Lots of people pay lip service to the First Amendment, and its importance to our democracy. But how many people actually understand it, let alone have any respect for it? And lack of understanding and respect for the First Amendment are particularly prevalent among those in positions of power and authority. Hey, what fun is power and authority if you can't shut up your critics?
One of my favorite Stalinist corners of the federal bureaucracy has long been the FDA, where they somehow think they have the absolute right to determine what can and cannot be said in this country about any substance that might ever cross human lips. First Amendment? What's that? The FDA first won my award for "Top federal effort to suppress free speech" back in 1999, for its long-running efforts to ban so-called off-label marketing of pharmaceuticals. Sixteen years and several tens of billions of phony fines collected from pharmaceutical companies for constitutionally-protected conduct later, the FDA was continuing to march forward undeterred in its campaign to ban off-label marketing, when suddenly last August it found itself enjoined from enforcing those restrictions against a company called Amarin. Amarin had sued in federal court seeking the injunction by asserting that the FDA could not point to anything false or misleading in its proposed marketing campaign; and a judge in the Southern District of New York (Engelmayer) agreed and issued the injunction.
At the time the FDA vowed to appeal, but yesterday comes news that they have backed down and settled with Amarin. Do you think that was decent of them? My take is the opposite: They were facing near certain crushing defeat in the Second Circuit; and by settling now they will continue to take the (outrageous and preposterous) position that their off-label marketing restrictions are still viable, and to attempt to continue to enforce those restrictions against others. From the Times article linked above:
The agency on Tuesday downplayed the implications of the deal. In a statement, it said that the settlement applied only to the Amarin case and that its position on whether companies have a constitutional right to provide truthful information about off-label uses had not changed.
Well, that's how much respect and understanding the FDA has for the First Amendment. How about some others quoted in the Times article? For example, there is Dr. Joshua M. Sharfstein:
Leaving such decisions to a judge, not the F.D.A., concerned Dr. Joshua M. Sharfstein, a former principal deputy commissioner at the F.D.A. who is now an associate dean at the Johns Hopkins Bloomberg School of Public Health. “The courts are at the precipice of taking over a fundamental F.D.A. function of calling balls and strikes in the drug market about what’s truthful and not misleading,” Dr. Sharfstein said.
Got that? According to ex-FDA "principal deputy commissioner" Sharfstein, it's a "fundamental function" of an executive agency of the government (here the FDA) to decide what you can and cannot say. And the courts just have no business meddling! Really, did this guy (or anybody else who now or ever has worked for the FDA) even go to high school?
Meanwhile, in the same category, there's another important case on off-label marketing that I haven't yet mentioned here. Justice has been prosecuting a guy named Howard Root, CEO of a company called Vascular Solutions, Inc., for supposed off-label marketing of a device called Vari-Lase for the treatment of varicose veins. Root took his case to trial, with the full support of his company and his board, and in February a federal jury in San Antonio, Texas acquitted him of all charges. A lawyer named Kevin Riach notes the significant aspect of the trial:
Notably, the trial court instructed the jury at the opening and close of trial that truthful off-label promotion is not a crime because such speech is protected by the First Amendment. This instruction marks the first time that the First Amendment protection for truthful off-label speech has been adopted by a court outside the Second Circuit, and it is a significant blow to the government’s ability to prosecute companies for off-label promotion. The court’s instructions are likely to be cited by other companies facing False Claims Act and criminal liability for off-label promotion in future cases.
And there's nothing like an acquittal to finally give a wrongly-accused defendant the ability to open up and unload against the outrageous and oppressive government. From a statement by Root after the verdict:
"The company and I are vindicated by today's verdict, but outraged by the obscene legal process we were forced to endure," Root said in a statement. "There is simply no excuse for abusive and dishonest conduct in any U.S. governmental agency, much less in the Department of Justice and our law enforcement agencies."
All I can say is, he was still a lot nicer than I would have been.
Anyway, the FDA is not giving up on this, but gradually the fissures are opening.