If you could ask one question.....

[Anonymous]

I have heard this argument before and I don't buy it at all. We are spoiled to had been exposed to good leadership and business practices?? What made Shire a great place to work for so long is that it WASN'T big pharma. In the past few years, the people who built this company have been phased out and big pharma people were hired and are now in control. Now, they are employing the practices that you call "the norm".

And for what?? They feel that Shire needed poor leadership to lose the trust of it's salesforce which have been a huge reason for the success of this company? Good luck justifying that one. I know that they love to get up on stage with their little nightclub outfits and smile and tell you a bunch of BS like everyone can't se right through it, but it is really sad to see what this company has become.

^^^^ Couldn't have said this any better! Look at the track record of our Senior leaders including Yasick, Bonnell, Clarissa. What have they done at their previous "big pharma" companies before coming to Shire?

 

[Anonymous]

Don't you think that just maybe some of the people no longer employed at shire might be due to the investigation? Hello compliance! The company is trying to do the right thing to avoid massive fines.

This might quite possibly be the most ignorant statement ever! Do you think that by forcing people who would not buy in to the style of this current leadership, we are avoiding massive fines? The FDA doesn't care who is leading the company, they are fining the company for past actions.

 

[Anonymous]

This might quite possibly be the most ignorant statement ever! Do you think that by forcing people who would not buy in to the style of this current leadership, we are avoiding massive fines? The FDA doesn't care who is leading the company, they are fining the company for past actions.

You are an idiot who has not been in the industry that long to understand the FDA...they will fine you worse if you have not followed through with their recommendations...usually those recommendation will include getting rid of the leadership who allowed this to go on...recommendations also include sending in marketing material to see if you have a handle on the sales force, compliance with sampling, etc.

 

[Anonymous]

You are an idiot who has not been in the industry that long to understand the FDA...they will fine you worse if you have not followed through with their recommendations...usually those recommendation will include getting rid of the leadership who allowed this to go on...recommendations also include sending in marketing material to see if you have a handle on the sales force, compliance with sampling, etc.

The FDA has not issued any "recommendations" to Shire. What the FDA will issue is called a Corporate Integrity Agreement which guides certain actions and mandates certain requirements and it does not include "getting rid of leadership". Currently, every piece of marketing material has to be sent to The Office of Prescription Drug Promotion (OPDP) "To protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers." It is not " to see if you have a handle on the sales force, compliance with sampling, etc".

 

[Anonymous]

Damn- someone just got served!

 

[Anonymous]

The FDA has not issued any "recommendations" to Shire. What the FDA will issue is called a Corporate Integrity Agreement which guides certain actions and mandates certain requirements and it does not include "getting rid of leadership". Currently, every piece of marketing material has to be sent to The Office of Prescription Drug Promotion (OPDP) "To protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers." It is not " to see if you have a handle on the sales force, compliance with sampling, etc".

Point I was trying to make is that if you are unethical and put the company at risk you will be let go.

 

[Anonymous]

The FDA has not issued any "recommendations" to Shire. What the FDA will issue is called a Corporate Integrity Agreement which guides certain actions and mandates certain requirements and it does not include "getting rid of leadership". Currently, every piece of marketing material has to be sent to The Office of Prescription Drug Promotion (OPDP) "To protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers." It is not " to see if you have a handle on the sales force, compliance with sampling, etc".

Unfortunately, this is not completely accurate. The actions a company takes during the period they are being investigated can impact a good faith CIA negotiations with the OIG.

 

[Anonymous]

Damn, you just got served!

 

[Anonymous]

Unfortunately, this is not completely accurate. The actions a company takes during the period they are being investigated can impact a good faith CIA negotiations with the OIG.

While this may be true, actions a company takes to prepare to negotiate the specifics of the agreement does not include firing previous leadership. Actions include internal audit committees, compliance review boards, and addressing gaps in risk mitigation. We should spend a little time learning about the industry that we work in every day!

 

[Anonymous]

From the moment a company receives a subpoena from the OIG you could make the argument the negotiation has started. There would be no negotiated CIA provisions to terminate previous leadership b/c they are already gone. However, companies who do not rid themselves of bad actor or fail to make attempts to remediate failed processes are absolutely impacted when the terms of a CIA and fines are negotiated. I would have expected someone so well versed on this topic to know this. I will go back to studying the industry I work in now.