Medical Affairs Focus

Thoughts on Global Medical Affairs

Monthly Archives: January 2013

Update: Off Label Free Speech Ruling Left Unchallenged at Appeals Level

As I discussed here, a recent ruling by the Second Circuit Appeals Court provided a new legal foundation for off-label promotion on free-speech grounds.  As the law currently stands in the Second Circuit, as long as the speech is “truthful” it is protected by the First Amendment and thus open to anyone.  Sales reps and MSLs in Ney York, Conn. and Vermont have one less thing to worry about.

Many, myself included, assumed that the FDA would ask for a re-hearing in the Second Circuit, but that date has come and gone without such a request.  You can read about it here.

At this point the FDA can go two ways – they can ignore the ruling and let it stand for the Second Circuit, which may result in a set of haphazard interpretations over time as different Circuit Counts rule differently, or it can appeal the ruling the Supreme Count.  Assuming the Supreme Court would agree to hear the case, appealing it to them could result in a ruling that the Second Circuit ruling should be the law of the land.

So the FDA is left with a choice – take what it has and accept that the off-label promotion rules may gradually crumble or risk those rules completely by appealing to the Supremes.  They have until mid-March (or until mid-May if they wish to extend their timeline) to make that decision.  I will continue to fill you in when I learn more – watch this space!!

Topic 21: ISS and the Web

I was speaking with a long time friend about this subject the other day and thought it would be an interesting blog post.

Investigator Initiated Studies (IIS) supported by biopharma grants is a significant element of MA responsibilities for some companies.  We will not be jumping into the strategic and scientific value of IIS studies with this post.  Instead, I will focus on the operational aspects, and specifically how I would think technology would make the process much more efficient.

Grant Application Process

Technology to manage the grant application process is widely available.  Transparency in this process is critical.  One of the goals of MA is to build positive working relationships with the scientific community and it is that same community of physicians and scientists applying for grants. So it is critical to ensure that the grant application process is just another element of the overall positive relationship.  That’s not to say all grant requests are supported, but the requesting process needs to be clear and efficient.  A good example of this can be seen at Celegene’s grant application webiste which includes an online application process and portal to allow the grant requestor visibility into the grant making process.

Not everyone can afford to build their own portal, but there are plenty of other solutions available over the web that require little in the way of investment and can meet the basic requirements, including here, here and here.

Depending on your interpretation of regulations, you may or may not be able to use these same systems to convey to the grant applicants that the organization’s research priorities are and grant resources are, to ensure that they have reasonable expectations.  See this example on the Genzyme page where they offer a direct link from the grant page to their research focus pages.

Study Execution Process

The use of the technology after the grant has been made varies widely among companies.  In the past, many organizations made the grant decisions, provided the product or funding, and then left the investigator alone.  After a period of time results either would or would not come out but the company had little involvement.  The problem with this approach is the situation where the IIS produced no results.  Without results, it calls into question the ethics of the funding.

So today, most organizations stay engaged in the IIS process but how they stay engaged varies widely.  I would like to suggest that one efficient way to stay engaged is to offer as part of the grant support the use of an electronic data capture (EDC) system.  While small scale studies like IIS don’t have to use systems like EDC since the data is limited, by providing such a service to the IIS it ensure that the study is capturing data in a structure manner, that the data is being managed and that the study will have something to show for the grant.  All these systems work over the web so there is no need for the IIS to manage the software themselves.

What has been your experience using technology to support IIS?  Leave a comment.

Topic20: MSL Organization Structure and Staffing Overview

I have had a number of posts about MSLs, including posts about MSLs driving value, posts about MSL team leadership and posts about MSLs vs. sales.  However, I have not discussed MSL organization structure and staffing.

When thinking about MSL organization, it’s important to start with MSL to management ratios.  Typically, the type of manager to staff ratios that work best in an MSL group is about 8 MSLs to 1 manager.  There are all sorts of reasons why this could be scaled up to 12 to 1, including a fairly static therapeutic areas, MSLs that work extensively with other functions like Clinical or Managed Markets, or a team of all veteran MSLs that need little coaching.  And there are all sorts of reasons you might want to scale back to 6 to 1 or even 5 to 1, if it’s a new therapeutic area for the company or inexperienced MSLs or a challenging KOL environment.  But, those extremes 5 to 1 on one end and 12 to 1 on the other are the practical end limits.  Much more than 12 people and it is not feasible for the manager to have a clear understanding of what their team is doing.  Less than 5 to 1 and there is not enough work to occupy a full time manager and you know I feel that is important (see post here).

Given those ratios, how should the teams be formed?  MSLs are inherently regional and that would lend themselves into regional organization structures, but they are also specialists often focused on a single therapeutic area or set of therapeutic areas.  If the MSL group is large enough, you can do both – separate MSL groups by therapeutic area then by region within those groups.  In reality, however, few organizations are large enough to organize that way.  As a result, most groups mix or combine therapeutic responsibilities and build regional teams.  To the degree that MSLs need therapeutic coaching, it can be provided through cross-team therapeutically aligned training and development.

Determining how many MSLs are needed starts with a clear definition of MSL responsibilities.  MSLs have such a potentially broad remit in today’s environment (they could theoretically be focused on activities in support of Clinical or Market Access activities as well as MA and scientific outreach) that without a clear definition scaling can’t be done.  Sometimes it’s a purely practical matter to determine this question – who is paying for the MSLs?  That often clarifies what types of activities they will perform.  But in many organizations MSLs routinely do work in support of functions other than the budget owner and so it really needs to be well defined.

Once the remit of the MSLs is understood, the next questions that help determine staffing are environmental.  Key factors include:

  • New or existing therapeutic area for the company
  • Complexity of the therapeutic area
  • Degree of competition for access to scientific experts
  • Expected changes in the therapeutic area in the next three years

Once the role of the MSL is understood and the environmental factors are clear, a good estimate of the work load can be developed and from there an estimated staffing level.

On another post I will discuss the challenge of starting up an MSL group from scratch and the buy or build decision.

What has been your experience in this area?  What ratios do you follow?