U.S. regulators approved the first medicine with an embedded sensor to help keep track of whether patients with mental illness are adhering to their prescriptions.
The decision marks a milestone in the convergence of technology and health care that also raises privacy concerns.
The so-called digital pill is a version of Otsuka Pharmaceutical Co.'s Abilify, which treats depression, bipolar disorder and schizophrenia. The sensor, developed by Proteus Digital Health, 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 where missing medicines can result in a psychotic break which will land them in an ER."
The Food and Drug Administration's approval late 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.
"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. Through an app, patients can also opt to report activity, rest and mood information to share with their caregiver, the companies said.
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 anonymized, 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," Nath said.
Otsuka Pharmaceutical, which is a unit of Tokyo-based Otsuka Holdings Co., plans to start the program with just a handful of health systems and gather evidence on the drug's effects on adherence, he said.
Not all patients will appreciate such monitoring, says Lucia Savage, chief privacy and regulatory officer at Omada Health Inc., a startup focused on digital counseling programs for chronic conditions like diabetes.
"It creates a looking-over-your-shoulder effect," Savage said.
Information about mental illness is particularly sensitive, said Savage, who previously was a privacy officer at the Department of Human and Health Services.
She suggested patients and their physicians ask questions like, "How is the data flowing? Where does the signal go? If it goes to somebody's server, whose server is that? What are the business arrangements?"
Bob McQuade, Otsuka Pharmaceutical's chief strategic officer, said patients will have a choice. The company will continue to sell regular Abilify, he said, and generic versions of the drug are available as well.
Closely held Proteus is based in Redwood City, California.