11 - 12 September 2017 | Boston, MA

Thursday, December 08, 2016

2016 Sees a Slight Uptick in FDA’s Enforcement Actions

UPDATED 28 December 2016: On December 21, 2016, FDA issued two new Untitled letters for a total of 11 letters in 2016. Is FDA getting it's last licks in? More about that here.

UPDATED 15 December 2016: A few days ago, I reported that FDA continues to issue fewer and fewer warning and untitled letters. When I wrote that (8 December 2016) FDA had issued only 5 enforcement letters (4 untitled and 1 warning letter) compared to 9 letters in 2015.

This week on 12 and 13 December, FDA issued 4 new letters - 2 warning letters and 2 untitled letters - to bring the total to 9 letters for 2016. As the revised chart on the left shows, this equals the number of total letters FDA sent last year but this year, to date, FDA issued one more warning letter than it did last year. So, this could be considered a "slight uptick" in enforcement actions since warning letters are more serious than untitled letters, although the additional warning letter involved the promotion of a surgical irrigation solution promoted by United-Guardian via email to healthcare professionals.

Perhaps FDA is clearing its backlog and approving letters to be sent before the Trump regime takes over. That is, 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 (read this).

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