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If doctors were taking the bribes, are they not at risk too? Is there not a code of conduct for HCPs? The whole lot of them should be subpoenaed and the book should be thrown at them all.
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
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 $5,000 for each transaction, occurrence, or event that violates this law.
By Bryon F. Powell & Alan M. Kirschenbaum
Posted at 09:53 AM in Drug Development | Permalink
did you really read it?Did you actually read this? I DID! There is NO state that incorporates the ENTIRE PHRMA Guidelines into law. There are a few that incorporate some elements of the guidelines. Bribery is against the law, and has nothing to do with guidelines.
You guys are not only screwed, but some of you are too dumb to even realize it. Payback is a b@$ch isn't it?
Worked in the MA market for WC a few years ago. Was always questioned about my lack off dinners, speakers and even lunches in my offices. I always did my best to keep my manager and RVP at arms length over the whole issue because MA does not mess around. There is a reason all MA hospitals and many large physician practices have instituted even tougher regulations that those leveraged by PHARM and state guidelines. Mass does not play with this kind of stuff!
On a positive note, I doubt any regulators will really go after individual reps, they are going to be looking to climb the ladder and hit as many people up top as possible. The higher they go the bigger the fines and they want that $$$$$. On a personal note, I felt extremely dishonest and "part of the problem" in terms of healthcare costs during my time at WC. Lasted 18 months and it felt like 5 years.
Good luck to anyone caught up in this b*llshit
I totally agree. I worked many years in pharma and always followed the law. came to WC because my family needed me to support them. I have continued to be successful doing things the right way, but get daily threats from management to do unethical and illegal things to get business. as soon as I don't finished at the top, I am gone. they have made that clear.
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).
Can YOU READ? What part of the law are your forced to violate. Please be able to provide proof(written or verbal) of a top down encouragement of law violations. If you can not do this, I really do not want to hear from you. If you feel pressured to violate the law, becuase you cant cut the mustard otherwise, that's on you. If your DM insist that you break the law, and you are stupid enough to do so, that on you. I for one have NEVER recieved any communication, insisting that I break the law, NEVER!
Why do you think WC was a voicemail based company and rarely sent e-mails. They were trying to insulate management and the executives from the illegal practices they were promoting/mandating. Harder to follow a voicemail trail than it is to follow the permanent paper trail e-mail leaves.
The dominoes are all set. Once some of the doctors start to see subpoenas and realize their livelihood is being threatened because of bribery (in the form of inappropriate payments for med ed events), the first dominoes will start to fall setting off a chain reaction.