The Food and Drug Administration (FDA) has approved the first drug in the United States to have a digital ingestion tracking system, but the drug has many skeptics.
Abilify MyCite has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults.
The system works by sending a message from the pill's sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physicians to access the information through a web-based portal.
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients," noted Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "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."
When it comes to patients, Twila Brase of Citizens' Council for Health Freedom stressed that they do sign a consent form for the doctor and other individuals to have access to the tracking data, but she also indicated that it is not clear whether there will be an option without the tracking device.
"Once you have a tracking device in here and it's made available for this purpose, my concern is that lawmakers and others will find reasons where they will create laws about requiring certain medications that have tracking devices to be used – and that the tracking devices will actually be used for access by the doctor," she pointed out. "I can just see that happening with certain types of cases with certain types of illnesses where the lawmakers get involved and they actually require the tracking – simply because a tracking device is available."