It all sounds so simple. But, it’s anything but.

Another example of why lawyers should keep their noses out of healthcare and technology. Because their knowledge is about as comprehensive as a high schooler’s. Which is probably the last time they undertook studying the subjects. (I wrote about this before … Britain determined that lawyers and judges needed to have better understanding of neuroscience, so it is now providing annual courses. America should do the same- including all of science, technology, and medicine.)

So, what’s got me going? Judge Paul A. Englemayer, presiding at the Southern District of New York, just ruled against the FDA (and for Amarin Phama, Inc.). His decision means that off-label uses for drugs may not be regulated, since the judge considers it an infringement on free speech- a violation of Amarin Pharma’s Fist Amendment rights. Interestingly, Amarin is NOT an American entity. (Before we get too far in to this discussion, I’m betting the FDA will appeal. )

Until this court case, the FDA clamped down on marketing drugs for off-label use. (‘Off-label’ means these “benefits” have not been adjudicated and can’t be listed on the label .   [Take this drug when you have xyz, is a “labeled” claim.])  That practice means that only those claims for which the drug has been submitted to the FDA and has approved may be advertised by manufacturers and marketers. Any other use- one not approved by the FDA (the ‘off-label’ claim)- was a forbidden act under the FDA regulations. (To be honest, this practice is often breached.) And, I will admit that Englemayer stipulated that those off-labeladvertisements have to be truthful. (I’ll get to this non-sequitur soon enough.)

What this ruling means- until it is appealed (and presumably reversed)- is that the FDA will now have to rewrite several regulations and change the oversight system that has been in place for decades. The FDA has claimed (since June 2014) that a new guidance document that would control how medical products could be promoted was in the works. But, no one has seen a page of this document yet.

Now, why is this judicial decision wrong?

Let’s say, a slew of off-label uses have been tested. And, of these mutliple studies, two sets of results demonstrate the potential use may have merit. But, five of them don’t. And, the manufacturer elects to promote the off-label use only quoting the two studies in its favor.

That situation is in total compliance with Englemeyer’s ruling. After all, the data they are presenting are true and verified. But, the odds are they are not correct- and, at the very least, they are subject to interpretation and further evaluation before we subject patients to these “benefits”.

Keep in mind, that thalidomide (the US physician at the FDA, Dr. Frances Kelsey, who worked hard to get thalidomide off our drugstore shelves died the same day this ruling was issued.) was invented (and approved) as a sleeping pill. But, when used as a cure for morning sickness, thousands of children were born with defects, missing limbs, and many more fetuses died before being born.

So, where’s their free speech?

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