November 15, 2017•Update: November 15, 2017
By Barry Eitel
SAN FRANCISCO
The U.S. Food and Drug Administration (FDA) on Monday approved a “digital pill” for the first time ever, but a consumer advocate group said Tuesday its users should be wary.
The pill is equipped with a tiny sensor that transmits data about whether the patient had taken the pill or not.
Though the move has been lauded as a milestone for the infant field of digital medicine, some are raising concerns about privacy and costs.
Named Abilify MyCite, the medication is produced by Otsuka Pharmaceutical based in Japan and is outfitted with a sensor built by a company called Proteus Digital Health. Abilify, the drug, is an antipsychotic medicine used to treat mental illnesses like bipolar disorder and schizophrenia.
The sensor, about the size of a grain of sand, is activated when it comes into contact with stomach acid. It transmits data to a patch that, in turn, can send information to a smartphone app that lets family members or caretakers know that a patient took the medication.
“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a statement Monday.
“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.”
The creators of Abilify MyCite believe it will lead the way toward other medications solving the issue of nonadherence, i.e., when patients do not follow the treatment instructions of their doctors.
“The time is right for the category of digital medicines to be available to appropriate patients with serious mental illness,” Proteus CEO Andrew Thompson said in a statement released Tuesday.
“Consumers already manage important tasks like banking, shopping and communicating with friends and family by using their smartphones as they go about their daily lives.”
The ability to track someone’s medicine intake, however, is unnerving some digital privacy advocates like the Electronic Frontier Foundation.
“Before you swallow one of these — just like with any other device — make sure you know what sensitive medical data is being collected about you and how it's being used and stored,” the group said Tuesday on Twitter.
