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People Who Live In Glass Houses....

By James M. Beck and Mark Herrmann

There's already been lots posted about the FDA's "Transparency Initiative" elsewhere, so we won't go into any depth at this point - we're litigators, not regulatory types.  We'd just like our viewers to note that many of the FDA's 21 proposals could have significant litigation effects.

For example, number 1 could result in a searchable database of anecdotal adverse event reports that would allow plaintiffs' experts to generate "summary reports" - seemingly bearing the FDA's imprimatur - with the push of a few buttons (with no mention of segregating out litigation generated AERs).  There's supposed to be some sort of "disclaimer," but we question if it will be as strong as what the FDA said back in 1996:  "Accumulated ADE cases may not be used to calculate incidences or estimates of drug risk."

Nos. 8 & 10 would provide public information of all pending investigational and marketing applications, including "intended uses."  This includes ANDAs.  Everyone's competitors would then know what's in the pipeline and would be able to throw spanners in the works.  If you think the pioneer/generic wars are bad now, imagine how they'll be when everyone knows exactly what applications are pending for what.

With every FDA regulatory letter (No. 21), inspection report (No. 6), and adverse application decision (Nos. 13-15) becoming instantly public, imagine the new litigation solicitation opportunities available to the other side (expanding to anything that goes wrong during clinical trials, for one thing).

The FDA also wants to create broad "public health" and "correct misleading information" exceptions to the confidentiality of summary safety and effectiveness data in pending applications (No. 16).  So if the FDA thinks regulated person has said something "misleading," it will now be in a position to impose the punishment of releasing that person's confidential data.  Great chilling effect, that.  FDA even wants to talk about releasing "non-summary" data - that's right, raw research data - from pending applications (No. 17).

Fortunately, there's a 60-day comment period before any of this can move ahead.  Anybody who has comments - and we can't imagine any FDA regulated manufacturer, importer, or participant in clinical trials who isn't threatened in some way by this - be sure to get them in by July 20, 2010.

Full post as published by Drug and Device Law on May 21, 2010 (boomark / email).