FDA ’s Lax Enforcement Trend Continues

FDA continues to issue fewer and fewer warning and untitled letters. As of today (8 December 2016) FDA has issued only 5 enforcement letters (4 untitled and 1 warning letter) compared to 9 letters in 2015.Perhaps in 2017 FDA will issue no letters at all, especially if Trump has his way and Silicon Valley investor Jim O ’Neill becomes the new FDA Commissioner. O’Neill is not a scientist or physician so it ' s no wonder that he has proposed that the FDA only require companies to prove drugs are safe before they are sold – not that they actually work (readthis).The other trend I see is FDA caving in to forces that oppose limiting the drug industry to promote drugs off label. For more on that issue, readthese articles.Why Donald Trump ' s Putative FDA Pick Should Scare Pharma& Patients
Source: Pharma Marketing Blog - Category: Pharmaceuticals Tags: FDA warning letters Source Type: blogs