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Good evening America! #Thread on the issues with ibuprofen & generic drugs in the U.S. (long)
Earlier this afternoon, we dropped a thread on the above topic that was very industry centric. Tonight we are going back through that thread and break it down for everyone.
This thread started with this opinion piece on foreign Pharma factories and what happens in them. nyti.ms/2Jihy9P The opinion piece is equal parts truth, common industry knowledge and a hard sell on the book.
The opinion piece and then our post completely caught the FDA on their heals. They have been trying to get out in front of the story all day but little success has been made in that area. We highly recommend you read the opinion piece. Seriously!
Now to our thread., in it we used a lot of industry terms. We will now repost the thread and explain each term as they come up.
“Now on to what we have done to protect American ppl. We have had a discussion with Scott G. about the largest manufacturer of ibuprofen in the world who also happens to be based in the US. The CoA data that has been compiled for years shows a blatant attempt at Dry Labbing.”
Scott G.- The former commissioner of the FDA. Who was replaced with Ned (Are you going to follow us Ned?).
CoA- Certificate of Analysis: The document that list all the scientific test performed on a drug and the results of those test.
CoA- Certificate of Analysis: The document that list all the scientific test performed on a drug and the results of those test.
Dry Lab (ing)- Writing down test results without actually doing the test.
The company that we are speaking of, produces generic and name brand ibuprofen for almost all the US market and a larger portion of the world. To say that this issue is huge and a shit Storm is an understatement.
“impurity results so exactly the same over a multi year slant that statistical models could not even begin to account for it. Here is what we said to Scott”
Impurity’s- Basically chemical compounds that should not be in the pill. Like high levels of lead.
Screen cap 1 of our Scott G. Convo. 
iLims- a FDA certified program used in the tracking of test results. This program can provide data to make product manufacturing adjustments that the FDA will recognize as non- corrupted.
SAP- an inventory/ work flow tracking program that can be FDA certified and also produce non-corrupted data. If the program is not of the certified level though, anyone can change any data at any time with no tracking of the changes.
Screen Cap 2-
Lab ware (Glassware)- Beakers and flask etc. used in the prep of the testing of the product. Having poor glassware often leads to erratic test results or other more sever issues.
Storage of test preparations- under a list of best practices that help a lab guarantee that you are not producing false results or mixing up old and new work. Having excessive amounts of tested material and test preps is a huge no no. It speaks 2 the culture of caring in a lab.
API- Active Pharma Ingredient. It’s what you see as the measured amount on a bottle. A 20mg ibuprofen tablet as an example. The rest of the tablet is filler like compressed sugar and a colour coating.
We have talked about before how having 2 matching test results for repetitive test is luck. Having 3 is something to look at and see if there is some skill there or something else. Having thousands of the same results over many years is criminal.
The size and scale that we are discussing here, would bankrupt the company in question and severely hurt the generics industry. That said, this is where we are by the the lack of FDA oversight and good company oversight.
Scotts reply to us:
“Where does this all stand now? We know said company has responded to the 8 483's twice now. The first reply was rejected. The second reply is still in review, with a good certainty of a warning letter to follow.”
483- a finding of wrong doing or issue that needs to be immediately addressed by the manufacturer. They also need to submit a plan to correct the issue and data proving that the issue did not affect any drugs.
Having 1, 483 is an issue. Having 8 makes ppl stop doing business with you and speaks directly to the work culture in the company and where their priorities are.
And having your reply sent back is another huge red flag. It either indicates that they don’t take the issues seriously or have the knowledge/ ability to properly address the issues. The FDA basically said “Try again... Harder”
A brief thought on our convo with Scott G. Scott has followed us from day 1 & made his views about us well known. @DonnaYoungDC has a great article on this topic. We have taken that and this extraordinary step to protect you. We are severely exposing ourselves for you in this.
What can You Do? 1- RT and like this tweet. 2- Demand that the FDA do better. 3- Demand laws that protect you better. 4- Do not loose faith in our drug verification system. It’s not perfect but it’s the best in the world.
-Dallas
-Dallas
@TwoBroadsTalk @MollyJongFast @MuellerSheWrote @FDAMedia @FDACommissioner @RogueFirstLady @CoryBooker @PeteButtigieg @lauriemcginley2 @DevinCow @oneunderscore__ @tedlieu @danpfeiffer @tarastrong @JessicaGlenza @AGKootenay @lauren_etter @CelesteKatzNYC @KatherineEban @eisingerj @dervj @sarahvmeehan @JimZarroli @NickKristof
@TwoBroadsTalk @MollyJongFast @MuellerSheWrote @FDAMedia @FDACommissioner @RogueFirstLady @CoryBooker @PeteButtigieg @lauriemcginley2 @DevinCow @oneunderscore__ @tedlieu @danpfeiffer @tarastrong @JessicaGlenza @AGKootenay @lauren_etter @CelesteKatzNYC @KatherineEban @eisingerj @dervj @sarahvmeehan @JimZarroli @NickKristof @lauriemcginley2 @ANGELICALAVITO @KarenDSouza4 @evolambert @annawerner
@TwoBroadsTalk @MollyJongFast @MuellerSheWrote @FDAMedia @FDACommissioner @RogueFirstLady @CoryBooker @PeteButtigieg @lauriemcginley2 @DevinCow @oneunderscore__ @tedlieu @danpfeiffer @tarastrong @JessicaGlenza @AGKootenay @lauren_etter @CelesteKatzNYC @KatherineEban @eisingerj @dervj @sarahvmeehan @JimZarroli @NickKristof @angelicalavito @KarenDSouza4 @evolambert @annawerner We are adding this thread to our thread to provide more context about what we & the book are talking about.
