What did they know and when did they know it? As it turns out, Johnson & Johnson's McNeil Consumer Healthcare unit learned of potency problems with Motrin in 2008, but instead of issuing a recall, the healthcare giant hired an outside contractor to buy Motrin from stores to determine whether a recall was needed. But the contractor's employees were instructed not to discuss a possible recall (look at this note by the contractor).
"We were informed that the company was considering what, if any medications needed to be recalled," FDA deputy commish Josh Sharfstein testifed before the House Committee on Oversight and Government Reform, adding that criminal penalties are being considered (see his opening remarks as well here). "...A state board of pharmacy contacted us that a J&J contractor was buying up all of the product (they could get) at stores with instructions to make this look like regular purchases. There was to be no mention" of a recall.
"This 'phantom recall' warrants further investigation by this committee," Edolphus Towns, the committee chair, asked in his opening remarks at today's hearing. "Who at McNeil and Johnson & Johnson knew about this scheme? How high up in the corporate suite was this scheme hatched?" As you know, J&J did not actually recall Motrin and other problem products until July 2009, when FDA inspectors asked about the contractor. The hearing is still under way. UPDATE: At 1 pm EST, J&J's head of its global consumer healthcare biz, Colleen Goggins, insists the FDA was aware of efforts to contractors to canvass and gather products, and that six key exec positions were changed, including OTC quality and OTC manufacturing. By July 15, J&J will have a 'master plan' to clean up its act.
12 Comments
Maybe someone should try to find out what is easier and more profitable for the retailers who stock and sell the product, a phantom recall or a real recall?
Amazing hearing wasn't it. I was really struck by the fact that Congress had a copy of a document telling the contract employee purchasers to say they were simply checking distribution channels if asked and to not mention a recall of Motrin.
The reason I was struck by this is because the JNJ exec said she didn't know what the contract employee purchasers were instructed but that JNJ was having them do it simply to check distribution channels.
Amazing that they were purchasing all Motrin on store shelves from batches with problems just to check distribution channels.
Salmon
I wonder if contract employee purchasers were the reason for no regular (adult) Tylenol being on the shelf at one store over Easter weekend. There was no sign about a recall or a backorder.
Likewise, the off-putting present info dosen't address other McNeil products nor all of it's hired contractors as applicable.
FDA, you are failing miserably. Why?
MB
Does anyone know if there is a place where I can check the lot number on my full bottle to see if it's okay? If not I'm gonna scrap it.
JaT --
Click here; check your product name -- follow the instructions.
That's the official McNeil Product Recall Center.
नमस्ते
One more, JaT --
The earlier (January 2010) recall mechanics and lists are here (inculding OTC Adult Tylenol).
नमस्ते
The "phantom recall" is certainly worrying.
But Goggin's written testimony also contains the following remarkable sentences, which should not be lost in the noise:
"Indeed, over the past several years, McNeil’s quality expenditures and investments relating to the Fort Washington plant have increased. (...) We also want the public to understand that McNeil had a very detailed testing and quality assurance process even before the recent recall. (...) McNeil also has detailed processes for assessing and investigating consumer complaints and reports of possible adverse events from its products."
Reassuring if true -- but very much at odds with the FDA's observations.
JaT,
There should be a phone number on the label which may guide you.
MB
I think people are focusing too much on specific lots. The testimony I heard today was of just a general lack of any sort of quality in their manufacturing processes at all. The sort of thing that goes well beyond any single drug or lot and goes to a corporate mentality of we simply don't care.
First example. The superpotent pediatric Tylenol (I believe infant drops). If it is the infant drops overdosage in some infants given for a fever over more than a day or so could result in liver failure and death. The way this happened is JNJ wanted to increase the batch size so they simply did it without seeing whether or not it worked first and then they shipped out the product without even testing it. Think of it this way if you're mixing a cake it's pretty easy to mix everything well if you're only making a small amount. But if you increase the recipe it makes it much harder to mix the ingredients evenly, so instead of mixing for 5 minutes by doubling the recipe you now have to mix for 20 minutes to make sure everything is well mixed. If not you get certain areas where there is an excess of sugar and other areas where there is a lack of sugar.
Changing batch sizes and scaling up is done all the time for example when a drug is first coming onto the market and you're going from small batches for use in a few hundred or a 1000 people to huge batches for a 100,000 people. So when you do it you first do 3 pilot batches in the bigger equipment at the new size (minimum 10% of the new size). Then you test it to make sure it worked every time. Then even when you make batches for market you hold them in storage and you test every single one before you release them for market. This is standard procedure and standard good manufacturing practice. JNJ didn't do either one they didn't do pilot batches and check their new process and they didn't test the first 7 or 8 batches they released onto the market. It was only when they finally tested some that they found they had a problem. Now they claim they went back and tested some bottles from the first 7 or 8 batches that they had kept (this may be done if they're going to check the stability of batches from the new process or may be done as a just in case. In any event that they would do things in the manner described is simply appalling.
Second example. They had a quality control standard of using no ingredients that had gram negative bacterial contamination. (In immunocompromised individuals gram negative infections can kill you. Remember the E. Coli scares with spinach and Jack in the Box, and the hamburger recalls, and I think with peanut butter. Some of these killed people especially children and elderly or caused kidney failure.) Instead JNJ knew they had contaminated ingredients and decided to just go ahead and use it anyway.
Third Example. They simply didn't have procedures on how they were going to test if things were made properly. If you don't have any procedures then you can't do the test.
These are not little things. They basically show a company that's saying we're just going to make drugs and we don't care how they turn out so long as we can simply ship them out and someone will buy them.
These manufacturing problems also go for other JNJ subsidiaries. For example
Sterilization Devices by Ethicon http://online.wsj.com/article/SB10001424052748704026204575266782834194838.html
Dupuy Hip Replacements http://www.drugrecalllawyerblog.com/drug_companies/johnson_johnson/
Duragesic (Fentanyl) Patches made by Alza a JNJ sub (600 times as potent as morphine, 60 times as potent as heroin) leaking patches can cause OD and death http://www.newsinferno.com/archives/2565
Salmon
Fascinating. But I'm getting the feeling that Ms. Goggins is just the scapegoat here. They'll give her a package once the dust clears.
It's really not surprising that the committee had the documents. J&J loves its memos. I bet there is a paper trail long enough to pave a highway from New Brunswick to Rockville. Employees have to be sprinting to the nearest attorney's office to try and get in the whistleblower suits that are surely moving forward.
Thanks for all of the information. I did toss it.