Tuesday, October 6, 2009


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?


  1. So, basically, the DDL boys want to keep the scales of justice out of balance.

  2. Heavens No, Donovan. They are fighting for the Constitution and for the welfare of all of us.

  3. "Every trick in the book, Baby..."

  4. If freedom of speech has no limit, maybe they’d like to allow people to yell “FIRE” at the movies, especially Michael Moore’s, especially when talking about Dead Peasants. See: http://www.youtube.com/watch?v=t4ZdgIk8f_o

  5. Um, I dunno. I'd assume that making false advertising claims about your product does not fall under the umbrella of "free speech". Would that be an incorrect assumption?

  6. If your product is a drug, one would hope so. That's why DTC, for example, is regulated.

    For most off-label promo cases, the issue is not knowing fraud (for which Pfizer was convicted), but promoting the unproven/unknown/unregulated. Thus, FDA has tried to find some zone in which limited such promotion is possible: e.g., making use of "peer-reviewed" journal articles, etc..

    Of course, if the journal article is itself spun, ghost-written by company, cherry-picked, etc......

    The defense lawyers do like to refer to "true" information. But in this world of ours...


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