As part of an $81 million off-label settlement with the Department of Justice (DOJ), Ortho-McNeil Janssen Pharmaceuticals Inc. (OMJPI) sales reps will be buddied up with internal compliance monitors tasked with observing and reporting on the rep’s behavior out in the field.

The measure, one of several listed in OMJPI’s 70-page Corporate Integrity Agreement (CIA), stipulates that randomly selected “full day ride-alongs” be conducted across “each therapeutic area and actively promoted product…across the United States.” The observations “consist of directly observing all meetings between a sales representative and HCPs…during the workday,” according to a transcript of the CIA published yesterday at The Office of Inspector General (OIG) made the document available to MM&M today.

After an observation, compliance observers must file a report including the following items:

  • identity of the sales representative
  • identity of the OMJPI compliance professional
  • date and duration of the observation
  • product(s) promoted during the observation
  • overall assessment of compliance with OMJPI policy
  • identification of any potential off-label promotional activity by the field sales representative

Any observations that uncover instances of improper promotion by a rep must be filed with the OIG on an annual basis, under the CIA.

Greg Panico, a J&J spokesperson, said in a message that rep ride-alongs are “part of our existing policy. While it is indeed part of the CIA, we already do that. There is management oversight of our reps.”  Panico said the company did not report rep observations to the OIG prior to the CIA.   

Other stipulations of the CIA include a mandatory three-hours of training for sales reps on regulatory law and the penalties for violations, as well as the hiring of an independent review organization to help assess and evaluate OMJPI promotional activities.

Paid speakers for the company will need to sign written agreements describing the scope of the work performed, fees paid, and compliance obligations. Speaker programs must also be tracked “through a centralized, electronic system that includes controls…designed to ensure that speaker programs are used for legitimate and lawful purposes” under the CIA.    

Once executed, the CIA will stay in place for five years. Penalties ranging from $1,000 to $5,000 (per day) will be assessed by the OIG for any failure to comply with specific reporting measures detailed in the document.

The $81 million settlement and CIA are the result of a qui tam, or whistleblower, lawsuit, that alleges J&J’s OMJPI unit marketed Topamax, a migraine and epilepsy drug, for off-label psychiatric uses under a program called “Doctor-for-a-Day, according to a DOJ release.

AstraZeneca recently settled a similar whistleblower off-label case regarding its drug Seroquel, an antipsychotic. That case cost AstraZeneca $520 million, and a CIA agreement, which also included the “ride-along” provision. An Eli Lilly CIA created as part of an off-label settlement over Zyprexa last year includes ride-along observers, as does Pfizer’s CIA, which resulted from a $2.3 billion Bextra off-label settlement.