Medical Affairs Focus

Thoughts on Global Medical Affairs

Category Archives: Quick Note

QuickNote: Sunshine Act – Are Mechanics Crowding Out Relationship Management?

Readers of this blog know that I have strong opinions about MA’s role in the success of the Sunshine Act in their companies.  MA is responsible for long-term scientific engagement with the company’s top external experts, and these are the very people most likely to be negatively impacted by the Sunshine Act compliance if it is handled wrong.  Clinical is focused on the next study, commercial is focused on the next sale, only MA is focused on the overall relationship.

It is for that reason that I have been increasingly concerned when a number of my friends in the industry have told me how little, if at all, many MA organizations have been engaged in the efforts so far.  To be fair, many organizations are focusing on the mechanics right now – gathering the right data, centralizing data from a range of different sources, coding it in the right way and reporting it effectively – most if which is not the responsibility of MA.  Nevertheless, precious time is being wasted on the relationship side of this effort.

So, this is my call to action.  If by June 1, your organization has not begun an overall communications and relationship management plan spearheaded by MA, you are officially behind the curve.  The data will need to be collected as of August 1, and your MSLs should be explaining the why’s and what’s of this process before that data begins to be collected.  They can’t do that without a thorough communication plan.  And, some KOLs are likely to react in a less than positive way to this development – you need a plan to handle this as well.

The platform is burning – time to push ahead and take the lead in this effort!

Advertisements

Welcome to MA Focus Blog

Welcome!   I have been getting some new readers and I wanted to welcome you to the MA Focus blog.  My goal with the blog is to discuss issues that are relevant to MA leaders.  I encourage you to add your email to the distribution list (use the “Follow this blog”  link on the right) so you will be notified when there is a new post.  Promise, no spam!

Please take the time to look over some of our archives.  We have discussed a range of topics including MSL proactivityKOL identification, MedComm/SciComm groupsMA at Product LaunchGlobal MA and MA’s Relationship with Commercial, just to name a few.

Finally, I really enjoy feedback so please feel free to leave comments or email directly with questions (link on right).

Thanks for your interest.

Caronia Legal Discussion

For those of you who can’t get enough discussion about the Caronia case and its impact on off label promotion, Law Journal TV has done a panel discussion about it.  Worth a watch but mostly confirms what we have been discussing here.

Off to DIA MSC in AZ

I’m heading out on Monday to the DIA Medical and Scientific Communications 2013 Annual Forum in AZ.  Looks like there will be over 500 people attending which is a great crowd.  I will be presenting on Wednesday at 1:30 as a part of the Hot Topics in Operational Leadership session in the MSL track.  Please come by if you are at the conference.

I will write up summaries of some of the presentations for those of you who cannot attend the meeting.

 

New To The MA Focus Blog?

Welcome!  My stats say that I have been getting a bunch of new readers and I wanted to welcome you to the MA Focus blog.  My goal with the blog is to discuss issues that are relevant to MA leaders.  I encourage you to add your email to the distribution list (follow this blog link on the right) so you will be notified when there is a new post.  Promise, no spam!

Please take the time to look over some of our archives.  We have discussed a range of topics including MSL proactivity, KOL identification, MedComm/SciComm groups, MA at Product Launch, Global MA and MA’s Relationship with Commercial, just to name a few.

Finally, I really enjoy feedback so please feel free to leave comments or email directly with questions (link on right).

Thanks for your interest.

QuickNote: Off Label Promotion Ruled OK by US District Court

In a ruling with huge potential impact on MA as well as commercial functions, the Court of Appeals for the Second Circuit in Manhattan has overturned a conviction of a salesperson who was promoting the off-label use of a product! This 2-1 ruling goes against years of court rulings stating that pharma does not have the right to promote off-label.  In fact,  in the past month GSK has been fined $3 billion for off-label promotion and J&J fined $181 million for off label promotion.

Clearly, new legal ground is being broken here.  BUT, if urge caution.  This is one ruling that contradicts years of previous rulings.  It may serve as grounds for kicking this up to the Supreme Court, but until clear legal direction is given I would not be changing any policies.

Take a look at the article here and the actual ruling here.

QuickNote: The Sunshine Act is Here to Stay!

Given the results of the presidential election, the remaining hopes I have heard expressed that the Sunshine Act would not be implemented should have evaporated.

We have already discussed here some immediate work MA needs to do to start prepping the ground for the data.  While it is looking likely that implementation may be delayed, MA leaders should be planning for this in their 2013 budgets.

Any other impacts of the election that MA leaders should consider?  Leave your thoughts in the comments.