FDA - READ THIS : QUALITY ISSUES ARE BAD IN NOVARTIS

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Anonymous

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Open message to the FDA

Novartis has MAJOR Quality violations
They are mopping them up - well, trying to mop them before they go in knees to you next month to apologize, and HOPE that you (Ms. FDA) don't slap them with a freeze in all approvals and reviews until they fix them (think Gilenya - FTY !!! ....)

Novartis Clinical Research people have done clinical studies WITHOUT notifying you.
They have "classified" Protocol Ammendments as "administrative" - when in reality they were not....and thus bypassing FDA and IRB notification.
They even had patients dose incorrectly (double the dose) - because the "IVRS" misinterpret the protocol instructions....
15% of all investigators were not submitted to the FDA, nor the "bad investigator" data-bank check....
And that's just the tip of the iceberg....there is lots more....

Why all this happenned ?

Because for the past 3 years, Mr Jimenez and Dr Mundel have been talking about "SPEED" at no cost.... "Quality" was forgotten. Their only concern was the Diovan cliff and the loss of money from it....they need new products approve at all costs (including patients' lives)

FDA.....DO SOMETHING !!!
Stop this sloppy company before they harm a patient or worse, kill someone !!!
 






If you know this to be true, and you sound pretty sure of yourself, you'd better get to the FDA in some other way than Cafe Pharma. I doubt Ms. FDA checks this site.
 






I agree with the above poster. If you know this to be true, you need to let the FDA know. Are you afraid of retaliation? If so, I would call a lawyer and have them on retainer so Novartis can't retaliate without consequences.

If this is true, it's a very big deal and perhaps lives at risk. Additionally this is the type of sloppy work and mis- truths that have given big pharma a bad reputaion and a big part of why the industry is in the position it is!

Please do something about this.
 






This could have huge whistleblower potential for you. You have to do the right thing, particularly if you feel that lives are at stake. The implications for Novartis, its employees and its patients are enormous. And this is an issue that doesn't need to be reported internally.
It will only be a cover up.
 






You can go to the FDA website (fda.gov) and file this information anonymously. Due to the severity of your allegations (protocol violations are very serious), you should contact the FDA directly. Good luck.
 






These are very serious allegations. If you have the proof to back up your statement, you need to inform the FDA. If you do not inform the FDA, you are just as guilty.
 






Thanks for the tip op.
I have sent your comments to the right people for you.

If these allagations are true, things are about to get very interesting.
VERY IMPORTANT: If you or anybody else has similiar info, post it, and I will forward to my contacts at the FDA/OIG.
 






Anonymous said:
Thanks for the tip op.
I have sent your comments to the right people for you.

If these allagations are true, things are about to get very interesting.
VERY IMPORTANT: If you or anybody else has similiar info, post it, and I will forward to my contacts at the FDA/OIG.
Click to expand...

Kudos to you if, in fact, this is true. The OP needs to go ahead and make contact though, even if anonymously at FDA.gov. Never know if someone internally might have made this post to assure the OP, and then it goes nowhere. You never know who to trust here. Won't hurt matters if it's reported twice. No offense.
 






You guys are correct.

I copied all the entries here and forward it to the FDA thru www.fda.gov (there is a page that allows reporting of criminal activity)

If anyone nows something else....they should post it and send it to the FDA

Patients lives are at stake....and this company as changed for the worse....and the change happenned 3 years ago, when they started to get rid of ethical and experienced people like Dr James Shannon.
 












All this is correct...

Basel is running scare....everyone is completing all their SOPs readings and sign-off....which have not been done for years !!!!

Everyday there is an email about this topic....

They are under big pressure to get all done, before going to the FDA.

Does anyone has anymore info on the subject ?
 












Anonymous said:
All this is correct...

Basel is running scare....everyone is completing all their SOPs readings and sign-off....which have not been done for years !!!!

Everyday there is an email about this topic....

They are under big pressure to get all done, before going to the FDA.

Does anyone has anymore info on the subject ?
Click to expand...

Wik: Def. of SOP:
"STANDARD OPERATING PROCEDURE" - Main Objectives
a. to systematically record all current business policies, processes and procedures currently followed
b. to clearly indicate the flow of actions performed from beginning to end of the process chain
c. to inculcate a culture of "CONTROL CONSCIOUSNESS" among process owners and operatives
d. to observe shortcomings in these policies, processes and procedures and make suitable recommendations for improvements in the policies, process effectiveness, process efficiency, internal controls and compliance, as applicable, and
e. to serve as a basis for disseminating knowledge on the above among employees dealing with the relevant business functions, to enable adequate training to be imparted to concerned personal with a view to making the business operations person-independent.
f. to act as a reference guide for internal audit, which assesses the extent to which the SOP is complied with.
 






The Original Poster is correct
We FUCKED UP BAD !

This is from one of the slides that Trevor Mundel presented:

Meet Authorities

We have no choice but to meet with the Regulatory Authorities
To convince them that we:
- Want to fix the issue
- We are capable of fixing the issue

We have to offer:
- Third Party review
- Resources
- Organization changes and accountability
- Governance

And this one from John Orloff:

Identified Issues (draft list to be updated during workshop)

Accountability
- Lack of cross-functional (DEV / NIBR / Marketing) accountability and ownership
- SOPs are siloed within subfunctions for same process
- Diffusion of accountability
Cultural mindset
- Speed valued above quality
- Quality compromised for sake of speed
- Compliance viewed as barrier to functional success
- Functions charged with enforcing or tracking compliance viewed as “bad guy” and not strategic
Rewards and incentives
- For strategic work (milestones and business success)
- Not for compliance or operational activities
Resources / organizational
- Rate-limiting in some instances: choose speed over quality
- No centralized training / on-boarding for clinical roles
- Bar raised for external regulatory requirements; we have not adapted our capabilities or resources accordingly


BUT>>>WHO IS GOING TO TELL THE FDA ???
AND WILL THOSE OBAMAITES BUREOCRATS DO SOMETHING ABOUT IT ???

Doubt it....it will take one or two patients to die, and maybe someone will do something....as always.
 


















Anonymous said:
for the love of God, someone do something about this and before they get the paper shredders going!
Click to expand...

My guess is that the paper shredders have already cooled. And the proper paperwork has somehow surfaced to fill the void of nonexistent and incomplete files. If this company didn't get caught this time, it's only a matter of time before something else boils over. You can't operate in such a sloppy manner and not get caught somewhere along the line. It happened to BP!
 






Is this for real ?

Or just some lying woman rep who wants to sink more this respectful and compassionate company ?

If you KNOW all that dirt......why only post a few words....????

We WANT TO READ MORE !!!!
WHO is truly behind this ?!
 






Anonymous said:
All this is correct...

Basel is running scare....everyone is completing all their SOPs readings and sign-off....which have not been done for years !!!!

Everyday there is an email about this topic....

They are under big pressure to get all done, before going to the FDA.

Does anyone has anymore info on the subject ?
Click to expand...

DSM messed up big. Some manager was let go already. They are cleaning up records in past several years.
 












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