There are two kinds of risks associated with a drug product. First, those we don’t yet know about, but which manifest once the drug gets on the market. Second, are those we do know about but can avoid or minimize risk through effective communications.
For example, Rezulin – a diabetes drug approved in January, 1997, was known to have some hepatic risks associated with its use. Risk management efforts were put into place, but they were so unevenly applied, that the risk was not minimized – people continued to suffer liver injury. That begs the question – are we failing to effectively communicate or are there other issues that need to be addressed?
This was a question posed by Dr. Scott Gottlieb this summer in a speech before the American Medical Association when he cautioned against the growing desire for the FDA to get involved in the practice of medicine with the physician. "…I worry about the future. My concern is that even though we do not have the legal authority to impose these plans on drug sponsors, they are nonetheless becoming an increasingly prominent condition of certain approvals as we negotiate final labeling over newly approved drugs. It is fair to say, I believe, that these plans are sometimes a less-than-optimal response to more systemic systems problems in the delivery of medical care."
Dr. Gottlieb points out that these plans become an enormous cumulative burden and expresses hope that they don’t become part of the mandate of the agency, suggesting instead other ways for the agency to address risk.
But in the post-COX-2 environment, it is difficult to see a future that doesn’t have the FDA more involved in risk management plans and requiring such plans of companies as a condition to drug approval. To that end, the communications firms that support these companies need to come to the table with more than the traditional offering. They will need to supply greater substance and research to support their communications counsel.
That means that there needs to be greater attention paid to research into human behaviors and communications. As we have put some effort over the years into understanding how to reach a specific demographic with a message that motivates, similar effort has to go into the examination of language and how it can best motivate and direct behavior of both physicians and patients.
What that means in the practical sense is to bring in experts in both psychology and linguistics – those who have done studies and can recommend language and interventions that are going to maximize success. Where are these people? They are in good universities – they are members and former members of the FDA’s Drug Safety and Risk Management Advisory Committee.
In preparation for the future, communications firms would be well advised to add these types of resources in their healthcare practices because even though I think Dr. Gottlieb is right about the role of these plans, I think the environment will dictate otherwise, and when it does, communications firms will have to provide the resources to work successfully with clients bringing new products to market.