Johnson & Johnson Does More Damage Control

I had numerous issues with JNJ manufacturing of pediatric prescription drugs while at FDA.

FDA management repeatedly ran interference for JNJ. There appeared to be coordinated harassment of me by JNJ and FDA management including JNJ making complaints against me so things could be put in my evaluations so I could be fired. (That was thwarted by my team leader who said JNJ was making things up. Lilly also tried to do the same thing but my team leader stood up for me then too.)

When JNJ couldn't get manufacturing problems by me, FDA management created an entire new group who was agreeing to manufacturing changes based on JNJ promising to someday do bioequivalence studies.

So what if they didn't do it, or if they did it and they weren't bioequivalent. Well there would have been nothing we could have done at that point.

From CafePharma --I know!-- but this sounds like a credible explanation for things turning that bad:

"McNeil manufacturing leadership was eliminated for all intents and purposes late 2009 as they were absorbed into Consumer, in name only, since no one in Consumer Operations took ownership or paid any attention to McNeil. And, if they did, they had no real gXp experience and governed under their own interpretation of the guidelines."

Or, J&J management made the basic error of assigning responsibility for Tylenol and other OTC drugs not to its Pharma division but to Consumer Health Products, bundling it together with band-aids and mouthwash. That was a bad call because these people did not understand the full implications of being drug manufacturers. And then J&J downsized the people who did.

It must have looked like a good idea from a sales & marketing perspective. And a way to reduce management overhead (a commendable action in itself).

McNeil was taken by the ear and their faces were planted into their own pile of dung, and they did nothing but turn their heads and/or bury them in the sand.

NTBT Ever.

EVER!

Is this all, or at least partially blame-able on the shoulders of McNeil? Who else has their hands in the soup?

Yes, that is a question worth investing time in getting an answer to.

MB

I ran into a woman with an infant last evening who says that she has had to throw out lots of suspect J&J pediatric liquid products lately. Are these folks entitled to a refund?

Yes, refunds are available through http://www.mcneilproductrecall.com/

To me, a pediatrician, this reinforces my recommendation to parents to buy the store brand whenever possible. Good manufacturing is not something that only brand name players can do, and certainly a contract manufacturer has the greatest incentive to do it well. If a contract manufacturer screws up a batch or two of store branded OTC generics how long do you suppose they keep that manufacturing contract?

If there were only three (current) liquid products available for parents to give their children under age 6, I (and the country's children) would be just fine. Children's diphenhydramine, acetaminophen, and ibuprofen are really the only OTC products I ever recommend. My personal practice is to never recommend the infant drops of any medicine - too difficult to accurately measure the more concentrated formulations, and too expensive per dose. The children's formulations of the three products are dosed consistently by weight across the three drugs, making it easier on parents to remember recommended dosing and dose schedule.

All of the other combination products, cough suppressants, decongestants etc are not proven to be safe and/or effective in children - so they are just a means to separate worried parents from their money. Giving a child a "medicine" provides some outlet for the frustrated/concerned parent, but if this increases the risk of problem for a child, or masks an important symptom or condition needing entirely different treatment it is actally counter-productive.

The moral of the story is that parents should seek the guidance of their child's doctor prior to using any over-the-counter medication. Truly, viral illnesses (colds/upper respiratory infections, fevers, gastroenteritis) are universal experiences for children. These are the reason for the vast majority use of OTC medicines. These illnesses are largely self-limited, and require little or no treatment. The shame is that there are ways to more effectively relieve symptoms which are safer and more appropriate than most over-the-counter medicines marketed for use in children. Unfortunately there are not many ads promoting the use of saline nasal irrigation, but there are many for decongestants and cough suppressants.

Perhaps this experience will serve as a wake-up call that the vast majority of OTC (and prescription cough-cold) medication use in children is neither needed nor especially helpful. Though it may be heresy to state it, I don't know why we taught parents to be so afraid of things like fever, colds and ear infections.

Dr. Helm,

I hate to inform you of this fact, but in many cases, the store brand is manufactured by the OTC "name brand" company. In fact, in a prior position, I was aware of several store brand "private label" products that were actually produced by my company (the OTC "name brand") literally from the same stock material as the name brand labeled products. In fact, it was SOP to routinely fill these private label materials on the same line from the same bulk drum with the same lot code as the materials that were produced under our "name brand" on the same filling.

This is an issue that most people outside the industry don't realize, but it can become a significant problem.

Vic, I did know that often the brand and the generic come off the same line. This is also occasionally true for prescription products as well. I often tell this to families - who are typically surprised to learn it.

Since you've had the experience - Did you ever have a recall that affected store branded product? If so, what were the consequences - financial penalties, loss of the contract?

There are still greater incentives (and consequences) for a contract manufacturer to get the manufacturing right. Store brand recalls do happen from time to time - usually with less fanfare, but if a consumer already knew that there is nothing special about Motrin brand children's formulation, they could confiedently go to a Walgreen's and pick up a bottle of ibuprofen liquid. Having recently been to a Walgreen's, I know their product is still on the shelf - many other store brands/generics also continue to be available.

Roast 'em!!

So did we determine if J&J makes any of these other products? I knew it went on but I'm still not clear. Is there a site that shows drug company affiliations? There should be! Who can keep track? :/

http://www.pharmalot.com/2010/05/on-the-couch-weekend-reading-7/#comments

Dr. Helm,

I can honestly say that I have not been involved in product recalls in my 15+ years in the industry. I don't know if my employers have been "lucky" or if they have simply not had the same issues as have plagued many of the pharma companies in the past several years. However, I would suspect that if a company were to have a private label recall attributed to their manufacturing deficiencies, it would likely result in financial loss (e.g., the manufacturer having to cover the costs of the recall and replacement product), possibly further sanctions (damages for reputational loss), and if the recall is serious enough to significantly injure the private label owner, you are likely to both lose the contract as well as several other clients.

JaT, I have no idea who makes products for which private label. As far as I know there is not a list where you can determine this because this data is likely considered proprietary as it would, in effect, constitute a client list and therefore would likely not even be disclosable under a FOIA request to the FDA. More importantly, it is difficult to determine who actually manufactures a product that is a "knock-off" of the branded material and who actually buys the branded material with their own label especially since most of the private labels tell you what product to compare the private label to but then also note that their product "is not manufactured by _________, maker of _________".

Vic, now we know that you haven't worked for J&J!

It seems there should be a way to answer JaT's question with the NDC or some other code on the label. FDA maintains an NDC look-up database here: http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm. I don't know that private label OTC products are included. Certainly the NDCs I find on the store brands sitting around here do not link to anything in their database.

Seems almost like a consumer protection/patient safety question to be able to determine who made the stuff you are taking. Can't imagine why this information would need to be kept secret from the consumer. Who would really care if the Target brand and the Wal-Mart brand came from the same plant (or even the same production line)?

On the other hand, good luck trying to figure out from what processor and which facility your supermarket beef comes.

This comment is late but I hadn't notice this part of the thread. I couldn't find the example I wanted from 2006 which was gigantic but these links will take you to two examples of store-brands being recalled:

http://www.fda.gov/Safety/Recalls/EnforcementReports/2004/ucm120306.htm

THEN SCROLL DOWN to:

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III _______________________________ PRODUCT Aspirin, Enteric Coated Tablets, 81 mg, 120 count bottles, Adult Low Strength Pain Reliever .....

Here is a significantly larger one - 2.8 Million bottles for at least 10 store brands] also scroll down to Class III recalls:

http://www.fda.gov/Safety/Recalls/EnforcementReports/2004/ucm120327.htm

PRODUCT GoodSense brand Children’s Allergy Relief, (Loratadine) Oral Solution, 5mg/5mL, 4 fl. oz. (120 mL) bottles, Fruit Flavored Syrup, Antihistamine, Non-Drowsy, over-the-counter, Manufactured by [REMOVED NAME for this posting] ----- Also sold under the following brand names:.....

Conclusion, it happens all the time, unfortunately. Just read the Enforcement Reports.

Follow-up: This recall involved over 11 Million bottles with over 20 store brands. It happens.

NOTE - The company involved has, to my knowledge - and I have NO "inside knowledge" - taken significant steps to improve processes and address such issues. And, despite the product involved, it is NOT McNeil.

Source: http://www.fda.gov/Safety/Recalls/EnforcementReports/2006/ucm120430.htm

November 29, 2006 06-48 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

PRODUCT Acetaminophen caplets, 500 mg, packaged in bottles of 24, 50, 65, 100, 250 and 500 caplets under the following brand names: ....