The FDA Breaks the Rules and the Law
9th November 2011
I said it won’t work and now it’s illegal, a consideration I hadn’t considered! One way or the other, those sincere persuaders at the FDA miss the mark and can blame their failed persuasion on somebody else . . . maybe the bankers. Yeah. The bankers did it.
Recall the FDA’s new warning labels for cigarette packaging. Here’s a shot to refresh your memory.
If you know anything about persuasion, theoretic or applied, you know that warning labels are not the Magic Bullets the health and medical community so adores. They are as likely to elicit reactance as they are to get favorable Central Route attitude change with the attendant and opposite potential outcomes. If You Can’t Succeed, Don’t Try . . . or else join the FDA. Now, there’s another reason the new labels won’t succeed.
They’re probably illegal.
The court blocked the Food and Drug Administration from requiring cigarette makers to put large, graphical warning labels on their packaging. The mandate likely violates the tobacco industry’s First Amendment rights, the court said.
Annoying nitpicker that he is, the judge cites numerous legal standards in this case, none of which it appears anyone at the FDA knew about.
The tobacco warnings don’t meet any of those standards, Judge Richard Leon said. He said the warnings are clearly an appeal to emotion, rather than a cold, factual communication. Arguments in the lawsuit clearly suggest that “the Government’s actual purpose is not to inform, but rather to advocate a change in consumer behavior,” Leon said in his ruling.
You should read the ruling if you are serious about persuasion, science, and government. The judge stomps the FDA repeatedly on my Rule: All Bad Science Is Persuasive. He reveals the twisted dynamic science and persuasion can create. Zealots will bend outcomes to fit existing biases and not seek arguments then follow them dispassionately to conclusion. He also proves a warning I offered a long time ago about those enraptured with the Nudge: What happens when you mix persuasion plays into rule, regulation, or law? This judge deems it likely illegal.
You may have noted my qualifiers of “probably illegal” and “likely illegal.” It stems not from any problems in the judge’s finding, but from the legal strategy the tobacco companies are pursuing. They have two cases. The first, this one, sought, and received now, an injunction to delay the FDA implementation. The second, still pending, is on the merits of the FDA’s actions. The injunction seeks to avoid immediate harm while the second case seeks a judgment on the legality of the FDA’s actions. For the injunction, the judge has only to make a ruling about the likelihood the tobacco companies can succeed in the other case. He provides reasoning and evidence to suggest that, yes indeed, the FDA has serious legal problems.
Of course this judge is a tool of the tobacco interests or a tool of the conservative right or just a tool, except . . .
Finally, as part of its preliminary benefits analysis, the FDA estimated that “the U.S. smoking rate will decrease by 0.212 percentage points” as a result of the Proposed Rule,9 75 Fed. Reg. 69,543 (emphasis added), a statistic the FDA admits is “in general not statistically distinguishable from zero.”
The FDA computes that their new warning label regime will reduce smoking by 0.212 percentage points. Three decimal accuracy! But not SSD! Even if the judge is a tool, consider that factual disclosure from the FDA in court. How can you think like this and call yourself reasonable, much less scientific? Your own scientists offer an officiously precise and truly trivial effect size, note that it would probably not be SSD, yet still think they’ve done the job as ordered by Congress?
Many tobacco control advocates see Big Tobacco as Big Evil. In so characterizing, these advocates blind themselves to the law of Laws and the rule of the Rules. The political appointees from the Obama Administration running the FDA hate tobacco companies so much that considerations of competence and Constitutionality are not only irrelevant, but ignored.
P.S. The FDA needs to hire either those Berkeley physicists or the Harvard epidemiologists on making 0.212 percentage points SSD. It’s easier than you think and when you’ve got the Fed’s printing press, money isn’t a problem.