Dr. Jenkins–
I have seen your recent comments on providing REMS programs for opioids. Since you are the director of OND, I was hoping to give you some feedback on these programs, and to alert you to the adverse effect on patient care that they can have.
I am a clinical hematologist and oncologist. I have to contend with many drugs under these programs, including Promacta, Nplate, Thalomid, Tysabri, and Revlimid. Looks like opioids are next on the list. (more…)
One of the more challenging aspects of the new FDA world of REMS is the tension it can create among various functional groups such as Marketing, Risk Management, Safety and Medical within a Pharma or Biotech company. Rules are unclear. Territories are vaguely defined. New objectives seem similar to the old but may not be in reality. And it involves many players, across most internal disciplines. Maybe it’s time that we all think of this as a cross-disciplinary sport that no one really knows how to play well, yet.
The urgency of the new regulatory environment is simply demanding some quick innovative thinking and action.
Some of our clients and others are addressing this new “X-Disciplinary Sport” to good advantage. There are a number of principles that, if kept at the forefront of thinking, can help you re-organize and align your teams around this new REMS-driven world. (more…)
Developing an effective REMS program – one designed to preserve access for every person who would benefit from a medication while avoiding exposure in situations and individuals with excessive risk factors – is a challenge. The difficulty increases when the risks expand beyond inadvertent misuse to also include intentional abuse.
Recently the FDA signaled its intent to tackle risks involving opioids that have both significant benefits for certain segments of patients and also the potential for misuse and abuse. On March 3, the FDA will sit down with 15 manufacturers of 24 opioid medications to begin the process of outfitting them with REMS.
(more…)
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