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Crisis Management Experience
A large company was alerted to patient reports of an emerging pattern of rare adverse events that was picked up by broadcast journalists. The events were noted in the development studies and spontaneous reports and recorded in the PSUR, but the impact on patients had not been appreciated to be as significant as was now being reported.
Initially the company restated its position and the fact that there was no question that the benefit risk for the product remained positive. Nevertheless pressure from the media for the company to acknowledge and take action continued to grow. As a result of media interest and lobbying, the regulatory agency decided to act and queried the company's position. Both the company and the regulatory agency were asked questions in the media.
Although a proactive media strategy was implemented, because of the difficulty in engaging with the public, a positive outcome was always going to be difficult to achieve. In this case reputational damage limitation was the objective. Nevetheless the company spent a significant amount of time reviewing and evaluating its pharmacovigilance database, to ensure that the labelling was as up to date and helpful as possible for prescribers and patients. In addition the company negotiated appropriate Risk Management and Minimisation plans with the Regulatory Agency, as well as observational studies to further follow up and characterise the real life experiences of patients.
Demonstrating the company's willingness to engage and take seriously the concerns of patients, and subsequently regulatory bodies, went some way to manage this product crisis. Crises can arise and evolve rapidly. Having people with crisis management experience is essential to work through and engage multiple functions in the organisation. This allows the company to take the issue seriously, and be seen to be doing so.
Please contact us for a discussion of how our Crisis Management experience can anticipate issues and work to avoid them.