Terra Sigillata

Let me just say at the outset that I generally pay extra to purchase brand name medications, prescription or over-the-counter (OTC), because of concerns I have about federal oversight of generic drug manufacturers.

However.

On April 30, McNeil Consumer Products issued a voluntary recall of a litany of children’s cold products under the Tylenol, Motrin, Zyrtec and Benadryl brand names.

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States [in Fort Washington, PA] and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

The complete product list can be found at the bottom of the press release (here) from which the above quote was derived.

McNeil noted that “some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.”

However, an ABC News story on the recall provides an FDA report (PDF) indicating that some of the remedies contained as-yet unidentified gram-negative bacteria.

Your humble blogger was contacted for this story and quoted therein but I had not known at the time of the bacterial contamination. All reports suggest that these problems are unlikely to present any risks to infants and children, pending identification of the bacteria, but this cannot be good – especially since this is the third recall by the manufacturer in the last eight months.

ABC News quoted a statement released Tuesday from Johnson & Johnson, the parent company of McNeil Consumer Healthcare:

“The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate,” the Johnson and Johnson statement read.

This recall is also yet another blow to the widely-held belief in the higher-quality of a brand name drug product over generic drugs, at least in the case of over-the-counter products:
“This recall provides compelling evidence that quality assurance is an issue for all drugmakers, and is not specific to generic products, as many have implied,” said Dr. Jerry Avorn, professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital.

What struck me was the report from the Associated Press and the FDA’s own Q&A site that until these products are back on the market, parents use alternative products with the same ingredients on the labels – i.e., generic versions of the McNeil products – rather than trying to calculate how much of an adult-strength product to use in an infant or child.

I wonder how many parents might switch to the generics, see the incredible price savings, and switch permanently to one of these products.

Commenters at several of the news site also note that there has been much ado about quality control issues at drug plants outside the US; that excuse can’t be invoked in this case.

Comments

  1. #1 Pietr
    May 6, 2010

    Let me just say at the outset that I generally pay extra to purchase brand name medications, prescription or over-the-counter (OTC), because of concerns I have about federal oversight of generic drug manufacturers.

    This statement prefacing this article is about as inappropriate as starting a comment about the Obama presidency and stating initially,

    "First, I have never believed people with dark skin are as smart as Norwegians."

    If you have more justification for the first statement than there is for the second, state what your evidence is. What oversight does McNeal undergo that another manufacturer can ignore? If you no longer agree with your prejudice, why not state it frankly, may I suggest that, “I was wrong,” may work.

    It would be appropriate to state how much money you and your research have received from PHARMA and from its biggest advocate, NIH.

  2. #2 Mike
    May 6, 2010

    I’ve been in Quality Control and Quality Assurance in the pharma and related industries for over 20 years; there is no difference between the federal oversight. Any drug manufacturer must adhere to the same federal laws, and the FDA isn’t necessarily “kinder” to manufacturers of generic drugs – why should they be? A drug product is a drug product.

    You should be equally, if not more concerned with big pharmacutical companies; many persons get the impression that the multi-billion dollar companies have their compliance act completely together. After all, they appear to have the most automation, best computer systems, best programs, etc. However, once these huge, driven-by-increasing-stock-price organizations permit the sacrifice of compliance to accomidate production, they start digging themselves into a hole. This is appears to be what happened here. The fact that multiple lots of the same product had the same problem demonstrates that the company didn’t (or didn’t care) to halt production while a suitable invesigation was peformed and corrective actions taken…

  3. #3 skinman
    May 6, 2010

    I’ve got six bottles of recalled McNeil product at home (some almost empty). And I was suprised at the difference in price when I bought the store brand. My wife has always insisted on name brand and I’ve always been ambivalent. Not anymore. After this recall I have no desire to ever have Children’s Tylenol/Motrin/Benadryl in our house again.

  4. #4 Lora
    May 6, 2010

    @ Pietr:
    Review, Meredith PA 2009 Curr Med Res Opin 25(9): 2179-89

    Specific drugs:
    DelTacca et al. 2009 Br J Clin Pharmacology 68(1): 34-42
    Angeli & Trezza 2009 Clin Drug Investig 29(10): 667-676

    The concern from clinicians is that although there may be equivalent concentrations of active ingredient in the final product, the excipient formulation changes in generics can create significant changes in ADME & PK. The original manufacturers do more work on the front end of the formulation process as they are prepping for clinical trials, so it’s assumed that they would have worked out all these type of issues as part of the preclinical testing and the Phase I process. Generics don’t have to do any of that really, they simply have to make sure there’s enough drug in each pill/spoonful–as long as the excipients don’t list “arsenic” as an ingredient, they’re pretty much good to go. Post-commercialization, yes, they both are supposed to be subject to cGMP. I know when drugs I worked on go to commercial, I still get the occasional phone call from my colleagues for troubleshooting help; generic manufacturers, in comparison, can’t phone up the discovery scientist and ask what they did about batch-to-batch lactate variability.

    Anyways. Abel, did you read the 483? Apparently the place was filthy, held together with duct tape, crap lying around everywhere, bags of random stuff leaking powder all over the warehouse, no incoming QC process. They were hiring unskilled workers off the street with no training, had no SOPs, and were using NPCW in formulation, and the outgoing QC was fudging their numbers to make it look good! I will be really surprised if they don’t get a consent decree.

  5. #5 Abel Pharmboy
    May 6, 2010

    Pietr, I’m afraid you are overreacting to my personal preference to use brand-name drugs. If you are a regular reader or took the time to visit my “About” page or sample any posts, you will see that I am equally critical of the FDA, pharmaceutical companies, herbal manufacturers, nutritional supplement dealers, and anyone who misuses science or their place of public trust.

    Lora raises some very good points about the crucial differences between generic and brand-name manufacturers. In fact, the issue of excipients was realized decades ago with the antiepileptic drug, phenytoin, when a change was made that caused the drug to become more bioavailable. So, that is why I generally stick with brand-name drugs when a brand-name has worked for me in the past.

    But yes, Lora, I looked at the 483. The place was indeed held together with duct tape and masking tape. What a mess.

    Mike, I also appreciate your comments and experience. My point about generic manufacturers may not have been clear, however. I don’t think that they are treated kinder by the FDA; I just know that subsequent monitoring of generic mfrs can be less stringent than for brand-name mfrs.

  6. #6 Adam
    May 6, 2010

    Unless regulation in the United States is vastly deficient compared to Canada, I don’t understand what the difference could possibly be. For a generic drug copy to be considered bioequivalent and therefore freely interchangeable with the brand name drug, it has to go extensive serum concentration profile testing to make sure that it is within a given confidence interval (either 90% or 95%, can’t remember off the top of my head) of the patented formulation.

    That said, as far as I know this only applies to prescription drugs. I’ve never heard of OTC meds being certified as bioequivalent to a given brand name. And for that matter, unless you’re talking about a drug with either a special release profile or a narrow therapeutic index, this all seems to be of questionable practical concern. And more than that, this is Tylenol – it’s a rather questionable assumption that McNeil has, for decades, had a perfect serum concentration profile for acetaminophen that no generic manufacturer could ever approach, and an even more questionable assumption that this could translate into sub-par therapeutic outcomes.

  7. Because parenting a sick child isn’t challenging enough. I tossed three bottles, two were about half empty.

    The proponents of homeopathy will be all over this…

  8. #8 Pietr Hitzig
    May 7, 2010

    I appreciate that you are answering my concerns. I am sure that you make sense but I am up too late to fairly critique what you have written. I would say, enjoy the reprieve but I strongly suggest your answer will scare me away.

    Adam, you might enjoy seeing what I have at my URL. I do a lot of neat tricks by administering antipodal monoamine precursors with a particular particle. I can be reached directly at phitz96@gmail.com. It seems that one can stop addictive craving, affective disorders and remit pathologies associated with either Th1 or Th2 bias. Give me a call if you want at phitz96@gmail.com

  9. #9 AB
    May 11, 2010

    @Pietr Hitzig It’s a small world, after all. Pietr, how shocked I was to see you here…we meet in the electrons again. It’s been more than 10 years. Why am I not surprised to find you on a science blog saying what you do???

    I was just about to post: Who uses this crap anyway? It’s toxic and frankly I thought it was used only by the uneducated poor who get sucked into so much corporate swill. I am shocked to see people not only use it but argue which is better – the generic or brand name.

    But who here cares about that? No one, I suspect. I am always amazed at what people buy probably because I make assumptions everyone cares as much as I do about not using this crap, especially for kids. I am always wrong. Advertising is powerful stuff.

    Don’t know if you know who I am, but I see your email and will write.

  10. #10 Advocate Mom
    May 25, 2010

    You are right AB, I have been uneducated as a nurse who works with physicians who recommend this toxic swill. We gave it to our child who had bloody diarrhea for months, anemia, thrombocytosis, enlarged liver, enlarged spleen, anorexia, failure to thrive, pancolitis… She was given a diagnosis of life-long illness -ulcerative colitis. But 2 exacerbations of such illness coinside exactly with her taking these recalled products, twice. Reporting this use to her physician ended up in no mention of such use in dictation/transcription. Personal responsibility. Medicine. The bottom line is money. Safety matters if you could be sued. Safety doesn’t matter so you can be safe. -Perfection of means and confusion of ends seems to characterize our time. -Einstein

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