Healthy Skepticism Library item: 17710

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
J&J Sales Reps Must Ride With Compliance Police
Pharmalot 2010 May 5
http://www.pharmalot.com/2010/05/jj-sales-reps-must-ride-with-compliance-police/

Full text:

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