December 14, 2017

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FDA Approves First Digital Pill

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.

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About this Author

Yodi Hailemariam, Drinker Biddle Law Firm, Washington DC, Cybersecurity Law Attorney
Associate

Yodi S. Hailemariam focuses her practice on U.S. and cross-border information governance, data privacy, cybersecurity, electronic discovery, legal analytics and the Internet of Things. Yodi has experience in a wide range of industries, including health care, pharmaceuticals and life sciences, intellectual property, insurance and financial services.

A frequent author, speaker and panelist on “all things data,” Yodi advises companies regarding electronic discovery in complex civil litigations, white collar defense, and corporate...

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