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 atFDA ' 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 ithere 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" ). 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 illus...
Source: Pharma Marketing Blog - Category: Pharmaceuticals Tags: FDA off-label promotion Source Type: blogs