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Just when you thought the FDA was finished issuing Warning and Untitled letters for 2016, it issued 2 more – both Untitled letters – last week, bringing the total issued in December to 6! The grand total to date is 11 letters, including 3 Warning letters.
I suspect FDA is responding to critical posts such as the one I wrote on 8 December 2016 citing a total of only 8 letters up until that date. A week later I had to update that (here) when the total reached 9 letters for 2016. I characterized that as a “slight uptick” in enforcement compared to 2015 when FDA also issued 9 total letters because there was one more Warning letter (3) in 2016 than in 2015.
That additional warning letter involved the promotion of a surgical irrigation solution promoted via email to healthcare professionals, which I don’t put in the same category as warning letters involving drugs that are ingested by consumers. I would also note that 2 of the untitled letters were severely criticized for arbitrarily citing a trivial issue (read, for example, “‘Judge, Jury and Executioner. Nice System,’ says Bob Ehrlich Sarcastically About Recent FDA Enforcement Actions“).
The two additional letters also do not have the same level of importance as letters typically issued by the FDA. Read on to learn why.
One video, titled “Experts Discuss New Advances in Acromegaly”, for a drug by Chiasma, Inc., a U.S. privately-held biopharma company, was viewed a staggering 268 times! The other, titled “Saroglitazar Lipaglyn Mechanism of Action”, for a drug by Zydus Discovery DMCC, was viewed 11 times!
The URLs provided by FDA in the letters (https://www.youtube.com/watch?v=FCOLhuls3M and https://www.youtube.com/watch?v=TzmktzSo0u4) no longer link to the videos. The Youtube videos I found seem to have been posted by third parties; i.e., “MultiVu” and “Muzefer Abdulla”, whoever they are. See the image below for screen shots.
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I’m not going to get into the regulatory details. You can access the letters on FDA’s site here and delve into the details.
There are several reasons why I think the FDA is dredging the bottom of the barrel so that it doesn’t appear to be lax on enforcement:
- As mentioned above, these latest letters concern drugs not yet on the market.
- The videos I found received virtually no views! FDA, however, mentions that the acromegaly video also appeared on the Chiasma website.
- One video (Acromegaly) was published nearly 2 years ago on March 5, 2015. The other was published more recently on October 6, 2016. Seems FDA went trolling to find these so that it could up the number of enforcement letters before the 2016 clock ran out!