The FDA’s decision to require manufacturers to develop Risk Evaluation and Mitigation Strategies (REMS) for their new or improved prescription opiates has had a widespread effect on these companies and their plans for distributing their pain relievers. As these companies scramble to develop REMS that will receive FDA approval and allow their products to be approved for distribution, many questions are generated as to exactly what the federal agency wants them to achieve and how to do it.
Of course, REMS for opiates have been mandated due to the continued rise in prescription drug abuse in our country. Some of this abuse is intentional, and some of it is accidental; nonetheless, the FDA is requiring some new ideas and strategies in an attempt to reduce this diversion problem in America. For the first time, generic pharmaceutical companies are also included in this mandate; branded companies feel that this is long overdue. [Read more…]