Both Paul Howard and Charles Hooper have commented recently on the $3 billion payment that Glaxo was forced to cough up to settle charges of off-label promotion. I'm not familiar with the specifics of the Glaxo case, but I thought I'd add my two cents on the constitutionality issue that Paul and Charles raise.
It is true there are good reasons to believe that FDA's prohibition on off-label promotion is unconstitutionally over-broad. The U.S. Seventh Circuit Court of Appeals suggested in one recent case that the off-label promotion ban was "unconstitutional in at least some applications." But unlike Prof. Ralph Hall, I'm not optimistic about the U.S. v. Caronia case now being decided by the Second Circuit.
For one thing, Caronia presents what we lawyers would call "bad facts." Drug sales rep Alfred Caronia was prosecuted for participating in a face-to-face sales meeting in which Caronia's colleague told a physician about various off-label uses, but did not supply any scientific research supporting the safety and efficacy of those uses. Although we First Amendment purists might argue that even this kind of speech ought to be permitted, it's not a stretch for federal courts to justify restrictions on that kind of off-label promotion given current commercial speech case law.
Federal judges are more willing to find First Amendment protection when the speech involves distribution of published research findings or discussions of on-going research at scientific conferences. But in the Caronia case, a federal trial court judge has already held that a ban on the kind of promotion at issue could be justified because "some control over the off-label promotion of manufacturers does appear essential to maintaining the integrity of the FDA's new drug approval process." So, it's entirely plausible that the Second Circuit could agree that the off-label promotion ban is "unconstitutional in at least some applications" but constitutional as applied to Alfred Caronia.
In addition, the Caronia case also presents a couple of purely procedural issues that might permit the Second Circuit to reverse Caronia's conviction without having to reach the merits of the constitutional question. As it turns out, the FDA has been fairly successful in avoiding unambiguous court decisions on the First Amendment question, as it did in an earlier case litigated by the Washington Legal Foundation.
In that case, the federal District Court for the District of Columbia held that the off-label promotion ban was unconstitutional as applied to the distribution of peer reviewed medical journal articles. But the FDA changed its interpretation of the statute when it appealed to the DC Circuit, as I discuss in this article, thereby mooting the constitutional question and rendering the district court's decision invalid.
Similarly, after the biotech company Allergan sued in October 2009 for a declaratory judgment that the FDA's off-label promotion ban was "unconstitutional and inconsistent with the Food, Drug and Cosmetics Act," the FDA initiated a criminal case against Allergan for illegal off-label promotion. When Allergan settled in September 2010, it was forced to drop the constitutional challenge as a condition of the settlement.
Last month, however, yet another drug firm, Par Pharmaceutical, filed an almost identical action seeking a declaratory judgment that certain forms of off-label promotion were indeed protected by the First Amendment. With some luck, that case will actually be fully litigated, and we'll finally get a clean decision on the constitutionality of FDA's off-label promotion ban.
You can read more about my own thoughts on the constitutionality question here.