Ruling in Big Pharma’s favor throws caution to the winds

The FDA may have just lost forever its ability to stop drug companies from selling you dangerous meds for conditions they were never meant to treat.

All thanks to a tiny company that most people have never heard of.

A New York federal judge has issued an injunction claiming that drug maker Amarin has a First Amendment right to claim whatever it wants about its products.

Even if those claims have never been approved by the FDA — and even if they might eventually harm you.

It’s not exactly what our founding fathers had in mind. But it may be the start of a dangerous and sleazy new chapter in prescription drug marketing — one where you’re going to have to depend on yourself to stay safe.

Measured in livesThe fight between Amarin and the FDA is over something called “off-label marketing,” where shady sales reps peddle drugs for unapproved uses.

It’s long been banned by the FDA — and for good reason. Over the years, drug companies have been caught red-handed selling drugs to treat cancer, epilepsy, psychological disorders, and dozens of other conditions for which they’d never been tested.

But the ability to sell meds based on nothing but speculation, sketchy research, and anecdotal claims — free from the prying eyes or regulations of Uncle Sam — is worth billions to Big Pharma.

And it looks like Amarin was fighting this battle with the FDA on behalf of the entire industry.

You see, Amarin isn’t some billion-dollar drug giant. It’s barely a gnat. The company lost $56 million last year and makes just one product — Vascepa, to treat high triglycerides.

So you’d think that when the FDA signaled that it was willing to settle the issue — which was about nothing more than Amarin’s desire to sell Vascepa to people with slightly lower triglyceride levels — Amarin would have bitten.

But it was clear from the start that the company wanted nothing less than a federal court order — one that could apply to the entire industry — declaring that drug sales reps have a Constitutional right to claim just about anything that pops into their heads.

Now that order has been issued and the floodgates are open. Any drug company in the world can now bully the FDA and claim the same “free speech” rights to market their drugs for untested — and potentially deadly — uses.

“The FDA and the Department of Justice are certainly on notice now as to what the law is in this area,” Floyd Abrams, a First Amendment attorney, told the Wall Street Journal.

When I first told you about this case a few months ago, I warned that a drug expert from Johns Hopkins claimed that if the FDA lost the consequences would be “measured in lives.”

But you don’t need to be the next victim of Big Pharma greed. Before you fill any prescription, read the labels and search online to see what the drug was really approved for.

Because nobody should have to take a pill based on a wink and a promise from a sales rep. Especially one who knows he’s lying.

Sources:

“Amarin case could unleash a flood of off-label promos” Tracy Staton, August 10, 2015, FiercePharma, fiercepharmamarketing.com

“Court sides against FDA in ‘off-label’ drug promotion case” Matthew Perrone, August 10, 2015, AP, host.madison.com