The Fable of Off-Label

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  • 12/11/2012

I am not one of those who in expressing opinions confine themselves to facts.

-- Mark Twain

What? Off-label communication is protected free speech?

Cry havoc and let slip the dogs of war!

Not so fast.

As Steve Usdin of BioCentury so aptly opines, the ruling is “far less consequential than media coverage suggests.”

According to Usdin:

… companies and individuals who take the decision as a signal that the rules of the road have changed and they are now free to promote off-label indications put themselves in great legal and economic peril, attorneys who helped persuade the court to overturn Caronia's conviction told BioCentury.

At the same time, the decision by one of the country's most influential and respected courts to overturn a criminal conviction on First Amendment grounds is persuasive evidence that, in the long term, FDA will have to change some of the assumptions underpinning its regulation of medical products.

FDA, which now has lost a string of First Amendment cases, cannot forever hold on to the notion that it is empowered to prohibit drug companies and their employees from saying things that anyone else is free to say. Sooner or later, according to legal experts, the agency will have to reconcile itself with the idea that industry has the right to truthful, non-misleading speech.

While change is inevitable, the pace of change is uncertain. It is also not clear who will shape that change - FDA employees, judges, or members of Congress.

In short the Caronia ruling didn’t really answer any questions so much as it opened up the conversation. And that alone is worth the price of admission.

What will it mean on the ground? In the short term, not much. But it’s not about instant gratification for aggressive marketers.

This ruling isn’t the beginning of the end of FDA warning letters on off-label communication -- but it very well may be the end of the beginning of such speech being off-limits to prudent corporate compliance officers.

Equally important, what will it mean for off-label conversations with patients and caregivers? What will it mean for regulated speech on social media?

As William Safire once said, “Is sloppiness in speech caused by ignorance or apathy? I don’t know and I don’t care.”

Usdin’s complete story, Free speech, in theory, can be found here.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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