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Beck & Herrmann on Allergan suit for the right to promote off-label

Michael Krauss recently summarized the interesting suit by drug maker Allergan contesting, on First Amendment grounds, the FDA's ban on truthful off-label marketing of approved pharmaceuticals. Beck and Herrmann at Drug and Device Law have much to say about the suit as well:

One area where the First Amendment issue hasn't come up is in the various civil prosecutions of drug companies that state the DoJ, AGs (either "attorneys general" or "aspiring governors" - take your pick) or qui tam plaintiffs have brought concerning alleged off-label promotion in recent years. Why? One obvious reason is that big cases tend to settle because defendants generally are risk averse (this is the same reasons that certifying class actions leads to heavy settlement pressure). Another reason, more relevant to what we're discussing is that the First Amendment is something of a doomday defense, and regulated companies are reluctant to take on their regulator that directly. Regulated entities, rightly or wrongly, fear agency retaliation if they raise a defense with the potential of upsetting the entire regulatory applecart.

Though long (by blog standards!) and detailed, the post will be of interest to a wide variety of readers interested in commercial-speech doctrine, pharmaceutical law or regulatory practice.

More: They have an Oct. 13 update.

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Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.