Warner Chilcott Gets A Subpoena For Bribery

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Warner Chilcott Gets A Subpoena For Bribery
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By Ed Silverman // February 28th, 2012 // 8:00 am


File this under ‘what did they do right?’ Put another way, Warner Chilcott may have done just about everything wrong. Consider that Warner Chilcott and some ‘non-executive employees’ in the sales division last week received a subpoena from the US Attorney in Boston for a wide array of activities.

To wit, the feds want info and documents on “sales and marketing activities, payments to people who are in a position to recommend drugs, medical education, consultancies, prior authorization processes, clinical trials, off-label use and employee training (regarding laws and regulations about off-label info and physician remuneration)…,” according to a filing with the US Securities and Exchange Commission (which you can read here on page 41).

What’s more, the feds want this information pertaining to “current key products.” What are the key products? These would include the Actonel med for osteoperosis; the Doryx antibiotic; the Asacol treatment for ulcerative collitis; the Loestrin and Femcon oral contraceptives, and the Enablex drug for overactive bladder (here is the complete product line up). In other words, just about every sales and marketing activity is now being probed.

This is not the first time that a federal agency has scrutinized the Warner Chilcott sales and marketing team for going its own way. Last year, a sales rep posted her own promotional video on You Tube and did so at the direction of her district manager. We know this because the FDA sent a letter to Warner Chilcott saying the video was the subject of a Bad Ad complaint (back story).
 






Finally Rogers buy the business philosphy is catching up to WC. The scams Roger implemented are going to be the down fall of WC. Keep giving out field cash, preceptorships and spouce dinners OIG is coming in be ready
 


















Bribery is the least of their worries. How about HIPPA violations, forgery of signatures, reps filling out PA forms at the direction of Roger B. and Carl R. Being rewarded for doing it. This investigation needs to be traced up the chain. It is not non-executive personnel only. They were following direction. Dig deeper OIG, FBI, and Mass Attorney General. Probe sales meetings and direction from Roger and Carl. Get every email. You will find this goes to the top. Corruption runs rampant here!
 






Anonymous said:
My manager didn't authorize what I doing or how I was spending my $15k T&E budget?

Really??

Really???
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A manager's authorization does not protect you in court. Read the Pharma code. I know this company shits on the Pharma code but they are "guidelines" which are set up by the industry as a baseline to judge ethical behavior. If you are unfamiliar with the guidelines you will become so soon.
 






Anonymous said:
A manager's authorization does not protect you in court. Read the Pharma code. I know this company shits on the Pharma code but they are "guidelines" which are set up by the industry as a baseline to judge ethical behavior. If you are unfamiliar with the guidelines you will become so soon.
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No one is bound by the "PHRMAcode except those that voluntarily do so, as part of an organization called "PHRMA". This "code" has NO legal standing, and no one is legally bound to follow them. WARNER CHILCOTT IS NOT A MEMBR OF PHRMA.

Here is a list of companies that have agreed to voluntarily abide by the PHRMA code, as members of PHRMA:

http://www.phrma.org/about/member-companies
 






Anonymous said:
No one is bound by the "PHRMAcode except those that voluntarily do so, as part of an organization called "PHRMA". This "code" has NO legal standing, and no one is legally bound to follow them. WARNER CHILCOTT IS NOT A MEMBR OF PHRMA.

Here is a list of companies that have agreed to voluntarily abide by the PHRMA code, as members of PHRMA:

http://www.phrma.org/about/member-companies
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“sales and marketing activities, payments to people who are in a position to recommend drugs, medical education, consultancies, prior authorization processes, clinical trials, off-label use and employee training (regarding laws and regulations about off-label info and physician remuneration)…,” and BRIBERY is not covered in PHRMA...dumb ass
 






Anonymous said:
No one is bound by the "PHRMAcode except those that voluntarily do so, as part of an organization called "PHRMA". This "code" has NO legal standing, and no one is legally bound to follow them. WARNER CHILCOTT IS NOT A MEMBR OF PHRMA.

Here is a list of companies that have agreed to voluntarily abide by the PHRMA code, as members of PHRMA:

http://www.phrma.org/about/member-companies
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The fact that you would defend WC by not being a member of PHRMA is an indication of some nasty practices that are allowed to flourish here. Again, slower so you will understand....

Although WC is not a member of PHRMA, the code will be used as a baseline to judge what to protect them from the charges that WC now faces (and is guilty of). Not being a member does NOT protect a company from being found guilty of bribery.

Do you understand now ????
 






Anonymous said:
The fact that you would defend WC by not being a member of PHRMA is an indication of some nasty practices that are allowed to flourish here. Again, slower so you will understand....

Although WC is not a member of PHRMA, the code will be used as a baseline to judge what to protect them from the charges that WC now faces (and is guilty of). Not being a member does NOT protect a company from being found guilty of bribery.

Do you understand now ????
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I understand that you don't know what you are talking about :) I understanding that you are a drug rep and not an attorney :) I also understand that you are passing your opinion off as indisputable fact :) Now, if I'm wrong please provide us all with a link so that we can all acccss your great source of information.

Do youuuu understand now?????????????? :)
 






Anonymous said:
I understand that you don't know what you are talking about :) I understanding that you are a drug rep and not an attorney :) I also understand that you are passing your opinion off as indisputable fact :) Now, if I'm wrong please provide us all with a link so that we can all acccss your great source of information.

Do youuuu understand now?????????????? :)
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Can you read? You company has broken the LAW...

Massachusetts Enacts Pharmaceutical and Medical Device Marketing Law
Massachusetts has now joined California and Nevada in imposing marketing compliance obligations on drug and device companies marketing products in the state.* On Sunday, August 10th, Massachusetts Governor Deval Patrick signed into law Senate Bill 2863, which requires the Massachusetts Department of Public Health (DPH or Department) to establish a pharmaceutical and medical device marketing code of conduct, and imposes compliance and reporting requirements on pharmaceutical and medical device companies that employ a person to sell or market prescription drugs or medical devices in Massachusetts.* The law will become effective on January 1, 2009.* It does not apply to wholesale drug distributors or retail pharmacies.
The law requires the DPH to establish a marketing code of conduct that is no less restrictive than the most recent versions of the Codes on Interactions with Healthcare Professionals issued by the Pharmaceutical Research and Manufacturers of America (the PhRMA Code) and the Advanced Medical Technology Association (the AdvaMed Code).* As we reported in June, the PhRMA Code was recently revised to add more stringent restrictions on meals, gifts, and other drug marketing activities.
Under the statute, the DPH marketing code must contain specific prohibitions, some of which are more restrictive than the revised PhRMA Code.* For instance, the DPH marketing code may not allow a pharmaceutical or device manufacturing company to provide meals that are part of a recreational event, offered without an informational presentation, consumed outside of the office, or for a practitioner’s spouse or other guest.* The PhRMA Code, in contrast, permits a drug company to provide meals outside the professional’s office if they are not provided by field representatives or their immediate managers.* The DPH code must also prohibit the sponsorship of independent medical education programs that do not meet the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support, whereas the PhRMA Code permits support for non-ACCME accredited third-party programs.* The DPH code must, like the PhRMA Code, prohibit the provision of entertainment or recreation.* In addition, the Code must prohibit all payments to healthcare practitioners, except as compensation for bona fide services.* This latter provision is drafted broadly enough to prohibit rebates and other price reductions offered after a purchase.* Hopefully, the DPH will clarify that price reductions are not affected by the code.
The law also spells out certain activities that must be permitted under the marketing code.* The code must allow companies to distribute peer reviewed scientific information; purchase advertising in peer reviewed scientific journals; provide pharmaceuticals exclusively for use by the practitioner’s patients; compensate a practitioner for consulting services in connection wth genuine research or a clinical trial; and pay reasonable expenses in connection with medical device training if those expenses are part of the purchase contract.
The law does not impose a deadline for the development of the marketing code, but once it is established, the DPH must update it at least every two years.
Under the new law, drug and device companies that employ a person to sell or market a prescription drug or medical device in Massachusetts must adopt and comply with the DPH’s most recent marketing code of conduct; adopt a training program for compliance with the code; conduct annual audits to monitor compliance with the code; and adopt policies and procedures for investigating noncompliance with the code.* In addition, these companies must take corrective action in response to noncompliance with the code, and report any noncompliance to state authorities.
The law also requires covered drug and device companies to provide two annual reports to the Department.* The first report will include a description of the company’s training program, a description of the investigation policies, information on the compliance officer, and a certification that the company has conducted its annual audit and is in compliance with the DPH marketing code.* The annual deadline for this report is not specified.
Second, by July 1 every year, a covered drug or device company must also report the “value, nature, purpose and particular recipient” of any payment, fee, or economic benefit of at least $50 it provided to a physician, hospital, nursing home, pharmacist, or other specified healthcare practitioner.* The Department will then make such information available on its website.* Notably, unlike the reporting laws of other states, there are no exceptions to this reporting obligation for bona fide service fees, investigator payments, or any other payments.
The law, which will be enforced by the Attorney General, provides for a fine of up to $5,000 for each transaction, occurrence, or event that violates this law.
By Bryon F. Powell & Alan M. Kirschenbaum
Posted at 09:53 AM in Drug Development | Permalink
 






Do you understand that PhRMA guidelines are just that, guidelines - not laws. If one's actions do not conform to the guidelines - but don't constitute a crime - BFD- what do you get? A fine if your company is a member? Zilch if not a member? Bribery is a crime; anyone found guilty of that better look good in stripes (or orange).
 


















Anonymous said:
MA doesn't allow Med Eds. It is not voluntary PHRMA guidelines that were broken...it applies to all pharmaceutical and device companies in MA...you guys are screwed
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Not to mention the attention this will get from the OIG which is not bound by the PhRMA code and its members, ever hear of laws governing Kickbacks?
 












Anonymous said:
Do you understand that PhRMA guidelines are just that, guidelines - not laws. If one's actions do not conform to the guidelines - but don't constitute a crime - BFD- what do you get? A fine if your company is a member? Zilch if not a member? Bribery is a crime; anyone found guilty of that better look good in stripes (or orange).
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To clarify, some state laws (such as CA and MA) require compliance to PhRMA guidelines. So companies having reps in these states must follow PhRMA guidelines regardless of whether they are members of PhRMA or not.

http://www.winston.com/siteFiles/publications/Snapp10-31-08Law360article.pdf
 
























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