Medical Affairs Focus

Thoughts on Global Medical Affairs

Monthly Archives: August 2015

Topic 41: The Implications of Amarin. Is It “Good” for MA?

A number of my friends in MA leadership have been debating the implications of the Amarin case for MA overall. Spoiler alert – I think it will prove to be another avenue for MA to add value and I will share my rationale below.

In case you have not been reading up on this case, you can see my brief discussion and some links to other sources of information on this blog post. When discussing the Amarin case it is critical to understand the context – this case was decided by a federal district judge in Manhattan for the Southern District of New York – so obviously this ruling does not set national standards. However, the Southern District court is one of the most influential and active courts in the US and it has a history of leading the nation.

Assuming that this ruling becomes the precedent for either other cases in other districts or even national cases, the question is if/when pharmaceutical companies have the flexibility to promote off-label data (with all the fair/balanced caveats) – what are the implications for MA?

So let’s go on a trip to a speculative future in which the ability to share off-label data with HCPs on proactive basis becomes accepted in the US. In this future, I would fully expect that the FDA decides to put guardrails around this freedom. Their rationale will be simple – there is high risk to patients if HCPs make decisions based on off-label information which have not run the full risk/benefit analysis of a product with an approved NDA. What would these regulations look like? We can get a good view from FDA’s response to Amarin (which we covered in detail here) the summary of which is that this education would need to be fair and balanced and, among many other things:

  • Discussions should be conducted by persons with the appropriate background or training to accurately communicate scientific information

That would clearly call for a role similar to the MSL or field force role of today’s MA. But would that role need to be in MA, or more provocatively, would MA need to be a separate entity from commercial.

Those you that have been around the industry long enough remember when MA was sometimes a function of commercial, often called Scientific Sales. Driven by increasing FDA and EMA scrutiny primarily concerning off-label promotion and a desire to be seen as a voice of science instead of promotion, MA as an independent, non-promoting entity became the standard.

In our speculative future the US has loosened the off-label promotion rules, but the EMA has not and the need for an independent voice for science has not decreased so I do not foresee an effort to move MA back under commercial. Frankly that ship has already sailed since so many other functions that MA serves also benefit from it being independent from commercial.

So if MA is likely to remain independent would the MSL role remain in MA? I think that they would, not only due to inertia (although you can never over-estimate the power of inertia in pharma) but also because keeping the MSL role in MA would improve the case that the information presented was fair/balanced and not tainted by promotional messages.

Following my logic stream, MSLs would gain a new capability (ability to pro-actively share off-label data) while remaining in an MA function independent from commercial – so a net improvement to the value that MSLs and MA overall brings to the company. That can only be a good thing for MA leaders.

That was quite a bit of speculation – what is your opinion? Please click here to leave a comment.

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Topic 40: BREAKING: Court Rules FDA Cannot Prevent Truthful Off-label Promotion

In a court case that may have huge implications for pharma, a federal district judge in Manhattan ruled that the FDA cannot prevent a company from conducting off-label promotion if the promotion is truthful and scientifically accurate.

This ruling stems from the Amarin case that we discussed HERE.  In that case, Amarin argued that the precedent set by the Caronia case (which we discussed HERE) allowed them to promote off-label if the information shared was truthful and not misleading.  The FDA argued that the Caronia ruling was specific to those circumstances only and did not apply to Amarin.  Judge Engelmayer wrote in today’s ruling that “…A fair reading of that decision refutes the F.D.A.’s view that the Second Circuit’s ruling was limited to the facts of Caronia’s particular case.”

While this only currently applies to the circuit in question, it is a clear precedent that will need to be addressed if the FDA intends to retain its current regulatory approach to off-label promotion.  The FDA has not stated whether it intends to appeal but it did not appeal the Caronia ruling, a decision some pundits felt was made to avoid having a broader precedent set for allowing truthful off-label promotion.

This is an ongoing story but it could have some major implications for pharma and medical affairs.  Stay tuned to this space for more developments as they occur.

Any comments or thoughts on today’s news?  Click here to share them.