The Internet of Pills: The FDA’s Approval of Digital Smart Pills Takes the Internet of Things to New Levels

If your insurance company knew that you did not take your medication as prescribed, could it deny future coverage? Could your physician refuse to continue to treat you? What if your medication was an anti-psychotic; could you be terminated from your employment? Could you be ordered to take it as a condition of parole? What other rights could be impacted?

These 1984 type questions are being asked today because the Food and Drug Administration has approved a “Smart pill” – i.e., a pill embedded with a digital sensor that records when, whether and in what amount you have taken your prescription medicine – for Abilify MyCite, a medicine for the treatment of schizophrenia and related disorders, which can include paranoia and delusions.

Proponents of digital medicine claim it will improve overall public health, especially for the forgetful among us. They point out that many patients with these types of conditions do not take their medication regularly, with severe consequences.

Opponents warn that the new data collecting pills can create an environment that coerces patients to become addicted to medicine they would otherwise not want to take. As quoted in the N.Y. Times, Dr. Paul Applebaum, director of law, ethics and psychiatry at Columbia University’s psychiatric department, warns that “[m]any of those patients don’t take meds because they don’t like side effects, or don’t think they have an illness, or because they become paranoid about the doctor or the doctor’s intentions.” He wonders why a drug treating these particular symptoms was chosen as the starting point for this new data gathering tool.

The medicinal, legal, and practical ramifications of this “Internet of Pills” will be played out in the courts, in doctors’ offices and in many unanticipated ways over the next several years.