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.

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