Saturday, July 31, 2010

The Children's Tylenol Statement

This is the statement being appended to all adverse event reports related to the recall of children's products from McNeil's Ft Washington plant, including Children's Tylenol. No other comments here - PB will just take the Wikileak role. We report, you decide.
Additional information received on 11-Jun-2010

On April 30, 2010, McNeil initiated a voluntary recall of multiple liquid products manufactured at the Fort Washington facility that are within product shelf life. Some of these 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.

1. A total of 26 lots were manufactured with Avicel RC591 FMC (supplier) lot DN08819943 as an inactive ingredient in some lots of the following products: Children's Tylenol Suspension 4 oz. Cherry, Infants Tylenol Suspension Drop ½ oz. Grape, Infants Tylenol Dye Free Suspension Drop 1 oz. Cherry, Children's Tylenol + Cold Multi-symptom Suspension 4 oz. Grape, Tylenol Pediatric Cherry Suspension Hospital/Government 4 oz., Children's Tylenol Suspension 4 oz. Grape, Children's Tylenol Suspension 4 oz. Bubblegum, Tylenol Grape Suspension Drop Hospital/Government ½ oz., 15 ml package, Children Tylenol Dye Free Suspension 4 oz. Cherry, Children's Tylenol Suspension ½ Cherry, Children's Tylenol + Cold/Cough Dye Free Suspension 4 oz. Grape and Infant's Tylenol Suspension Drop 1 oz. Grape. Subsequent to release of these products to market, it was discovered the supplier had separated out a portion of the lot for the presence of gram negative organisms. That portion of the vendor lot was not shipped to McNeil nor used in production of finished product. Corrective actions had been previously implemented with the supplier. No additional corrective actions are needed.
2. 3 of 10 lots of Infant's Dye Free Tylenol Drops, Cherry manufactured utilizing a 1000 gallon mix and 1000 gallon hold tank were rejected for failure to meet the potency specification for samples pulled from the end of the batch. The 3 lots were not released to the market. However, this batch size utilizing the 1000 gallon mix and hold tanks will not be manufactured in the Fort Washington facility without re-assessing the batch size development and re-validation of the process.
3. Other lots may contain tiny particles. Investigation to date has revealed potential root causes to be the filling equipment used in production and some raw material. Corrective actions are being developed and will be implemented prior to production resuming.

In all cases, the products were voluntarily recalled as a precautionary measure.

Thursday, July 15, 2010

McNeil From the Ground Up - EXCLUSIVE

Not yet released to the media (I don't think):
Johnson & Johnson announced internally that they are closing their Ft Washington, PA McNeil Consumer division plant until well into 2011, and laying off at least 75% of the operations staff there. This includes manufacturing, packaging, QA, planning and other staff. There are non-operations personnel there who are not affected. This site was where the recalled children's liquid products were produced.

The layoffs are considered permanent, but when they re-open the plant in 2011, they will consider re-hiring laid-off staff. The re-hiring will be on a much smaller scale however, as they introduce much more automation into their processes. They will also likely hire people as contractors, to avoid paying them benefits, according to Pharmablogger's unimpeachable sources.

The plant is being rebuilt from the ground up, literally. The new floor will be poured soon, for example. The effort is to make the plant "pharmaceutical grade" (what was it before?). Meanwhile, the FDA continues its proctology examination of the company, with a J&J Toronto plant in its sites.

Laid off workers will have an option for severance of 2 weeks for every year of service. It was a tough day in Ft Washington today, we hear. Coasting on your reputation for too long will only earn you hubris and disaster.

Tuesday, May 25, 2010

Do you recall.....?

Pharmablogger loves stories of executive follies. Now, there's nothing new about the Johnson & Johnson / McNeil recalls of Tylenol products for various reasons, but pharmablogger has learned that J & J CEO William Weldon (2009 salary $25.6 million) can sit back and bask in the glow of triumph, as he seeks to make McNeil as low-cost a manufacturer as possible. You see, in one drive for economy, McNeil switched bottle manufacturers in Puerto Rico, to a company that used Brazilian pallets that were not heat-treated, but rather chemically treated, resulting in that musty smell that greeted users of Tylenol Arthritis and other products. The smell came from the interaction of the chemically treated pallets with the bottle resin. Yet, J & J came out ahead, right? After all, according to internal sources, the company saved $820,000 by switching bottle suppliers! WOW!

So if you're a J & J stockholder, you might want to let him know how much you appreciate the savings, unless you think the (currently) estimated $1.2 billion in lost sales (source: NOYB) before CAPA costs are figured in, overshadow that $820 large.

Heavy Metal Poisoning

By the way, don't be concerned too much about the metal particles in your kids' liquid Tylenol or Motrin. It's probably always been there, and heck, kids have been getting healthier every year, right?

You see, the liquid filling machines at McNeil have been washed between productions runs with 190 degree water since, well, a looooong time ago. What happens when metal heats up? That's right, it expands! And the liquid fillers have pistons which make the dowels go up and down, where they rub against other metal when expanded. But it took a packaging mechanic to notice the particles in bottles of water that were run after a maintenance service. Irony - that particular maintenance took place because the same bottle manufacturer had sent McNeil bottles that were too thin, so packaging was suspended for a while.

What about other findings from the FDA, that made the Fort Washington McNeil plant sound like a rat hole? Well, when you lay off 2/3 of your maintenance staff, you're going to get things that go unrepaired, like holes in the ceiling. Or when you lay off much of your packaging staff, and a line goes down, all you can do is re-allocate the remaining people to other lines, rather than waste precious time getting materials off the down line, where they will remain exposed to the air and get "grimy" over the course of a few hours (really?)

Then there are those skids of recalled product that were accidentally shipped back out to customers (whoopsie!) because McNeil and J & J systems don't adequately talk to each other.

I'd love to be at this week's hearings, and maybe I will be if schedules permit. Let's hope the House Oversight and Government Reform Committee, and Senator Tom Harkin ask the right questions.

PB to ailing William Weldon: Got your back, buddy! Get well soon!

Tuesday, April 27, 2010

Not a good week for AZ....

AstraZeneca loses patent case against Dr Reddy's, and then has to cough up court costs.

My favorite passage:

I certainly hope that this ruling chills the sort of unreasonable, frivolous, anti-competitive, anti-consumer litigation in which plaintiffs here engaged. This lawsuit was nothing more than an effort to keep a legitimate competitor out of the market on flimsy-to-nonexistent grounds. Plaintiffs did not engage in zealous advocacy here; they engaged in litigation misconduct. They abused the litigation process and needlessly consumed the scarce time of the court.

Monday, April 26, 2010

Profile of a company founded on fraud?

Try to get through this complaint against Cephalon, involving their mainstay product Provigil. One of the better class action complaints I've read.

What's the next step?

Every year I had to complete training as part of the AstraZeneca Corporate Integrity Agreement (CIA) for improper marketing of Zoladex, which cost AZ about $250 million in fines years ago. Now they will enter into another CIA for Seroquel due to additional improper marketing (can you say "sleepoquel?" Google it). Everybody in the company knew that prisoners and nursing home residents were being fed this stuff in sub-therapeutic doses (for psychotic disorders) to keep them sedated. It was obvious from the sales data. So how does management, particularly sales management, get away with simply negotiating a second CIA? Why isn't there any jail time here? $520 million is slightly more than one month's sales of the drug. As a business decision, this was a no-brainer. If the market for off-brand sales is big enough, DO IT! Your stockholders will applaud you. They may even demand it of you.