Pharmaceutical Compliance Cops to Ride Along With Sales Reps

By May 18, 2010 Drug Safety

A recent $81 million settlement between the Department of Justice and Johnson & Johnson’s Ortho-McNeil Janssen Pharmaceuticals Inc. means sales reps for the company will be monitored with compliance cops who will observe and report on the representatives’ behavior on the job.

The measure, part of a Corporate Integrity Agreement, calls for randomly-timed, full-day observational ride alongs, encompassing all therapeutic products and programs for the company. The compliance officials will observe all meetings the sales representative conducts during their work day.

Observations will end in a formal report, including the identities of the sales representative and the compliance professional, the date and time of the observation, any products promoted during the event, an assessment of the degree of the representative’s compliance with Ortho-McNeil’s policies and identification of any off-label promotional activity.

Specifically, any cases of improper promotion must be rigorously reported to relevant officials on an annual basis. Johnson & Johnson stated that ride along observations were already part of policy, but were simply not reported prior to the current agreement.

Other regulations will apply to sales representatives as well. They will require three hours of training on regulatory law and its penalties, as well as signing statements describing the scope of the work they are permitted to perform. The agreement also mandates a centralized system that tracks all presentation engagements by Ortho-McNeil personnel.

This agreement has been scheduled to remain in place for a five-year period. Violations and failures to comply will range from $1,000 to $5,000 dollars per day, depending on the severity of the infraction.

The primary aim of the agreement is to protect consumers from gross misrepresentation of products such as the controversial antibiotic Levaquin, a specific Johnson & Johnson brand. Promotional officials will not be permitted to downplay the serious potential risks in J&J products under this agreement.