ing the regulatory agency’s thinking, which is something RA brings
to table, marketing will be able to
develop the most efficient strategy
that considers every regulation
hurdle early in the process. The approach is key to the management
of;expectations;and;the;achieve-ment of realistic results.
relationship! Marketing tends to
view RA as an obstacle in being
able to speak freely and creatively,
especially regarding competitors
and their claims. At other times,
they like when regulatory can help
craft claims and statements that
can be a competitive advantage.
They also appreciate it when RA
can inform regulators about competitors’ claims
What improvements could be
made in communications between regulatory and marketing
that would help in more effective
marketing and raise fewer red
flags with the FDA?
need to understand the others’
before deadlines is essential.
ROBERT GUZMAN: In a phrase,
“bring them early in the process.”
of my peers is that the regulatory
function is not brought into the
picture early enough. Sometimes
mitments have been made. Then
surprise when regulatory issues
function should not be seeing as
another functional step to achieve
a regulatory approval. It is a com-
plete strategy by itself and must be
taken into account as part of the
the strategy is laid focusing on
what is necessary for testing, clini-
cal, and other approval activities.
other marketing areas, such as how
off-labeling issues will be man-
aged, speaker engagements, and
claims substantiation, and where
there has been a lot of governmen-
tal interest lately.
LISA GRANEY: I agree. Early
planning. At the beginning of new
sales and marketing know what
they want to say about the product
– what they want to be able to say