In April of 2019, then FDA Commissioner Scott Gottlieb used the phrase “Bad Actor” to describe individuals who were “taking advantage of patients, and putting them at serious risk, for their own financial profit.” Since then, the FDA has sent out more than a few warning letters, and has sought several injunctions, to protect patients from unproven, and potentially harmful, therapies.
Opposite these Bad Actors, though far less publicized, are a growing number of “Good Actors”. These are the practitioners and healthcare manufacturers who abide by the current regulations, and seek to demonstrate the safety, efficacy and applicability of their therapeutics to a broadening number of painful, costly and pervasive conditions. This is increasingly accomplished, as detailed by the FDA, EMA, and many other global regulatory agencies, through the design, capture and interpretation of longitudinal real-world clinical evidence. Such evidence has never been easier to capture, and with the proper infrastructure in place, actually incentivizes HCP and patient participation.
Since 2015, Regen Med has helped numerous healthcare manufacturers implement evidence-based solutions that achieve “Good Actor” status for themselves and their clinical customers. We have the technology, network and international clinical/scientific excellence to provide customer-specific, turn-key solutions.