So what’s happening with the compliance landscape in the US?

Wooden justice gavel and block with brassEvery year at the DIA US Med Comms conference, Monica Kwarcinski, Purdue Pharma, and Mark DeWyngaert, Huron Consulting Group, run a half day tutorial on compliance.  Inevitably they focus on the US regulatory space but, as we all know, compliance is not an topic bound by borders! For me, it’s a great refresher and a chance to see what I might have missed over the last year since I was at the last DIA US conference.


So what’s new that you really need to know about?

The hot topics are:

  • Ongoing First Amendment cases about the right to discuss off-label use of medicines and devices (Google FDA versus Amarin or download this pdf)
  • Lots of discussion about off-label use and the draft FDA guidance document from 2011 (and on the FDA agenda to be published this year – but don’t hold your breath)
  • Focus on individual responsibility and liability rather than corporate fines and sanctions. Google the “Yates memo” and the FDA “Park Doctrine” for more detail.
  • Spotlight on MSL behaviour and compliance as sales representative access to healthcare professionals is even more restricted
  • Update on how the healthcare professionals payment reporting under the Sunshine Act is working out – great source of competitive intelligence!
  • Reminder that you must be doing inquiry trend analysis to look for signals – emerging topics and possible non-compliant behaviour.
  • Notes to self about staying compliant: don’t set yourself up for failure/deviations from your compliance documentation and processes

The trend to focusing on individual responsibility was highlighted by the recent sub-poena against the former Valeant CEO to testify at a senate committee on price increases.

Call To Action

If you are in the US, you probably know what’s happening and how it relates to your job (particularly if you are well informed and read the business news).


For those of us based in Europe, breathe freely!


But observe the US compliance trends: the continued focus on off-label and what we can/cannot legitimately do.   What should you do?

  • Run an eye over your MSL activities – are their customer inquiries logged, tracked, managed and monitored?
  • If you were an inspector or auditor, where would you be looking? Is there consistency between the question and answer if the same question was answered by Medical Information versus a MSL?

And don’t forget that we audit Medical Information departments, including giving you feedback on best practice in Medical Information.  We’ve done UK, European and Global MI audits so why not give me a call to discuss your needs?