And so the drugmaker is blaming an outside party for a failure to respond to employees who complained about alleged instances of off-label marketing. AstraZeneca released a memo marked “Privileged & Confidential” to employees two days ago in the wake of the newsletter scandal that erupted last month.

The newsletter, which circulated on this site and others, contained a remark by an oncology regional sales manager, who called doctors’ offices a “big bucket of money,” and alluded to off-label marketing practices. Then anonymous employees circulated company material alleging marketing violations. AstraZeneca already operates under a Corporate Integrity Agreement

Earlier this week, Pete Stark, a Democratic congressman who heads the health subcommittee of the House Ways and Means Committee, wrote the HHS Office of Iinspector General to urge an investigation. The OIG has indicated it will review the results of the drugmaker’s own internal investigation, which it concluded this week by saying disciplinary action was taken, but few detais were actually provided.

Here are excerpts from the memo, courtesy of Question Authority, that blames a compliance vendor for a failure in responding to the drugmaker’s whistleblowers:

“May 2, 2007 - AstraZeneca is committed to patient health - it’s what the company is founded on, and it’s what drives the people who work here. We know that employees act in a manner that’s consistent with our company’s dedication and commitment to the health and welfare of patients. When we hear differently, we take the necessary steps.

We recently received compliance reports through the AstraZeneca Code of Conduct Helpline from employees regarding oncology-related science data. AstraZeneca takes claims of compliance violations very seriously, and immediately initiated the investigation process to better understand the allegations, their validity and potential impact.

We felt it was important to circle back with you so you could know the results of these internal events that made their way into the external environment.

We have concluded our investigation on several of these claims and have taken corrective action, when appropriate. In some cases, there was merit to the allegations and appropriate disciplinary action has been taken. Our investigations also revealed that a number of the allegations were either unsubstantiated or a result of misunderstanding. We underscore that we do no tolerate retaliation against people who raise legitimate issues and that we found no credible evidence for that here.

We subsequently became aware of a systems issue with our prior Helpline vendor. Some employees who had reported suspected violations were prevented from receiving the information that AZ had provided as a follow-up to their reports. We address the systems issue as soon as we discovered it, and we do not expect it to recur. Responding promptly and appropriately to reported violations is a fundamental element of our compliance program.

Through this investigation we have identified at least three overall learnings that we can apply to uphold an ethical culture.

First, we took this opportunity to reiterate will all employees the importance of adhering to the highest ethical standards of all our compliance policies. The corporate compliance training has just begun its annual cycle, and you can expect more communications that highlight training, key messages and resources that are available.

Second, we recognize both training and the application of training are necessary to foster and ethical culture. It requires a deliberate commitment by every employee to live up to the standards we set forth as an organization. Employees need to use the established processes to attain approval on marketing, promotional and sales training materials (AZAP) and other communications for internal and external presentations. We cannot let our guard down, forget a step, or even bypass a process for expediency sake.

Finally, and most important, we will continue to communicate to employees our focus on the health of patients as our number one priority at AstraZeneca. When we are committed to working with physicians to ensure that the right medicines are delivered to the right patient at the right time, we will attain our patient metric goals and reach our business targets.

Hat tip to Question Authority
[tags]AstraZeneca, Mike Zubillaga, Off-Label Marketing[/tags]