FDA Finds Problems at Yet Another J&J Plant

We learned over the weekend that the FDA inspected ANOTHER J&J manufacturing facility and issued it an unacceptable (Form 483). This is just another sign of systemic manufacturing problems across all of J&J’s facilities worldwide. And it should be another wake-up call to consumers on the safety of all of J&J’s products.

Meanwhile, last Thursday, J&J issued their report to the FDA on how it will plan to fix its manufacturing mess. The company had promised transparency, so I was suspecting it to post its entire plan online (like other reputable pharmaceutical companies in the past). One thing is clear – transparency and being a reputable pharmaceutical company aren’t on J&J’s mind. Instead, J&J posted a brief statement on its blog (but only after I contacted J&J’s Marc Monseau and questioned the lack of information). As you might imagine, the statement doesn’t say anything and doesn’t address how the company plans to fix the mess.

The most significant step J&J will be taking – mass layoffs. This isn’t designed to fix manufacturing problems, rather, cut costs to preserve bonuses for J&J’s management. The company will kick over 300 employees to curb in September, giving them severance packages. The company then intends to re-hire at least some of these folks in 2011 (if the FDA ever lets them resume manufacturing). In other words, J&J is transferring financial responsibility for the employees from the company to the Commonwealth of Pennsylvania for the next year. The company then anticipates hiring some of the employees back in 2011. I have to ask the question – is that the behavior of an ethical company? How does this square with the Credo (which reads: “We are responsible to our employees, the men and women who work with us throughout the world…They must have a sense of security in their jobs.”)


More background on the J&J manufacturing mess:

• J&J Misses Deadline for FDA Plant Fix Plan
• Patients Sue J&J Over Fraud
• J&J Announces Yet Another Recall
• J&J’s MIA CEO Gets Another Congressional Summons
• J&J Expands Recall; Employees Devastated
• J&J to Congress – F’ Off
• Time to Fire Weldon?
• The Case of the Phantom Recall
• J&J Gets Congressional Hearing
• J&J CEO Refuses to Testify Before Congress
• J&J’s Drug Recall Checklist
• When the Creed is Greed
• J&J’s OTC Products Recalled (Again)
  

Why the J&J Coverage?

Someone recently e-mailed me why I’m focused so much on J&J. The answer is simple – because I believe this to be THE most significant story in the pharmaceutical industry. Period.

As an industry, we have faced numerous public perception problems. J&J’s just fueling that. The one thing you could always count on was the safety of Tylenol – take two and call me in the morning.

But what happens when your Tylenol is laced with a toxic chemical that has an unknown impact on public health and the company has worked hard to cover it up?

That’s the situation we find ourselves in. J&J’s behavior hurts the entire industry.

J&J Misses Deadline for FDA Plant Fix Plant

Back on May 25th, Johnson & Johnson (J&J) announced that it would present a comprehensive plan to the FDA on July 15th on how it would address its massive manufacturing woes. Today is July 15th and no plan from J&J.

However, J&J assures us that the plan is coming tomorrow – only one day late. I can’t say I’m surprised by this. Frankly, I’m not holding my breath we’ll actually see this report from J&J.

Patients Sue J&J Over Fraud

Johnson & Johnson was sued last week by a group of consumers for fraud. Patients are fuming mad that J&J’s solution to the Tylenol recall is to offer coupons to consumers for more Tylenol - which isn’t actually available since the company was forced to shut down its principle manufacturing facility. J&J claims that consumers can also obtain a refund. HOWEVER, consumers have complained that when they have requested a refund, J&J has issued them with the worthless coupon instead. How irritating is that?

The usually eloquent Jim Edwards has a scathing review of the Unsolved Mysteries at J&J over at BNET. Among them, Jim Edwards wants to know why McNeil’s head Peter Luther still has his job. To that, I’d ask the question, why does William Weldon still have a job? At the rate this shaping up, I’m betting the J&J board will sack Bill Weldon, Colleen Goggins and Peter Luther before this is all done. However, they need to get themselves a little distant from the poisonings before they can clean house.

This should be an interesting week for J&J. If you recall, back on May 25th, J&J committed to the FDA that it would present the Agency with a full review of exactly how it screwed up and exactly what it would do to fix it by July 15th. This review was supposed to be conducted by an outside consultant and without any internal bias (although it is unclear if it is the same outside consultant who conducted the now famous “phantom recall.”). J&J also committed to being transparent with consumers. I think chances are good that J&J will make the July 15th deadline. However, based on its recent behavior, there’s not a chance in hell that J&J will be transparent with consumers.

I’ll be eagerly watching this week.

J&J Announces Yet Another Recall

Another day, another J&J product recall. This recall covers both pediatric and adult products in the United States and about a dozen other countries on two continents. What are we up to with J&J product recalls? I think this is recall #7 or 8 major one in the last two years, at least the fourth one this year, and the second one in three weeks.

The reason for this recall? J&J says this is a “precaution” because these additional lots came in contact with the same materials that contaminated all the other J&J products. In other words, these lots should have been recalled before, but weren’t (for some reason). That seems to be a recurring theme with Johnson & Johnson.

Oh, By the Way, if you’re looking for any officially communication from J&J, forget it. J&J is pretending this isn’t happening. There’s been no word over at their official blog JNJBTW on the last several rounds of product recalls. I want to give J&J credit for actually being honest about the problem instead of hiring consultants to get the products off the shelves during the dark of night (like they have done in the past). But doing the right thing should be a minimum expectation, not the exception to the rule that it seems to be at J&J. And if you’re looking for the company to sound concerned about the safety of its products? Forget it.

I’ve said it once and I’ll say it again. We have a company that has systemically contaminated products at multiple sites in multiple countries, has ignored FDA warning letters going back to 2003 and doesn’t seem at all concerned it is poisoning people (including young children). What’s wrong with this picture?

Given the widespread nature of the manufacturing problems at J&J, we cannot assume that any J&J products are safe. These manufacturing problems are systemic across J&J and not isolated to some random manufacturing facility. For me, I question the safety of all J&J’s products. They make a lot of products, from pharmaceutical products (like Risperdal, Procrit, Levaquin, Concerta, Velcade, Aciphex, Prezista, Duragesic, etc.) to health and beauty products (like Aveeno, Listerine, etc.).

It is up to J&J to prove to us that it is an ethical company. It is up to J&J to prove that its other products are safe. The burden of proof is on J&J. We can no longer accept it on faith.

More background on the J&J manufacturing mess:

• J&J’s MIA CEO Gets Another Congressional Summons
• J&J Expands Recall; Employees Devastated
• J&J to Congress – F’ Off
• Time to Fire Weldon?
• The Case of the Phantom Recall
• J&J Gets Congressional Hearing
• J&J CEO Refuses to Testify Before Congress
• J&J’s Drug Recall Checklist
• When the Creed is Greed
• J&J’s OTC Products Recalled (Again)