# of compliance attorneys

[Anonymous]

How many attorneys on average do the big pharma companies have? I would say too many but I was looking for a rough estimate.

 

[Anonymous]

Perhaps it's more an issue of quality, not quantity. Maybe that explains why more & more companies are being investigated & then fined by the gov't.

 

[Anonymous]

like hiring folks like Clive at UCB, a token hire if I ever saw one.

 

[Anonymous]

Perhaps it's more an issue of quality, not quantity. Maybe that explains why more & more companies are being investigated & then fined by the gov't.

Let’s be honest, some of our S&M colleagues may have pushed the limits or even gone beyond promotion according to the approved label. But who should be held accountable, the sales rep or the managers who created this environment? Dissemination of articles not reflective of the approved label, although allowed certainly raises questions. The speakers programs, lots of CME, numerous industry supported conferences (some of which were completely redundant and other absolute junk) resulted in a substantial amount of money being directed to health care professionals. More than a few cars, mortgage and college tuition payments have been made from income derived from the pharmaceutical and biotechnology industry. A medical community which has no restriction on prescribing for non-approved indications and in some cases physicians received financial benefit for medications administered in their offices based on the “spread” between the acquisition cost and the actual reimbursement of the medication; all of these items along with a zealous group of government enforcement agencies has gotten our industry to this point.

Whether you like your compliance group or not, whether your company has good or bad compliance attorneys, everyone needs to wake up. The environment has gotten a lot more conservative, deal with it! The next round of enforcement actions will not only include fines and disbarment, but a couple of our more recalcitrant colleagues may be spending time in a federal institution. Disbarment and incarceration are the biggest concerns to many of the industry's executive officers. The next wave of investigations will be closely examining our medical affairs and R&D activities. With the past investigations as examples and enhanced enforcement of the foreign corrupt practices act, the UK anti-bribery law, etc., a good compliance group should be one of your closest business partners.

 

[Anonymous]

Let’s be honest, some of our S&M colleagues may have pushed the limits or even gone beyond promotion according to the approved label. But who should be held accountable, the sales rep or the managers who created this environment? Dissemination of articles not reflective of the approved label, although allowed certainly raises questions. The speakers programs, lots of CME, numerous industry supported conferences (some of which were completely redundant and other absolute junk) resulted in a substantial amount of money being directed to health care professionals. More than a few cars, mortgage and college tuition payments have been made from income derived from the pharmaceutical and biotechnology industry. A medical community which has no restriction on prescribing for non-approved indications and in some cases physicians received financial benefit for medications administered in their offices based on the “spread” between the acquisition cost and the actual reimbursement of the medication; all of these items along with a zealous group of government enforcement agencies has gotten our industry to this point.

Whether you like your compliance group or not, whether your company has good or bad compliance attorneys, everyone needs to wake up. The environment has gotten a lot more conservative, deal with it! The next round of enforcement actions will not only include fines and disbarment, but a couple of our more recalcitrant colleagues may be spending time in a federal institution. Disbarment and incarceration are the biggest concerns to many of the industry's executive officers. The next wave of investigations will be closely examining our medical affairs and R&D activities. With the past investigations as examples and enhanced enforcement of the foreign corrupt practices act, the UK anti-bribery law, etc., a good compliance group should be one of your closest business partners.

Couldn't agree more. I'm usually one of the people that companies bring in AFTER the investigation or settlement has started or is in place. The reason why there are so many compliance professionals in some of these companies? Many employees work harder to fight compliance initiatives as opposed to making the policies fit in their work lives.

My latest assignment has been pretty shocking. Many people have been lucky to not (yet) walk away in handcuffs. No respect for policies. No respect for government officials. No respect for anything. In today's climate, too many people think that compliance will just go away or be fired if sales are effected. That hasn't happened. Instead, compliance is still around and the people not with the program are gone.

I agree with your assessment regarding clinical trials and R&D. Those are under great scrutiny at both the consultant/site level and the sponsor level. It's low hanging fruit for investigators and a potential area of substantial abuse.

Why not spend the time learning the policies and procedures? When I know that a policy needs to change, I will often bring in the business people who follow the current policies. Through effective communication, I can work with those business people to develop policies that work for them while maintaining a compliant company.

 

[Anonymous]

Couldn't agree more. I'm usually one of the people that companies bring in AFTER the investigation or settlement has started or is in place. The reason why there are so many compliance professionals in some of these companies? Many employees work harder to fight compliance initiatives as opposed to making the policies fit in their work lives.

My latest assignment has been pretty shocking. Many people have been lucky to not (yet) walk away in handcuffs. No respect for policies. No respect for government officials. No respect for anything. In today's climate, too many people think that compliance will just go away or be fired if sales are effected. That hasn't happened. Instead, compliance is still around and the people not with the program are gone.

I agree with your assessment regarding clinical trials and R&D. Those are under great scrutiny at both the consultant/site level and the sponsor level. It's low hanging fruit for investigators and a potential area of substantial abuse.

Why not spend the time learning the policies and procedures? When I know that a policy needs to change, I will often bring in the business people who follow the current policies. Through effective communication, I can work with those business people to develop policies that work for them while maintaining a compliant company.

Well said! From a field sales perspective having respect for and implementing policies is essential. Over the years I have encountered many, both managers and sales reps, who wanted nothing more that to navigate around company policies in order to somehow gain more sales, and thus be recognized at those awards dinners.

 

[Anonymous]

like hiring folks like Clive at UCB, a token hire if I ever saw one.

I agree with you that Clive is a token. He was brought in by UCB specifically because the company wanted to pay lip service to having a compliance program, and an AA hire was a good place to beef up minority numbers at the company and possibly stave off an EEOC action.

 

[Anonymous]

Anybody ever think that the regulations and laws are overreaching and idiotic?

Maybe getting rid of these free market restrictions and very likely unconstitutional, should be job #1?

 

[Anonymous]

As rep, I have no problem with these regulations. My company pays me to sell using FDA- approved clinical studies. I am highly trained and work very hard to build appropriate business relationships. I don't believe that dinners sell, and quite honestly, I don't get paid to work the extra evening hours and it costs me $50 out of my own pocket to hire a babysitter for my kids while I'm working until 10PM. I just wish my competitiors took all of this seriously so I don't end up constantly appearing like the "bad guy".

 

[Anonymous]

Let’s be honest, some of our S&M colleagues may have pushed the limits or even gone beyond promotion according to the approved label. But who should be held accountable, the sales rep or the managers who created this environment? Dissemination of articles not reflective of the approved label, although allowed certainly raises questions. The speakers programs, lots of CME, numerous industry supported conferences (some of which were completely redundant and other absolute junk) resulted in a substantial amount of money being directed to health care professionals. More than a few cars, mortgage and college tuition payments have been made from income derived from the pharmaceutical and biotechnology industry. A medical community which has no restriction on prescribing for non-approved indications and in some cases physicians received financial benefit for medications administered in their offices based on the “spread” between the acquisition cost and the actual reimbursement of the medication; all of these items along with a zealous group of government enforcement agencies has gotten our industry to this point.

Whether you like your compliance group or not, whether your company has good or bad compliance attorneys, everyone needs to wake up. The environment has gotten a lot more conservative, deal with it! The next round of enforcement actions will not only include fines and disbarment, but a couple of our more recalcitrant colleagues may be spending time in a federal institution. Disbarment and incarceration are the biggest concerns to many of the industry's executive officers. The next wave of investigations will be closely examining our medical affairs and R&D activities. With the past investigations as examples and enhanced enforcement of the foreign corrupt practices act, the UK anti-bribery law, etc., a good compliance group should be one of your closest business partners.

"good compliance group should be one of your closest business partners."

What a douche. You a-wipes haven't a clue how difficult you make peoples lives. We are out working our butts off, so you pukes can sit in your office and type b.s. memo's. I've dealt with one compliance atty at Genzyme. Sleaze-ball extraordinaire. They tell us what we can't say, yet when we ask questions on how we solve the problems caused by the new "rule", ................nothing. Not so much as a clue how we explain things. A-holes........all of you..including H.R. managers. Completely useless........I would throw in a c-bomb here, but my post would get deleted.

 

[Anonymous]

"good compliance group should be one of your closest business partners."

What a douche. You a-wipes haven't a clue how difficult you make peoples lives. We are out working our butts off, so you pukes can sit in your office and type b.s. memo's. I've dealt with one compliance atty at Genzyme. Sleaze-ball extraordinaire. They tell us what we can't say, yet when we ask questions on how we solve the problems caused by the new "rule", ................nothing. Not so much as a clue how we explain things. A-holes........all of you..including H.R. managers. Completely useless........I would throw in a c-bomb here, but my post would get deleted.

I have a detailed undeerstanding on how difficult it is to operate in the new compliance environment, I wrote the note you quoted and I am subject to the same compliance requirements that you are. I would assume that the hundreds of millions of dollars in fines that our industry has had to pay over the past couple of years are ok with you? And that you are ok that the credabiltiy and public trust in the pharmaceutical and biotechnology industry is at an all time low. Yes some of our compliance officers and HR staff can be over the top and this needs to be fixed. But since you understand the rules and how the various state and federal government agencies are scrutinizing our actives whether they be on the S&M side or the R&D side, what are your suggestions and solutions to the problems and issues? Business as usual, with more 500 million dollar settlements? Perhaps when they start criminal prosections in earnest (e.g. individual sales reps and DSMs) and disbarment is on the horizon you will realize the seriousness of this effort.

 

[Anonymous]

"good compliance group should be one of your closest business partners."

What a douche. You a-wipes haven't a clue how difficult you make peoples lives. We are out working our butts off, so you pukes can sit in your office and type b.s. memo's. I've dealt with one compliance atty at Genzyme. Sleaze-ball extraordinaire. They tell us what we can't say, yet when we ask questions on how we solve the problems caused by the new "rule", ................nothing. Not so much as a clue how we explain things. A-holes........all of you..including H.R. managers. Completely useless........I would throw in a c-bomb here, but my post would get deleted.

So what is your opinion about the Department of Justice 1.8 billion dollar demand to J&J regarding the Risperdal settlement? Your so called douche, a-wipes and pukes did not create this mess and the litany of other settlement problems and crimal actions. A few of your moronic S&M colleagues were responsible. The day is not far off when perhaps a few of your collegues will be spending some time in a federal facility.

 

[Anonymous]

"good compliance group should be one of your closest business partners."

What a douche. You a-wipes haven't a clue how difficult you make peoples lives. We are out working our butts off, so you pukes can sit in your office and type b.s. memo's. I've dealt with one compliance atty at Genzyme. Sleaze-ball extraordinaire. They tell us what we can't say, yet when we ask questions on how we solve the problems caused by the new "rule", ................nothing. Not so much as a clue how we explain things. A-holes........all of you..including H.R. managers. Completely useless........I would throw in a c-bomb here, but my post would get deleted.

Hey douche what do you think about the announcement below, please pay attention to the criminal fine. Next stop is some of our sales and marketing colleagues get sent to a federal prison. That would shape things up quickly.

Johnson & Johnson, US prosecutors reach settlement up to $2.2 billion over company's marketing practices: (Ref: The Wall Street Journal, The Washington Post, NASDAQ)
July 19th, 2012. Citing sources familiar with the matter, The Wall Street Journal reported Thursday that Johnson & Johnson concluded an agreement with the US Department of Justice for up to $2.2 billion, resolving probes into the company's drug marketing practices. The final amount, which includes a criminal fine of about $400 million for the illegal promotion of Risperdal (risperidone), will depend on which US states suing the drugmaker sign on to the agreement, the sources said.

 

[Anonymous]

Hey douche what do you think about the announcement below, please pay attention to the criminal fine. Next stop is some of our sales and marketing colleagues get sent to a federal prison. That would shape things up quickly.

Johnson & Johnson, US prosecutors reach settlement up to $2.2 billion over company's marketing practices: (Ref: The Wall Street Journal, The Washington Post, NASDAQ)
July 19th, 2012. Citing sources familiar with the matter, The Wall Street Journal reported Thursday that Johnson & Johnson concluded an agreement with the US Department of Justice for up to $2.2 billion, resolving probes into the company's drug marketing practices. The final amount, which includes a criminal fine of about $400 million for the illegal promotion of Risperdal (risperidone), will depend on which US states suing the drugmaker sign on to the agreement, the sources said.

Guess none of you have every been in charge of a brand or business unit to feel what it is like to have the EVPs and CEOs breathe down your neck if the forecast are not high enough. You get accused of not believing in the brand, so the pressure is on to overforecast so that the meeting with analysts can be happy. CEOs get compensated by the stock performance so have the pressure to pump up the value of each branded drug. It's all a nasty vicious circle and sales reps and lowly brand managers are the foot soldiers who are expected to make it happen.