Pain Points
- Mid-sized specialty pharmaceutical company received six warning letters in a four-year span from the FDA as a result of a highly ineffective process to approve promotional materials internally
- Communication and interaction between various Marketing groups and the Medical, Legal and Regulatory departments was strained
- A new promotional materials management process was designed by an outside vendor but had not yet been implemented
- New process rollout also coincided with the rollout of a new customized IT system built for the review and approval of promotional materials
- High anxiety was present at the organization as a result of the departure from the “old way” of approving promotional materials
Our Solution
- Cross-functional key change agent “Champions” team was identified and assembled to ensure the new process was followed within their respective business groups
- Performed resourcing analysis and recommended additional Commercial Operations department headcount
- Communications Strategy and Plan were developed
- Initiative logo and tagline were created and embedded in marketing vehicles to create awareness internally
- Stakeholders were identified to assist with the dissemination of targeted messages coming out of the Communications Plan
- Team-building events were coordinated to optimize the new process and improve the organizational dynamics of the promotional materials reviewing teams
- A reward program was established to recognize high performers and reinforce positive behaviors
Benefits Realized
- Champions team structure put in place was “highly effective and helped enormously in circulating clear, properly branded messages” that highlighted the new process benefits and ensured two-way communication and feedback
- Role clarity, improved personal relations, team-work and communication between the Medical, Legal, Marketing and Regulatory departments “made a big difference in improving the quality of the submissions”
- Promotional materials were managed more “smoothly and efficiently” resulting in less issues down the line
- Adoption of the new process resulted in “quantifiable improvements to process metrics and palpable improvements in the culture”
- Number of warning letters from the FDA was significantly reduced to zero throughout the four years following the implementation of the new promotional materials management process
