Life Science Compliance Update





FDA’s Meeting on Promotion – Can We Glimpse the Future?

Written by , Posted in Free Speech

Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

In November, the FDA held a two-day Town Hall meeting to allow for input from stakeholders and patients surrounding agency regulation of manufacturer communications regarding unapproved uses of drugs and medical devices. This article provides a brief summary of the two-day event, including several presenters and their opinions.





When They Don’t Have Anything, They’ll Try Anything

Written by , Posted in Abstract, Free Speech

By: James M. Beck, of counsel, Reed Smith LLP, Philadelphia, PA

In pharmaceutical litigation, the First Amendment provides a shield, but not a sword. Plaintiffs seeking to avoid preemption in generic drug product liability litigation are unlikely to be able to assert the defendant’s First Amendment “right” to provide truthful information because the preemptive aspect – FDA pre-review – is a reasonable “time, place and manner” regulation. Further, the “truth” of fully protected speech may not be decided in litigation.

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