FDA likely wins the award as the #1 speech regulator within the federal government.  It routinely censors speech by drug companies and others without regard to whether the speech is truthful.  Yet despite having lost several significant First Amendment lawsuits, FDA has been surprisingly effective in avoiding major constitutional challenges to its censorship policies.  FDA’s ability to avoid such challenges may have come to an end thanks to a criminal appeal pending in the U.S. Court of Appeals for the Second Circuit, U.S. v. Caronia.  WLF recently filed an amicus curiae brief in the appeals court in support of the defendant.

FDA’s First Amendment-avoidance strategy began a decade ago after it lost Washington Legal Foundation v. Friedman, a First Amendment case that resulted in a permanent injunction against FDA efforts to stop manufacturer dissemination of peer-reviewed medical literature.  FDA realized that courts would resist its efforts to impose direct bans on truthful speech.  So FDA began claiming that while it would no longer impose such bans, it remained free to use such speech as evidence of illegal commercial activity.  Thus, manufacturer speech about off-label uses of an FDA-approved product could be used as evidence that: (1) the manufacturer intended to market its product for an unapproved new use; and (2) the product was “misbranded” because its label did not include adequate directions for the intended off-label use.  In the ensuing years, a number of courts bought into FDA’s theory that such evidentiary use of truthful speech did not amount to regulation of speech and thus did not implicate the First Amendment.

The Caronia case may change all that.  Al Caronia was a young salesman for a drug company.  Prosecutors alleged that a doctor who was being paid a retainer by the drug company was touting off-label uses of Xyrem (one of the company’s drugs) in his conversations with other doctors, and that Caronia assisted the doctor.  FDA did not allege that the off-label information was in any way inaccurate (indeed, the uses being discussed were soon thereafter approved by FDA) or that any patients were injured.  A jury nonetheless convicted Caronia of conspiring to misbrand Xyrem.  Prosecutors made no effort to demonstrate that the labeling for Xyrem was inadequate for the off-label uses being discussed; rather, they alleged that any off-label communications automatically misbranded Xyrem.

In appealing his conviction to the Second Circuit, Caronia is relying heavily on a First Amendment claim.  It’s hard to see how FDA can avoid facing that claim head-on.  The only basis for FDA’s misbranding claim is that Caronia spoke truthfully to doctors about off-label uses for Xyrem.  And it made no separate effort to demonstrate that Xyrem bore inadequate labeling (and thus was misbranded); rather, it simply asserted that Caronia’s off-label promotional activity automatically rendered Xyrem misbranded.  No amount of constitutional gymnastics by FDA will allow it avoid the obvious conclusion: Caronia has been convicted of a crime based solely on his truthful speech.

If the Second Circuit decides to address Caronia’s First Amendment claims directly, the federal government will have a difficult time justifying its speech suppression.  It will need to show that its censorship directly advances a substantial government interest and does so in a narrowly tailored manner.  No such government interest readily comes to mind.  FDA occasionally speaks of its interest in suppressing truthful off-label speech as a means of encouraging manufacturers to expend the resources necessary to obtain FDA approval to label its products for new uses.  But that interest has little application in Caronia’s case:  the manufacturer had already sought FDA approval for the new uses at issue.  FDA’s real motivation has long been readily apparent: it does not like manufacturers providing information about their medical products until after FDA has certified that the information is truthful.  But the First Amendment doesn’t work that way – unless the government has reason to think that commercial speech is false, the Constitution generally prohibits speech suppression.