THE CHALLENGE

A multinational pharmaceutical company with nearly $100 billion in sales submitted a supplemental NDA to the FDA to add a new indication for their most popular product. Understanding the importance of the FDA Advisory Committee review to their global franchise and the potential for adverse messaging, as well as millions of dollars riding on the outcome, the company hired ISS to assist in the management of the Advisory Committee review.

 

THE ISS SOLUTION

ISS has been involved in more FDA Advisory Committee meetings each year than even the biggest pharmaceutical companies. ISS was responsible for all aspects of the Advisory Committee process including: crafting key messages, honing presentations, creating and managing backup slides and retrieval, mock rehearsals, consultant engagement, and timeline and budget management. In addition, ISS handled all logistical elements for the program so the sponsor could focus on a successful advisory committee outcome.

 

THE RESULT

The client was given a unanimous vote of approval for the revised labeling and the removal of a controversial warning that had been added as part of an Early Communication by the FDA. Within weeks of the successful outcome, ISS was back at work for the client on its next blockbuster drug Advisory Committee review.