This rigorous and mostly prudent approach makes perfect sense when evaluating potent biopharmaceutical products. After all, if the FDA makes a mistake it could endanger thousands of patients.
But such excessive caution isn’t warranted when it comes to a new breed of digital technologies designed to make medicines more effective by making patients more compliant. These technologies — which include ingestible, implantable, portable, and app-based monitoring and diagnostic tools — pose minimal safety risks. Therefore, FDA regulators should subject these products to less scrutiny. That would speed the approval process and enable patients to access these tools sooner.
Patients and their families are excited, rather than fearful or suspicious, about the potential of digital technologies.
Consider Abilify MyCite, a pill with a sensor that digitally tracks whether schizophrenia patients have ingested their medication. This technology could help boost abysmally low rates of medication adherence. Currently, three out of five schizophrenia patients do not take prescriptions as prescribed.
Enabling caregivers and family members to check whether patients have taken their pills could prevent patients’ mental health from deteriorating. The technology could spare patients and families much anguish and prevent costly hospitalizations, thereby lowering overall healthcare spending. Fortunately, the FDA approved the technology in November.
Researchers are incorporating similar sensors into other medications too. The tools could remind dementia patients to take their medicines. Or they could help a parent know if her child actually swallowed her pill or stuck it in her cheek and spit it out later.