A Marathon Pharmaceuticals LLC executive may have stepped awfully close to, or perhaps even over, a regulatory line when describing to patients how its newly approved Emflaza may be prescribed and offering help with reimbursement. It may have been advantageous for the company to inform patients that physicians still could prescribe the drug off-label for patients not included in the current indication, but it also may have opened the door to FDA scrutiny for potentially violating promotion rules.
The incident raises a number of questions about how pharmaceutical companies can operate in the age of increased and sometimes...
