Pharma weasel games: Tales of Concerta and Auralgan

The Pediatric Insider

© 2011 Roy Benaroch, MD

I’ve been pretty hard on big pharma in the past—drugs account for a huge part of the cost of health care, and drug companies haven’t always been transparent and fair in the way they’ve priced and marketed new medications. They’re businesses, I understand that, and they exist to make a profit. But the way they game the system to take advantage of gullible docs and patients is sometimes sickening. Two recent stories illustrate their weasel games.

Auralgan is an old medication, an ear drop used to treat the pain that comes with ear infections. For decades it was made with two ingredients, and was sold inexpensively alongside several generic versions. The original product was formulated before current FDA standards for marketing prescriptions, so it was “grandfathered in,” basically allowing it to be sold and marketed “as-is” without proof of safety and effectiveness. It seemed to work well enough, and I suppose no one complained.

A few years ago, the manufacturer of Auralgan “reformulated” the product, adding two more ingredients without changing the name. Naturally, they also reformulated the price—now, cheap Auralgan was priced at over $100. Furthermore, because the ingredients had changed, docs who prescribed “Auralgan” found that pharmacies could no longer substitute inexpensive generics, even though the generics had the ingredients that Auralgan originally contained. In one swoop, the manufacturer dramatically increased the price while eluding generic substitution. Clever, huh?

Maybe too clever. This year, US Marshalls swooped into a warehouse in Kentucky, confiscating 16.5 million dollar’s worth of Auralgan. All new drugs must be FDA approved, and “new Auralgan” had never received FDA approval. It was illegal to sell, and it’s now completely off the market.

A bigger company sells a much bigger drug, Concerta. It’s one of the most popular treatments for ADHD, and one of the biggest selling brand-name medications in the USA. But its patent has expired, ostensibly allowing generic manufacturers to sell their own version of the product (presumably at a lower price.) Johnson and Johnson, maker of Concerta, has fought the expiration of their patents for years in the courts, finally losing an appeal in 2010. But get this: after losing their patent-infringement suit against generic company Watson Pharmaceuticals, J&J turned around and cut a deal with its adversary in court. J&J will now be manufacturing, in their own facilities, an “authorized generic” of Concerta to be sold by Watson. Watson, of course, will pay J&J to make their generic Concerta for them. So J&J will in effect be making the profits off of their own, off-patent Concerta, plus the profits off of the “generic”, which will actually be sold by another company pretending to be their competitor. No wholesale prices have been released, but I’m guessing that this generic Concerta will be priced quite similarly to the brand name. J&J wins. You lose.

Tired of the weasel tricks? Would you like to hear about some real ways to save on prescription drugs? Start here.

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3 Comments on “Pharma weasel games: Tales of Concerta and Auralgan”

  1. Ralph Zamden Says:

    Hello,
    My teenage son has been taking the Ortho-McNeill-Janssen real Concerta for 8 years. (54mg). Yesterday he took his first Mallinckrodt generic version of CONCERTA® (methylphenidate HCl) Extended-Release (ER) Tablets USP (CII). This generic version has an “M” in a box and a “54” next to it. It does not have the OROS shape like the Ortho-Janssen product. My son complained that the effect of the generic did not take effect for almost 2 hours (into his 2nd period class). He typically takes his pill 1hour 20 minutes before 1st period. I will be contacting his physician, explaining the problem and I will ask the physician to indicate to MedCo/ExpressScripts that generic substitution is not allowed due to the differences in the delivery mechanism. I also filled out a report with MedWatch for what it’s worth.

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  2. Dr. Roy Says:

    Ralph, the new “Concerta Generic”, as you said, does not have the OROS delivery system: http://pediatricpartners.blogspot.com/2013/04/generic-concerta-not-working-like-brand.html. I agree, this product should not be substituted for Concerta (or the Watson version of Concerta, which is OROS, and is made by J&J.) Pharmacists should know this.

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  3. TAG Says:

    In our office experience, patients have been getting Mallinckrodt brand generic Concerta and pharmacists have been telling them it is the same as Concerta. Some have bottles filled with both Watson adn Mallinkrodt. Most have called our office complaining that the M. generic is significantly different in timing and effectiveness of treatment. Some patients have had extreme experiences.
    The OROS delivery system is the key to Concerta’s consistant delivery of medication. Some pharmacists said they will not order Watson now, too expensive for them. (yep, no profit) Need to report to Medwatch or your physician with specifics problems regarding this generic from Mallinckrodt.

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