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FDA Approves First Digital Pill

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The U.S. Food and Drug Administration has approved the country’s first drug with a digital ingestion tracking system.

Abilify MyCite is a pill that digitally tracks whether patients have taken the medication.  The pill contains a sensor that, once ingested, sends a message to a patient’s wearable patch, which then transmits the information to a smartphone application.  This voluntary process allows patients, caregivers, and physicians to track this information through a web-based portal if the patient has given consent.  Experts believe that such digital devices could have a positive impact on public health by addressing a longstanding problem; in this case, that patients do not take their medicines as prescribed.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said 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.”

The FDA’s approval of Abilify MyCite takes us another step closer in the combining of digital technology with medicine.

The material contained in this communication is informational, general in nature and does not constitute legal advice. The material contained in this communication should not be relied upon or used without consulting a lawyer to consider your specific circumstances. This communication was published on the date specified and may not include any changes in the topics, laws, rules or regulations covered. Receipt of this communication does not establish an attorney-client relationship. In some jurisdictions, this communication may be considered attorney advertising.

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November 17, 2017
Written by: Discerning Data Editorial Board
Category: Health Care, Privacy
Tags: FDA

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