Many pharmaceutical industry watchers believe the FDA can be a barrier to industry information. In any number of cases over the years, the FDA has helped clarify various pieces of a rumor and expedite our client's critical decisions. In one instance, a client heard that FDA had concerns about a drug's particular side effects, which could ultimately delay the release of the product.

By contacting the committee chair at FDA, we learned that side effects were of minimal concern, while the primary concern related to both dosing regimens and potential reactions to other medications.

Benefits and implications

This information not only dispelled the rumor, but also gave our client insight in a totally different – but critical – area. Product labeling concerns were addressed early on, and potential delays were avoided.