From Snake Oil to Fish Oil. The Need for a New Approaches to Off-Label Communication

Yesterday the new Duke-Margolis Center for Health Policy (headed by Mark McClellan), held a conference titled, “Off Label Communication in 2016: Meeting Information Needs through New Policy Options.” Those new options are detailed in an important new paper: Policy Options for Off-Label Communication: Supporting Better Information, Better Evidence, and Better Care. Just about every speaker pointed to the need for FDA leadership – though bold action and … clarity. This is urgent for many reasons: different federal agencies (FDA, FTC, DOJ) with different views on pathways and jurisdiction, and the extreme danger of allowing federal judges dictate regulatory policy. If existing policy has evolved to protect the public from snake oil, the recent Amarin decision is precarious precedent for communications about fish oil – and beyond.
Source: drugwonks.com Blog - Category: Pharmaceuticals Source Type: blogs