FDA is not god who can light you up and burn in hell, why you're afraid of it?

Remember the old saying: Everybody can be bought, it's just matter of price.

"Consider our president can leak out so much about national security without consequences (except political gains), you think what we discuss here worth the time of Siemens in house lawyers to investigate? Give me a break."

Save your political comments/unproven allegations for one of those right wing Republican sites. Or were you talking about Scooter Libby, Dick Cheney, et al. who outed one of our CIA agents, Ms. Plame? Your comment is totally irrelevant and inappropriate for this site.

Abbott was unable to 'buy' the FDA. What makes you think Siemens can? This is serious, but not nearly as disastrous as some here are making it out to be. It doesn't appear that you have much direct experience dealing with the FDA.

I don't think Siemens should give a shit about FDA, which can be easily bought. Siemens can bribe their way out every time just like their successful stores in Russia and China.

To the "shock and awe" post below, what is IPO address? You meant Facebook IPO? LOL.

Consider our president can leak out so much about national security without consequences (except political gains), you think what we discuss here worth the time of Siemens in house lawyers to investigate? Give me a break.

What a bunch of nervous Nellies there are here. It's true that it is never a good thing to get a letter like this from the FDA, but it also not the end of the world. The prediction of a re-validation of many methods and them being off the market for 18-24 months is both wishful thinking and fear-mongering on the part of the competition. The comments about DPC to the rescue is just more wishful thinking and fantasy on the part of the head-in-the-clouds gang in LA. The communications noted to date between Siemens and the FDA are part of the normal 'give and take' between protagonists. It is very common for companies to wait until the last minute to respond to an FDA letter and the FDA knows that. There was nothing in their response that used words like 'unacceptable' or 'gross violation in the response'. So far, it does not appear, that Siemens has told the FDA to 'f*** off' or 'go to hell' which was the big mistake that Abbott made and caused the FDA to completely clamp down on Abbott. It's somewhat of a game, folks. The key for Siemens is to maintain a posture of cooperation and doing what they can to clear things up with the FDA. Acknowledge the possibility (or probability) that the deficiencies are real and that you will do everything within your power to remedy them and to do so as soon as reasonably possible.

But before customers go rushing away from Siemens and have to worry about things like finding an acceptable replacement and do all the qualification work for a new system (generally a minimum of a months work), they should wait and see what is really going on. Listening to the competition making claims that this will affect 8-10 assays when the letter comments only about a single, esoteric method, is a sign of panic, not rationality. Customers should not be acting out of fear induced by competitors, but on real facts and data. Siemens will tell them it's not a big deal; competitors will say it's the end of the world (or at least Siemens' world). I recommendation for these customers is to get more information before making an expensive decision that may not be necessary.

Sic semper timore mongers !

- or -

So jemals Angstmacher !

Siemens has a policy on what you say regarding confidential information posted. They have the ability to get IPO addresses if they feel warranted to do so. Think before you speak.

Based upon response, sounds like Siemens is not taking this seriously. If an assay is not properly documented, it is not allowed to be on the market. Previous poster stated Centaur assays will be pulled off market for 18-24 months, as Siemens rushes to get through all the re-validations.... I suspect much longer. I'm guessing Siemens will be pushing out the door DPC units everywhere to compensate for all the Centaur assays being taken off the market. Guess they'll have to turn the lights back on in their california office. DPC to the rescue?

Quote from FDA letter to David Hickey, Siemens DX CEO:
Your firm's response to the Form FDA 483 (FDA 483) was received by New York District via email in an unsigned document after the close of business on the fifteenth business day after the FDA 483 was issued. The email did not provide attachments related to your response. However, the email indicated a signed response as well as attachments were available for the FDA by logging onto a Siemens File Exchange. The District did not and does not plan to logon to your firm's File Exchange to obtain responses or other information. In addition, the email indicated a hardcopy response was being sent to the District Office. The District received your hard copy response on January 23, 2012.
END QUOTE

OK, I don't work in the DX field, I work in medical devices. I also don't work in quality and regulatory. However, when I read the above paragraph, my jaw shattered on the ground and my blood ran cold. All I know, is that "where I come from", you mention the three letters F-D-A and we have the attention of ANYONE within earshot. We live in holy terror of these three letters, and we don't want them anywhere NEAR our business. Did the persons responsible for the response to the FDA get fired? Did David Hickey get raked over the coals? How could he have allowed such a response to get out of the door? Was he not aware of it? Are those responsible for this letter malicious towards Siemens DX and trying to get the FDA to stick their nose in its business? And are things so bad at DX that this tactic was actually the morally correct thing to do? It's like waving a red cape in front of a charging bull. I simply can't believe anyone in Quality and Regulatory could be that incompetent to pull such a stunt - it was either done for malicious purposes or for a morally higher purpose...

Either way, Siemens DX has a TON of stress, work and damage control in its future. Try to enjoy what you can of the summer!

What do you want MR to say? We're in big trouble with the FDA, we have a culture of opaqueness, we're losing customers left and right and I have no clue for how to turn this around. The "truth" at this point won't allow him to keep his job - but it would have in the first year he was at DX. He did try to reset DX with the "goodwill" lowering of DX's value - but it wasn't near enough, and sadly, for MR and Siemens, this WAS a big, risky step.

All he has at this point is Kool-aid to offer. Your choice is to either drink it or run for the hills...

Given outcome of Jonestown, I know what I'd pick!

As someone now on the outside, this is very entertaining.
Do you wait for your package, or do you go with one of the companies that liked your resume?
I say run as fast as you can away from this horrid organization.

No quick fix for this.
In meetings at Tarrytown the possibility of certain kits being pulled from Centaur menu for short term might very well take place.
This will be a major problem. Cause and Effect. We'll lose more customers. MR see's this as an opportunity? We see this as a disastor in the making.
The ripple effect throughout DX is a competitors dream come true.
How bad will it get? We'll know in a few weeks. Always hard reading the FDA.
Tranparency has never been one of Siemens virtues.
What we do know...the next few quarters will be very bad.
I assume things are getting ugly at Walpole as well.
Emergency Town Halls are being scheduled.

"Well as a Siemens' employee who is supposed to be driving the business, and revenue, why would you be sharing verbatim to the public what MR or anyone else in the company is saying? Isn't pulling the company down even further the job of your competitors? You shouldn't be working there if that's your attitude."
END QUOTE

I seriously doubt this company can go down any further.
My attitude is also the attitude of the majority of DX workers here. Tarrytown is a hot frying pan. Everyone walking around acting like a noose is around their necks.
We need better management and a new CEO. FDA on verge of creaming us. Competitors aren't bring us down. We do that quite well ourselves...and we lose customers each and every quarter.
Unless DX gets a drastic overhaul you should expect selling off to begin right after the "Agenda 2013" flops out big time.
You don't like the truth then don't come here.

It can be read to imply a systemic problem, you're right. I considered the possibility that several assays could be affected and that their quality system could need some overhaul. I was questioning whether they would have to actually re-validate methods or simply find all the pieces (files) and get them together and implement a system consistent with FDA quality systems (and ISO as well). As long as Siemens doesn't get arrogant and maintains a co-operative attitude, it will take resources, but the punitive actions may be minimal. Alot depends on the specific FDA people they will have to deal with and the general mood of the FDA which seems to swing between over-zealousness and almost anything goes. I'm sure that the lights are burning late in Tarrytown and Walpole tonight. If necessary, Siemens will suspend most non-essential activities to get people working on this and getting it all straightened out. If not, they will suffer a fate worse than Abbott did, because, at least, Abbott had a basic culture that knew how to eventually recover.

[Have you actually read the letter? It's about one particular method and "**whether it was reviewed properly during development, whether proposed changes in manufacturing are properly assessed and formally reviewed**"...]
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This wording implies that FDA feels it's a systemic widespread problem. The nightmare has only begun, and other assays will most certainly be sucked into the whirlpool.

Just ask Alere. They not only have an ongoing recall of >800,000 tests, but now have received a subpoena regarding their QC practices from HHS.

"Internally, Siemens is expecting >10 assays to be pulled off the Centaur's menu, re-validated, then re-submitted. Estimate 18-24 months, if all goes well."

Have you actually read the letter? It's about one particular method and whether it was reviewed properly during development, whether proposed changes in manufacturing are properly assessed and formally reviewed, and whether the proper submission was made to the FDA. Worst case is that they may review their entire process and have to go back and assemble certain data for review, but not have to actually do more validation work. But I see nothing in the letter than suggests anything more than a single method at issue.

Internally, Siemens is expecting >10 assays to be pulled off the Centaur's menu, re-validated, then re-submitted. Estimate 18-24 months, if all goes well.
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Not true. Where the heck do you get your info? That is sooo off base.

Well as a Siemens' employee who is supposed to be driving the business, and revenue, why would you be sharing verbatim to the public what MR or anyone else in the company is saying? Isn't pulling the company down even further the job of your competitors? You shouldn't be working there if that's your attitude.

MR's spin on this is so ridiculous I find it truly amazing he's still around.

"From an organizational standpoint, I clearly see this as an opportunity to further accelerate the transformation process that we started last summer within our Quality Management organization and quickly implement needed changes throughout our R&D and Manufacturing processes to better align with the FDA’s current expectations. I know that I can count on you to make quality an integral part of everything we do, so please work directly with your manager to better understand what you can do to make a difference."
MR (Yesterdays announcement)

Well, the rest of us "clearly" see this as an opportunity to get a new CEO, new Senior Management, sell off redundant platforms and finally shutdown redundant sites.
What a silly joke this has turned into.

"You can argue all you want about whether this is the right thing to do, the most open and honest. "

Wrong, there is no argument. This is not right, open or honest. Siemens spouts off about transparency, but it is a very selective brand of transparency.
By not even telling the reps, they are putting them in a very bad position in front of customers. This makes it hard to follow the playbook. Maybe they'll have to call on some of the customers that won't be buying in the next six months. Went into two current siemens customers yesterday. They have not seen a chemrep in 3-4 YEARS.

Internally, Siemens is expecting >10 assays to be pulled off the Centaur's menu, re-validated, then re-submitted. Estimate 18-24 months, if all goes well.

'I don't really think having to sell your self would qualify as "found ways to overcome".'

Yep. Win some, lose some. Assuming that there is a direct relationship between being sold to Danaher and that particular FDA notice. Also, in Beckman's case, I believe the issue had to do with their ability to manufacture the product consistently and meeting claims. The Siemens letter seems to be more related to record keeping, reviews, registration, rather than a technical problem or a product that does not meet its claims. In the worst case, Siemens may have to suspend production, collect additional data, make additional submissions to the FDA etc, but it looks like a situation from which recovery is possible.

Funny how these things can turn out..

Published on April 29, 2010

Headline - "Beckman Coulter's first-quarter 2010 revenues up 27.4%"

goes on to say on final line of 1st Q 2010 sec filing:

"We are determined to resolve our product compliance and quality matters as quickly as possible and are committed to delivering on our long-term goals of recurring revenue growth of 7 to 9 percent and net earnings growth of 9 to 12 percent," concluded Garrett."

I don't really think having to sell your self would qualify as "found ways to overcome".

Why on earth would you expect Siemens to show the notice to its reps? The notice is a week old. I'm sure that there have been many people looking over the letter, assessing what can be done quickly and without any cost, considering the potential impact of the various parts, etc. And the realities are that in a company the size of Siemens, these things take time and are known internally only on a need-to-know basis. If reps feel a need to know, they can look up the letter themselves. It's far more likely that reps would be told that the letter exists and that the only thing they should say, when asked by customers, is: Siemens is reviewing the letter and preparing an appropriate response to the FDA. If questioned about the impact on product quality, they should say: At the present time we are unaware of any negative impact and are continuing to review data to ensure proper product performance. You can argue all you want about whether this is the right thing to do, the most open and honest. I don't think it is myself, I'm just trying to describe what most companies do in situations like this. If they believe the issue to be minor and easy to resolve, they may say nothing at all. Siemens claims to be open and honest like all companies do. It's almost a competition among them all to talk about who is the most open and honest. And when push comes to shove, the companies move into protect mode first. It's almost instinctual. I merely report them.

If competitors want to use this to their advantage, that's a reality too. I'm sure that they are assessing the notice to determine whether they will just see a short term talking point, or a long term affect due to a product taken off the market. This is a chess game in a sense. Beckman had FDA problems; Abbott had big time FDA problems. They are both still in business and have found ways to overcome whatever setbacks they suffered. So will Siemens. Just don't expect it to come out as a shining example of high standards and morals.

Just to show you how transparent siemens is, the reps have not seen this.
Do you think the customers have?

Is this it? It's regarding the intact PTH assay:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm30616...