Yes, of course there is an �Office� but that's not what he said. He said "FDA criminal division" which does not exist. While pedantic, the distinction is knowing the difference between an "Office" and a "Division" within HHS, which the poster did not.
At the risk perserverating on the topic, I would suggest that QS/GMP warning letters represent the ebb and flow of doing business in regulated industry. At one moment you�re the darling, the next you�re the scourge. Of course, the truth is somewhere in between since FDA general counsel rarely, if ever, signs off on such correspondence.
A false premise invariably leads to an incorrect conclusion. Now I�ll go away.
Look, I can tell that this is an emotional issue for you. But take a moment to consider your comments in view of the recent Utah Medical case http://www.utahmed.com/pdf/FDA%20Trial%20Decision.pdf where FDA sought injunction, re: alleged QS/GMP �violations�, and was scolded by the court for over-reaching its authority. The significance of the 1/26/06 warning letter was stated quite well, in my opinion, by the prior poster �valuator2�.
Also, please note that there exists no �FDA criminal division� http://www.fda.gov/oc/orgcharts/orgchart.html
That's all I have to say on this, so I apologize in advance if I don't respond further. Good luck to all BSX investors.
I have practiced U.S. Food and Drug law for 25 years. Your statments are not only incorrect, they are false and, I would suggest, intentionally misleading.
Talk about naivet� regarding FDA authority. Certainly whenever the agency requests a meeting w/ Co. execs, a serious discussion will ensue. But FDA is not the DOJ, nor is an FDA allegation a proven fact before the courts.
Maybe, but at what cost? At $27 bil, which exceeds BSX own market cap, it may win the battle but lose the war. BSX seems to be betting the farm on this fight.
Point taken, but then you never know what the future holds. People in glass houses, etc., etc... Still, the combined companies would become the worldwide cardiovascular leader.
Please... are you telling us JNJ has not had its own problems with recalls and product quality? Least we not forget that JNJ remains under an 18 month old Warning Letter causing FDA to put on hold the review of any further applications until they fix CYPHER manufacturing. No, this sort of thing is part of doing business in regulated industry. How a company handles it is important to be sure, but that it happens is no indictment of the company. My two cents, regardless if its to be JNJ or BSX, trust but verify�.
The only way would be for JNJ to honor the original agreement with GDT... Frankly, I like the BSX deal better...
According to the piece in Fortune last May, JNJ+BSX can't happen. At least while Pete Nichols still has a voice in the company.
Maybe so, but it's not working. JNJ has more to gain from GDT than the other way around, and GDT knows it.
Acquistions are coming, and I'm betting BSX is in the mix. Discussions on this board on this topic are excellent.
I wouldn't be suprised to see BSX/GDT flirtations. I also agree with those that see MDT or MRK taking a hard look at BSX. Should be interesting Q4.
The same GDT operation that has an active recall manages to gain FDA approval of a Class III device. That says the agency has confidence in the quality systems in place. Rumors of GDT's death are wildly exagerated.