sensor that is activated by stomach fluids, sending a signal to a patch worn by the patient and notifying a digital smartphone app that the medication has been taken.
The FDA stressed however that there are limitations to monitoring patients. “Abilify MyCite should not be used to track drug ingestion in ‘real-time’ or during an emergency,” the statement said.
The Japanese drugmaker has not said how it will price the digital pill. Proteus Digital Health, based in Redwood City, California, makes the sensor.