What is "Truthful and Non-misleading?" That is the Question FDA Must Answer to Allow Off-Label Communications by Pharma

Yesterday, I attended and presented at FDA's Public Hearing on drug company communications regarding unapproved uses of drugs. My presentation had to do with off-label promotion directed at consumers and patients (find it here on Slideshare).

Just a few takeaways.

The phrase "truthful and non-misleading" was mentioned several times during the meeting, including by PhRMA (read "BIO #Pharma Industry Offers Its Own Set of Off-Label Communications Principles") and the Washington Legal Foundation (WLF).

In its testimony (here), the WLF said:

"Starting in the late 1990s with the Washington Legal Foundation cases, courts have consistently upheld corporations’ and their representatives’ First Amendment rights to communicate truthfully and non-misleadingly about the effects of their products. Courts have held that such a right is not limited by FDA approval of the use that is under discussion. Rather, the limiting factor on a company’s speech is a classic First Amendment test: whether the communication is false or misleading. Therefore, the FDA may only restrict health care companies’ speech regarding both approved and off-label uses if it is untrue or misleading to the listener. This test is grounded in both the Constitution and sound public policy. Pharmaceutical and medical device companies and their representatives possess the same rights to free speech under the First Amendment as other individuals, and patient care is strengthened by increased access to truthful information and innovation regardless of its origins." 

But defining what is true and non-misleading is difficult as many presenters noted.

Something can be truthful but also misleading as pointed out by Dr. Aaron Kesselheim, Associate Professor of Medicine, Harvard Medical School/Brigham and Women's Hospital.

Dr. Kesselheim used the Amarin off-label court case as an example. Kesselheim said that Amarin’s argument was “faulty, because the so-called ‘truthful and non-misleading’ statement is a tautology.” Amarin was telling doctors this about its fish oil product:

“Supportive but not conclusive research shows that consumption of EPA [acid eicosapentaenoic acid] and DHA [docosahexaenoic acid] omega-3 fatty acids may reduce the risk of coronary heart disease.”

The CHD benefit is not part of the official, FDA-approved labeling for the drug.

“All this qualification really ‘says’ is that non-conclusive research has been conducted, but then the second half of the claim expresses nothing at all about the clinical import of that research,” said Kesselheim who illustrated the problem by slightly rewording Amarin's statement so it would NOT be misleading:

“Supportive but not conclusive research shows that consumption of EPA [acid eicosapentaenoic acid] and DHA [docosahexaenoic acid] omega-3 fatty acids may or may not reduce the risk of coronary heart disease.”

For more on this read "Harvard Professors Diss Off-Label #Pharma Free Speech as Non-Scientific").
There were other seemingly simple terms that presenters wanted the FDA to better define. For example, what does FDA mean by "advertising?"

Zoe Dunn of Hale Advisors was in favor of Direct-to-Consumer (DTC) off-label "communications" as long as they were not "Promotional." But where is the bright red line between promotional and non-promotional when a for-profit drug company is communicating with potential users of its products?

I'll publish a more detailed synopsis of presentations made at this meeting in a few days. Meanwhile, here is the Twitter #FDAofflabel timeline, which is focused on the the hearing and the issue of off-label drug promotion:

#FDAofflabel Tweets