J&J Sales Reps Must Ride With Compliance Police
20 CommentsBy Ed Silverman // May 5th, 2010 // 8:27 am
This is the sort of supervision that sales reps just can’t stand. As part of the $81 million settlement that two Johnson & Johnson units paid to resolve criminal and civil lawsuits over illegally promoting the Topamax epilepsy drug, J&J’s Ortho-McNeil compliance personnel must ‘ride along’ with reps and “directdly observ(e) all meetings” between reps and health care providers.
“The observations shall be scheduled throughout the year, randomly selected by compliance personnel and other appropriately trained (compliance) representatives as described above, include each therapeutic area and actively promoted product, and be conducted across the United States,” according to the Corporate Integrity Agreement that was part of the settlement.
And once the ride is over, the compliance police must file a report identifying the rep; the date and duration of the observation; the product(s) promoted; an overall assessment of compliance with policy, and the identification of any potential off-label promotional activity by the rep. Presumably, reps will be on their best behavior? But who monitors the monitors? You know, what if they go out for a beer after a hard day riding together to visit countless hard-to-pigeonhole docs?
The CIA attempts to address this by stipulating that sales reps must endure a mandatory three-hours of training on regulatory law and the penalties for violations, as well as the hiring of an independent review organization to help assess and evaluate promotional activities. Good luck to all.
Hat tip to MM&M
Matthew Holford
I’ve got a better idea: compliance staff and reps should change positions, and do one another’s jobs for at least a year.
Matt
pharmavet
Is this the Full Employment Act for the compliance police? With thousands of reps I don’t see how it is even remotely possible to accomplish this task in any kind of efficient manner. Next thing will be the food police to tell the reps how many and what kind of toppings to put on the rep-catered pizzas. Why not start with self-policing, using the DM’s, who have more to lose than the reps if the rep is non-complaint. If self-regulation doesn’t work then go to the next level. Even Wall Street was allowed to try self-regulation before the congressional economic geniuses like Carl Levin and Chris Dodd decided to tighten the screws on the banks (and probably plunge us into a double-dip recession, but that’s a discussion for another day).
Tobias
Why didn’t they do this when Topamax was being promoted for weight loss? Everyone knew it was being promoted for everything under the sun. Everything is done after the fact.
JaT
Taking an epilepsy med for weight loss, simply because it happens to have that effect, is like eating a candy bar instead of a banana- simply because it also happens to be sweet.
Big Pharma Watch
It’s the price you pay when you can’t follow the rules!
nicola.hill@wolterskluwer.com
The regualtory environment is just a little bit tough right now!
Regards,
Phil
Charlie Foxtrot
Even better, maybe compliance should sit down with upper execs who give the directives that filter down to the reps on what they are to detail their docs?
SteveM
The compliance guys would be happy because they’d only have to work the reps schedule - 2 hours a day and time out for golf.
M. Black
A three hour training?
A three hour training??
A THREE HOUR TRAINING??????
Are you kidding me?? Are these coaching session on how to act in front of an auditor, or valid training about how to do their jobs correctly, whether being audited or not. Employees in almost all positions in pharma should be doing their jobs as if someone is auditing compliance activities. Heck, inside a plant, there are so many cameras, that pretending is not all that necessary.
THREE HOUR &$&(&@$)(& TRAINING??????????
M T
Based on decades in the industry, I suggest that the compliance officers need to spend a bit of time with the district and regional managers, as well as the reps. The pressure on the reps to achieve sometimes unrealistic sales goals flows downhill from the managers above. Often, there is an unspoken, yet clearly communicated attitude of “just get it done”, which can be filtered down through the chain of management to the field reps.
Ken Schields
It’s nothing more than a joke and insult to any American with half an ounce of gray matter. Another oxymoron for the health care dictionary - Corporate Integrity Agreement. It’s as bad as banning lunches and trinkets for the docs.
I also can’t believe most of the previous comments. Are the actually taking this seriously?
Jackson Roe
Compliance police here. The sales rep is always the scape goat. Upper management, marketing and the vps of the company are the ones that continually get away with indiscretions and violations. The reason being is that is they did get caught, the company would be held liable for even more money and individuals would definitely go to jail. This system has been in place for awhile, and it exists in every industry.
SteveM
The idea that the storied American Pharmaceutical Houses now have the corporate integrity of a Chinese dry wall company is actually phantasmagorical.
Rita Booke, M.D.
it is about time these reps are monitored. I have seen nothing but dishonest reps comebad through my office giving me information. I don’t leyt reps in my office anymore. I think the industry should get rid of reps so there wouldn’t be any more problems like this.
Former Pharma
I think the compliance police should go into the board room and meet with the out-of-control CEOs and top executives. These are the chiefs that order the indians around. The fish stinks from the head down! people with ehtics and integrity are quickly dismissed from Big Pharma because they “destroy” business opportunities!
M. Black
Hey Matthew (first post),
Us “compliance folks” would love to come home at 2PM to catch a baseball game instead of chasing goons around until 6.
Cry me a river.
MB
M. Black
You know, the shipping business in the US has been flapping around like fish out of the water. In line with Dr. Brooke’s comment, and sad to
say for my personal rep friends, the position as it stands today is more useless than not. I’ve had Topamax mentioned to me as a weight loss substance by a doctor before. I’ve never taken nor used Topamax.
Pharma sales reps could be replaced by the US Postal System and the like. I don’t think all reps are unethical, but with their sales background, they will be able to find another sales job.
My honest take…
MB
TB
What a load of rubbish! I expect every report to come back clean. A rep would have to be a moron to do anything stupid while being monitored and guess what? reps are street smart which is why they get into sales. This is like having the police accompany a convicted shoplifter to a store every once in a while to see if they shoplift. I bet the shoplifter would pass every time.
pharmavet
This compliance thing is a joke. I can think of at least 10 different ways that a rep could convey false and misleading information to a doctor, not leave a trace of evidence behind, thereby not trigger the need for a ride-along.
Pam
I was given Topamax for pain management for nerve entrapment. This stuff was the most HORRIFIC drug I’ve ever experienced. It messes with your mind. You repeat yourself. You can’t remember, when looking from side to side at a stop sign, what you just observed. You just sit there looking left, right, left, right. My co-workers approached me and asked me to stop using Topamax. I got violent stomach pains when I took my pills. I, too, was told weight loss was a “benefit” and now I know why. All I could eat was a bowl of oatmeal. And they give this stuff to CHILDREN? I’m outraged. I wasn’t even followed up with by my physician. I took myself off the meds by reducing by 1 pill every 2 days, just as they had been increased (to 8 pills at one sitting once a day as prescribed by my doctor). This drug should be REMOVED.