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.
- First, the guiding principle is “Patient Safety First.” No matter what we are doing, our primary focus needs to be on how to find ways to mitigate the risks of medications.
- Second, there is always more than one right answer. Using a science-based approach to proliferate options has become an essential part of the design process. An assortment of options enables you to identify multiple ways to achieve the first principle of patient safety; then you can pick from among those options to identify ways to achieve the secondary objectives described below.
- Third, select options that minimize the burden on healthcare professionals and maximize medication access for patients. It is easy to become preoccupied with satisfying FDA requests to gain regulatory approval. But it is essential to include healthcare professionals and patients in the REMS design process to ensure the program is as pragmatic and usable as possible. Risk communications can be engineered to be more effective by using Adult Learning Methods and other approaches that are documented to improve learning.
- Fourth, select the options that achieve patient safety and minimize burden while at the same time achieve corporate and shareholder objectives. Fiscal sustainability is essential. Patient safety and product sales are not mutually exclusive.
In discussions about risk management, many people feel awkward about the financial sustainability and responsibility to shareholders. But if we prioritize patient safety first, while simultaneously creating options that enable us to achieve multiple objectives, a balanced approach to risk management is achievable.