Disgraceful embarrassment of an organization

The warning letter was first delivered late 2010. In over two years, the individuals responsible for closing out this letter have been unable to rectify the situation and now employees and patients will suffer. The entire organization was caught with its pants down.

If the goal is to be a first class organization, then Impax has failed. This doesn't happen to first class companies. The CEO should be embarrassed at the reasoning behind this delay and the complete lack of response by the company to its employees, customers and shareholders.

Now it's looks like a 2014 Rytary launch IF the company is able to resolve this by then. This holds up the future of the generic and branded houses.

Great job!

 

Heads should roll for this, but they won't. The scary thing is that when Rytary is eventually launched, it will be under the same incompetent management.

 

I don't place all of the blame with Impax for this. Rytary is not being produced at this facility, and they did not even include it in their paperwork that they filed with the FDA. There's really no legit reason that the FDA has to tie the Hayward facility to Rytary's approval. Personally, it looks like yet another overreach by a government organization, and nothing more. Granted, Impax shouldn't have sat on their behinds for this long to get their facility up to par and re-inspected, but I can see why they didn't think that Rytary's approval would be contingent upon it.

The company stock (and thus, the company) lost approximately 1/4 of it's value yesterday due to this decision. I find it unfortunate that something as petty and trivial as this would be why the FDA chose not to approve Rytary. Hopefully, their inspection at Hayward this week will be allowed to count towards this, and an approval will come sooner rather than later. Anyone know if there is a precedent for this at the FDA, or is the company put back to square one and need to re-submit everything all over again?

 

"...as petty and trivial as this..." What do you think separates US pharma manufacturing from generics mixed in bathtubs in Indonesia? Safety isn't it? This is an issue that was identified in 2010, not yesterday, that hasn't been addressed. The FDA has every right to use what ever leverage they can for compliance, it's no different than assessing a fine except in this case their decision is a penalty in new revenue. Bitch at the FDA all you want, I'd rather ask why this issue wasn't resolved months ago.

 

The saddest part of the whole thing is the patients who will now have to wait for an improved treatment that Rytary would have given them. I hope the incompetent senior managers/directors think about this on a daily basis, and not about their fat salaries and stock options.

 

similar to mngt decision to allow pts on drug during clinical trials to get free drug after phase III results then doing a 180 and saying no pts on drug will have to wait until approval and purchase have already alienated my biggest movement disorders Neurologist cant wait to see how it is priced for medicare part D

 

I'll bet Michael J. Fox still gets his.

 

If the CEO and other C-level management had ANY class they would resign as should the President of Rutgers University !

 

Wow. I just read this. This is a direct quote from my manager! My manager is on cafe pharma!! Most fantastic discovery!