Thursday, December 6, 2012

Did off-label promotion just become legal?

On Monday, a court in New York ruled free speech prevails over off-label discussions.

Wait. Whaaaaaat?

It was this news nugget that prompted friend and compliance/regulatory attorney Darshan Kulkarni of Kulkarni Law Firm to tweet this to me:

What happened? A summary

On Monday, a federal appeals court in New York threw out the conviction of a pharma sales rep for promoting off-label use of a prescription drug. The court found the sales rep’s First Amendment right to free speech had been violated. Judge Denny Chin wrote:
"In the fields of medicine and public health, where information can save lives, it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed.”
The ruling essentially follows the notion that "The more information available to everyone, the better. If physicians can discuss alternative uses of drugs, others should be able to do the same.”
So far, not surprisingly, FDA has not commented on the ruling.

Darshan and I co-presented in September on the topic of FDA's recent guidance, "Responding to Unsolictied Requests for Off-Label Information About Rx Drugs and Medical Devices." Back then, and to his credit, Darshan predicted this to happen, referencing the IMS Health v. Sorrell case where a Supreme Court decision stated the governement cannot limit free speech.

Interestingly, Darshan expects it's this sticky issue off-label promotion that is precisely the reason FDA is holding off on providing social media guidance. If off-label promotion is protected by free speech, then they have to go back and look at everything all over again.

“To be clear, this isn’t law of the land, just of that specific jurisdiction,” he wrote to me in a tweet Monday. It “will likely involve some negotiation. But (this) will have HUGE implications.”

[If Darshan, an attorney, were writing this blog he would insert some legal disclaimers here as reminders that this is not legal advice and this does not setup an attorney-client relationship :-) ]


What does it mean?

What does this mean for FDA? Essentially, they’re in a pickle. Forbes sums it up this way:
This appellate decision, if it stands in the long-run, forces the FDA into a corner. It must either grant greater leeway for pharmaceutical manufacturers to market off-label uses of their products or restrict the ability of doctors to prescribe medications for anything other than agency-approved uses, an approach it has been loath to take.”
I'm not a lawyer, but Darshan is. And he pointed out to me that this last part isn't exactly true. FDA can't regulate physicians' prescribing of medications because they are instead regulated at the state level - by the state Boards of Medicine. Either way, FDA is in a bit of a bind.

What does it mean for patients? That likely depends on whom you ask. Empowered, informed patients comfortable with their physician relationship and their/their doctors' decision-making abilities may welcome the opportunity for more free speech around alternative uses. There are many drugs that are regularly prescribed off-label, providing valuable treatment and relief. Of course, there is tremendous mistrust of this industry. Some patients understandably may not like the idea of pharma reps and marketers having a quintessential "free for all" when speaking around product use and safety. And some pharma company representatives may not handle this new freedom wisely or responsibly. It really comes down to who has the most influence and decision-making power in each pharma-physician-patient dynamic.

What does this mean for pharmaceutical companies today? Will it embolden them to begin regular and blatant off-label promotion? That's not likely, given the billions in settlements various companies have paid FDA for off-label promotion in recent years (though those settlements themselves may be called into question). Perhaps the aversion to risk will be somewhat lifted. But most likely, it will come down to how much a company stands to gain or lose. And again, if history is any indication, that could be billions.

If any change is to come from this, I expect it to be slow. It’s definitely something to keep an eye on. And this is just one court's decision. Future decisions for similar cases, as well as escalation to the Supreme Court, may further solidify the situation one way or the other.

It may eventually open up more ability for pharma companies to communicate about their products.

It may also just tie up any further FDA marketing guidance in a legal quagmire.

Additional headlines and perspectives

Special thanks to Darshan Kulkarni for his opinions and insights for this post. Visit his firm's website for information on how to contact him for more information, or reach him on Twitter at @FDALawyers.


Darshan Kulkarni said...

Hey Wendy, thanks for mentioning me. I would keep an eye out for the Scott Harkonen case currently happening in the 9th circuit which also tackles the issue of free speech and off-label discussions. It may concur with the Coronia decision or may instead disagree and cause a circuit split. If both courts agree (which seems likely because of the IMS v. Sorrell decision), the FDA will have to very seriously look at its official position on off-label advertising. Alternatively, we may be looking at one of 4 options:
1. An en banc hearing (9 circuit court judges rehear the Coronia decision)
2. Appeal to the Supreme Court
3. Circuit split (which can happen with the Harkonen case)
4. FDA agrees to abide by the decision of the 2nd Circuit.

Wendy Blackburn said...

Thank you for the tip, Darshan! Further proof that the issue is quite complicated and could take a number of different directions from here.

Inkjoy calligraphy said...

Interesting. Wonder why they made that decision.