FDA OKs First ‘Digital Pill’ That Lets Doctors Know It’s Been Taken

Offering both the promise of better patient compliance with health care, but also fears of a medical “Big Brother,” a newly approved “digital pill” allows physicians to track whether or not it’s been ingested by patients.

The U.S. Food and Drug Administration has given the nod to Abilify MyCite, for use in patients with schizophrenia, an add-on treatment for depression, and to help control episodes of either manic or “mixed” episodes for people with bipolar disorder.

As explained in an FDA news release, the pill contains a sensor that communicates with a wearable patch. This patch in turn sends signals to the patients’ smartphone, telling them whether or not they’ve taken the pill, along with the pertinent dates and times.

“Patients can also permit their caregivers and physician to access the information through a web-based portal,” the FDA noted — opening the possibility that others can track a patient’s adherence (or lack thereof) to drug therapy.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Dr. Mitchell Mathis, director of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in the news release. “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.”

Otsuka Pharmaceutical and Proteus Digital Health, which jointly make Abilify MyCite, said in a news release Monday night that the pill is a logical advance in today’s high-tech, connected world.

“The time is right for the category of Digital Medicines to be available to appropriate patients with serious mental illness,” said Proteus CEO Andrew Thompson. “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. With this FDA approval, Otsuka can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way.”

Noncompliance with medical regimens is a tough problem, especially when it comes to patients with serious mental health issues, such as schizophrenia, depression and bipolar disorder.

According to The New York Times, medical noncompliance costs the United States $100 billion annually, mainly because failure to adhere to treatment leads to sicker patients who often require expensive hospitalization.

But some doctors worry that digital medications could present their own problems, as patients feel “tracked” by medical professionals and others.

“If used improperly, it could foster more mistrust instead of trust,” Ameet Sarpatwari, an instructor in medicine at Harvard Medical School, told the Times.

And psychiatrist Dr. Peter Kramer, who wrote “Listening to Prozac,” said drugs like Abilify Mycite come with a built-in “tattletale.”

A ” ‘digital drug’ sounds like a potentially coercive tool,” he told the Times.

The newspaper noted that similar digital drugs are being developed for a range of conditions, including heart disease, stroke, HIV and diabetes.

More information

There’s advice on taking your meds as directed at the American Heart Association.