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End of the Story?
Yesterday, Mylan released a statement saying that the FDA had found its Morgantown plant "in full compliance." Immediately, its share price went up about 5%. A brief sumary can be found here:
http://www.marketwatch.com/story/mylan-fda-clears-w-va-plant-2009-08-13
I have found no report to this effect from FDA itself. Such regulatory actions are not always easy to access, but it may be worth keeping in mind that the last time the company said the investigation was complete the FDA directly contradicted it.
In the meantime, being "in full compliance" now does not answer the question of the compliance status some months ago, and during the two years production warnings were allegedly overridden. Nor does it answer whether, and how much, defective meds may have gotten into circulation.
Since this story potentially impacts so many people, we will continue to follow it.
Friday, August 14, 2009
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What a cool guy that Justice is.
ReplyDeleteThis appears to clear Mylan since an FDA spokesperson is quoted. As I understand the article, the suggestion is that Mylan workers did override computer warnings, but that the problems were caught via other software.
ReplyDeleteThanks, Halfababy.
http://www.bizjournals.com/pittsburgh/stories/2009/08/10/daily37.html
Halfababy, you got it together, dude!
ReplyDeleteThanks, Mon!
ReplyDeleteIs it any less wrong because a computer caught the crime? Why did the fox investigate the crime scene?
ReplyDelete“Mylan said the internal report itself was evidence that its quality systems were working--evidence that it fully investigated any problems that arose. Well, the FDA agreed, saying that Mylan's internal investigation was adequate.” http://www.fiercepharma.com/story/fda-clears-mylan-plant-after-probe/2009-08-14
Case closed. Stock up.
This is my kind of CEO:
ReplyDelete"Coury wrapped up by saying, "I would like to thank all of our employees for their continued hard work and execution..."