OFF-LABEL PROMOTION: WHEN PREEMPTORS THINK "SECOND-GUESSING" THE FDA IS A GREAT IDEA

On FDA Preemption and Off-Label Promotion

As many here will know, the most vociferous defenders of FDA preemption have also been the most vociferous critics of limiting off-label promotion. As replayed in a recent exchange on the Drug and Device Law blog, the argument is that a strong FDA is good (and should trump all civil liability), but not one that interferes with "constitutional right of private speech." So state courts and plaintiffs can't "second-guess" the FDA, but off-label promoters are free to do so.

Now, on one level, I'm not sure when speech becomes "private." I suppose the crowded theater is not such a place. How about off-label promotion to representatives of Medicare or the Army? Private or public? And what difference does it make, Constitutionally, if the off-label promotion is knowingly miseleading or outright false--as was alleged in the recent Pfizer cases?

These are real questions. For example, Holocaust denial is protected by the Constitution in the U.S., although not in other countries. So how about risk denial or benefit inflation, if engaged in by a company? Does it matter if the consequence of such misinformation may be, not "only" racist hatred, but prescribing that leads to deaths or injuries that would not have otherwise occurred?

Or is all of that a separate issue--if "private speech" can be proven to be associated with death or injury, one may suffer consequences--civil or criminal. Be that as it may, however, it is protected by the Constitution. Just as is one's right to risk civil or criminal prosecution--not for the "private" (if fraudulent) speech itself--but for its alleged consequences.


What do you all think?