I think it must be reported to public authorities. Currently, under-reporting is said to be prevalent. The problem regarding post-market regulation is that expectations concerning self-regulation by pharmaceutical companies are much too high. Yet, through experience, we know that this mechanism works to a certain extent, but is very limited. In order to gain public trust, and guarantee accountability within the process, a neutral public authority must be responsible for regulation.
On April 29th, 2008. See this statement in context.