The third big piece of news this week in the area of Phony Prosecutions came on Friday from Southern District of New York Judge Paul Engelmayer. The good judge enjoined -- yes, enjoined -- the FDA from enforcing its so-called "off-label marketing" restrictions against a company called Amarin and its drug Vascepa. Here is a copy of Judge Engelmayer's decision. The injunction is preliminary, so the case will continue. However, Judge Engelmayer took the time to write up a very careful 71 page decision. This one may actually throw the FDA back on its heels.
I have previously covered the subject of the FDA's so-called "off-label marketing" restrictions here. That article, back in 2012, reported on the Second Circuit's then-new decision reversing on First Amendment grounds the criminal conviction of a guy named Caronia for promoting a drug for uses that had not been specifically approved by the FDA. Yes, the poor guy had to suffer years in criminal prosecution hell and a conviction in order to vindicate First Amendment rights that should have been obvious to everybody. My 2012 article also linked to an article I wrote way back in 1999, called "Top Ten Federal Government Efforts To Suppress Free Speech." The 1999 article gave the number one ranking to the FDA's restrictions on off-label marketing of drugs that had been approved as safe and effective. Here are some of my prescient words:
No agency can top the FDA when it comes to imposing bureaucratic control over free speech, even at the expense of human life. The FDA believes it has an absolute veto power over all speech concerning anything consumed by human beings. . . . On February 16, 1999, after years of litigation, Judge Royce Lamberth of the U.S. District Court of the District of Columbia enjoined [a] particular [FDA] rule as contrary to the First Amendment, and ordered that the FDA could not prevent manufacturers from circulating articles just because they described new uses of a drug that the FDA had not yet approved. But Judge Lamberth's decision is just one small victory against the FDA's massive efforts at speech suppression. Even as a few formerly suppressed articles begin circulating, the FDA wages an aggressive, multi-front campaign to regulate and squash prescription drug advertising. . . . The agency may lose in court in the end, but the FDA is unlikely to learn from yet another defeat in court and does not appear willing to curtail what it views as the righteous fight to suppress free speech. Do the bureaucrats at the FDA have any idea what the United States is all about?
We are now sixteen years past that article, and the FDA just keeps fighting pitched battle after pitched battle to preserve its bureaucratic privileges. Amarin even went through the trouble of doing a big double-blind study to support the effectiveness of its drug for uses that had previously not been part of the initial FDA approval. But the FDA declined to "allow" Amarin to promote the results of the study. As in all matters that relate to off-label marketing, the FDA's bureaucratic position had nothing to do with safety or effectiveness of the drug, both of which had already been established. The FDA has a convoluted legal theory under its statute to claim the authority to prohibit the making of true statements about a drug whose safety and effectiveness have been established. Essentially, they call off-label marketing "misbranding" of the drug. Huh? There's no understanding it, other than that they view defending and enhancing their bureaucratic prerogatives as far more important than things like mere lives of patients or free speech.
With no legal leg to stand on, it is truly remarkable how long the FDA can keep this game going. Sadly, none of the big pharma companies are willing to challenge it. They all just cave. For that reason the decisions knocking down the FDA are few and far between, but meanwhile the FDA shakes down one pharma company after the next for what should be First Amendment-protected speech. Judge Englemayer's opinion lists some of the recent settlements (including criminal guilty pleas) and fines paid by the big guys in obeisance to the FDA: $1 billion paid, plus a criminal guilty plea, by GSK in 2012 for alleged "misbranding" relating to Paxil and Wellbutrin; $500 million paid by Abbott Labs in 2012 for alleged "misbranding" relating to Depakote; $375 million paid by Allergan in 2010 for alleged "misbranding" relating to Botox; and so forth. My 2012 article lists multiple others, including a settlement by Pfizer for over $1 billion. None of the big players will take a case to trial. Nor would any of them have brought the injunctive action that Amarin brought here. They have too much at stake, and the FDA can kill them in a thousand other ways on a thousand other issues if the company is perceived to have "dissed" the regulator. So it took one of the tiny players in the business (Amarin's 2014 sales were just $54 million) to pursue this case.
So how big is this decision? In my opinion, big. The FDA is going to lose in the end. Having written this big opinion, there's no way that Judge Engelmayer is going to change his mind after a trial on the merits for the permanent injunction. The Second Circuit? They're the people who reversed in Caronia.
But I wouldn't expect the big guys to start major off-label advertising campaigns any time soon. They're just too pusillanimous. Not that I blame them. It's going to take a series of victories by little guys following in Amarin's footsteps to slowly open the floodgates. Really, it's disgusting that that's how our government works. Keep this in mind next time you find yourself thinking that government regulators are just neutral, apolitical experts doing their best to protect the public.