FDA greenlights first 'smart' pill
- The Food and Drug Administration has approved a digital pill that tracks if and when patients take their medication.
- The first-of-its kind drug, called Abilify MyCite, contains an ingestible sensor first approved by the FDA in 2012 and is meant to address the problem of prescription noncompliance. Abilify has long been used to treat schizophrenia and bipolar disorder.
- Not everyone is excited about the smart drug. Peter Kramer, a psychiatrist and author of “Listening to Prozac,” told The New York Times the pill was akin to “packaging a medication with a tattletale” and said it could be a “potentially coercive tool.”
Forgetting to take medications as prescribed can decrease treatment efficacy and raise the risk of complications. The problem can be especially acute for patients with memory impairment. A 2014 analysis from the Johns Hopkins Bloomberg School of Public Health estimated the cost of medical noncompliance at up to $300 billion a year.
FDA Commissioner Scott Gottlieb has said he wants to streamline the path to market for digital health products and clarify the agency’s position on tools like mobile apps. Key to that plan is a pilot program that would facilitate third-party certification for low-risk digital products.
The agency also plans to clarify how the 21st Century Cures Act will impact existing policies. Among other things, the 2016 law made clear that mobile lifestyle apps, such as FitBit, and clinical administrative support software won’t generally be regulated by the FDA. It also tasks the Office of the National Coordinator for Health IT with creating a “trusted exchange framework” to drive greater interoperability.
In announcing Monday’s approval, Mitchel Mathis, director of the Division of Psychiatry Products in FDA’s Center for Drug Evaluation and Research, said the agency “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.”
Abilify MyCite is a collaboration of Otsuka Pharmaceuticals and Redwood City, California, sensor developer Proteus Digital Health.