The drugmaker issued a statement just now saying that the ‘newsletter scandal,’ in which anonymous employees alleged that sales managers and reps engaged in illegal off-marketing of cancer meds, is completed. And there was “merit to the allegations” in some cases. Moreover, disciplinary action has been taken, but there were no details provided about the number of people involved, their employee rank or the specific violations uncovered. So for the moment, there is no way to verify the extent to which the company has actually taken action.

AstraZeneca went on to say that there were also allegations that were either “unsubstantiated or a result of misunderstanding.” And while the company insists that retaliation isn’t tolerated, there was “no credible evidence” any took place as part of this scandal, which began last month when Internet sites, including this one, posted an internal newsletter quoting a sales manager saying doctors’ offices are like a “big bucket of money,” and alluding to off-label practices. The sales manager, Mike Zubillaga, was fired the day after the disclosure. Later, anonymous employees wrote Pharmaot and others with allegations of off-label marketing.

The drugmaker says that it has “voluntarily committed to share the results” of the investigation with the HHS Office of Inspector General. AstraZeneca has no choice - it operates under a 2003 Corporate Integrity Agreement. The OIG is already aware of this episode, and Congressman Pete Stark, a Democrate who heads the health subcommittee of the House Ways and Means committee, last week wrote the OIG asking for an investigation.

In other words, the ‘newsletter scandal’ may not be over. That would depend on what, if any, action the OIG takes after reviewing whatever AstraZeneca forwards. Today, OIG spokesman Don White told Congressional Quarterly: “At this point, there is just a preliminary evaluation going on (in response to Stark’s letter). I’m not going to make any comment on an ultimate conclusion of a review. We have no indication that there is any kind of breach - we just don’t know yet. We don’t have hard info.”

Here is the key portion of the AstraZeneca statement sent to Pharmalot:

“We have concluded our investigation of the claims arising from the newsletter and other reports. In some cases, there was merit to the allegations and appropriate disciplinary action has been taken. Our investigation also revealed that a number of the allegations were either unsubstantiated or a result of misunderstanding. We underscore that we do not tolerate retaliation against people who raise legitimate issues and that we found no credible evidence for that here. These claims involve personnel matters. We will not disclose the specific outcomes for confidentiality reasons. We have voluntarily committed to share the results of our investigation into these claims with the OIG.

“As we progress as a company, we will also look for ways to make our processes even better. To this end, we have reiterated with all employees the importance of adhering to the highest ethical standards of all our compliance policies. We are also in the process of launching enhanced systems to make it easier than ever before for employees to obtain guidance on compliance issues, and to report suspected violations and receive information on our follow-up and response to those reports.”

You can read the Congressional Quarterly dispatch here (subscription required)[tags]AstraZeneca, Mike Zubillaga, Off-Label Marketing[/tags]