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!!
Focus on MA Ops Issues
Friday, January 25, 2013
Thursday, January 24, 2013
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.
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.
Monday, January 7, 2013
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:
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?
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?
Thursday, December 20, 2012
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.
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.
Rant: Treatment Guidelines and Biopharma
Have you seen the recent analysis by the Milwaukee Journal Sentinel about biopharma’s influence on treatment guidelines? If not, you should take a look at it here.
In summary, it reveals the startling fact that physicians who are on treatment writing committees are also often consultants to Biopharma and states that because of this there is a conflict of interest for the physicians. I find these arguments incredibly frustrating and I think we as a community must push back against them strongly.
On the surface, the conflict of interest argument makes sense but when you scratch the surface a bit it falls apart. By definition, treatment guidelines not only serve to support patient treatment but they are also used to define standard of care for reimbursement purposes - reimbursement not just for drugs but for all the aspects of treatment. In general a practicing physician, even one that gets some income from Biopharma consulting, earns most of their income by being reimbursed for treatment they perform. Some physicians have major financial stakes in treatment reimbursement but no one is (or should) suggesting that a doctor would push for an unnecessary or less effective treatment option just because it would likely be more lucrative to the doctor. No one is claiming that the largest sources of most of these physicians’ incomes drive a conflict of interest.
But, when it comes to drug treatment, the newspaper story argues that this same ethic goes right out the window and the physicians become pawns to the big bad Biopharma companies. This is ridiculous. Physicians who consult to Biopharma generally do so because they are subject matter experts and want the drugs that are developed to most effectively treat their patients. To imply that by providing that support to Biopharma they suddenly lose their ability to correctly judge what should or should not be in a treatment guideline is insulting to the professionalism of physicians.
As someone who has dedicated a big chunk of my career to helping Biopharma work better with physicians, I know that those physicians are professionals and will do what is best, not lackeys that will do as they are told.
What do you think? Please leave a comment.
In summary, it reveals the startling fact that physicians who are on treatment writing committees are also often consultants to Biopharma and states that because of this there is a conflict of interest for the physicians. I find these arguments incredibly frustrating and I think we as a community must push back against them strongly.
On the surface, the conflict of interest argument makes sense but when you scratch the surface a bit it falls apart. By definition, treatment guidelines not only serve to support patient treatment but they are also used to define standard of care for reimbursement purposes - reimbursement not just for drugs but for all the aspects of treatment. In general a practicing physician, even one that gets some income from Biopharma consulting, earns most of their income by being reimbursed for treatment they perform. Some physicians have major financial stakes in treatment reimbursement but no one is (or should) suggesting that a doctor would push for an unnecessary or less effective treatment option just because it would likely be more lucrative to the doctor. No one is claiming that the largest sources of most of these physicians’ incomes drive a conflict of interest.
But, when it comes to drug treatment, the newspaper story argues that this same ethic goes right out the window and the physicians become pawns to the big bad Biopharma companies. This is ridiculous. Physicians who consult to Biopharma generally do so because they are subject matter experts and want the drugs that are developed to most effectively treat their patients. To imply that by providing that support to Biopharma they suddenly lose their ability to correctly judge what should or should not be in a treatment guideline is insulting to the professionalism of physicians.
As someone who has dedicated a big chunk of my career to helping Biopharma work better with physicians, I know that those physicians are professionals and will do what is best, not lackeys that will do as they are told.
What do you think? Please leave a comment.
Wednesday, December 12, 2012
Topic19: MA Impact of the Caronia Ruling
As most of you know, the Caronia Ruling by the Second Circuit Court of Appeals found that a pharma rep was within his 1st Amendment rights to discuss off label use of his company’s drugs, assuming that those discussions were truthful. This went off like a rifle shot within the pharma world with all sorts of discussions, you can read some of them here, here and here.
It is very likely that this ruling will be appealed to the full Second Circuit, and/or directly to the Supreme Court. But there are reasons to believe that the Supremes may be open this interpretation given their past rulings on similar subjects. Regardless, until this is settled it only applies to the Second Circuit so unless you are a pharma company only doing business in the Second Circuit in and around New York, you can’t make much change.
BUT, what if this becomes the new law of the land? What does it mean for Medical Affairs? That’s what I want to explore in this blog post.
The most obvious impact it has is on all the current focus we place on “proactivity”. I have discussed this topic in detail here, here, and here. I bemoaned the unclear state of the current regs here. Now we are imagining a world where the issue of proactivity has to be seen in a completely different light. MA avoided proactively discussing off-label data on our products because proactivity implied promotion and it is (or in our scenario was) illegal to promote off label. Under this scenario that thinking would be wrong. Replaced, potentially, with a focus on “truthfulness”.
Now, for MA at least, this is an expectation we are more than willing to meet. In the past MA has typically thought of any peer reviewed study as truthful but some of the commentators are suggesting that the definition might become the same one that they use for the FTC. The FTC definition id focused on “…competent, reliable scientific evidence supporting the claims you are making…” so it may not require a peer reviewed journal publication. The one caveat, however, is that if you conduct a test and find that the content being shared is misleading to 20% or more of the targeted consumers, than it is not considered truthful. In general, then, although peer reviewed journals would not be a requirement, it would represent a fairly safe harbor to avoid the risk of sounding misleading.
So, in the future world we are imagining, our field force of MSLs would be free to go out to HCPs armed with peer reviewed journal articles, and introduce the HCP to that article and then proceed to have a scientific exchange about the results, assuming they stick to findings documented in that or other peer reviewed articles.
Scientifically speaking, this frees MSLs to have very wide ranging discussions with HCPs at their initiation and allows for much greater control over the type of discussions that we have with the HCPs. It will allow MSLs to show much greater value to the organization by allowing the targeting of discussions that are the most meaningful to our products. And if you think is hard to hire MSLs today, watch out. With that increase in value will come greater investment in both MSLs and in Investigator Initiated Studies and P4 studies that will now be seen as more valuable as well.
What do you think? Do you think it we will see the end of proactivity restrictions in the next three years? Leave your comments above.
It is very likely that this ruling will be appealed to the full Second Circuit, and/or directly to the Supreme Court. But there are reasons to believe that the Supremes may be open this interpretation given their past rulings on similar subjects. Regardless, until this is settled it only applies to the Second Circuit so unless you are a pharma company only doing business in the Second Circuit in and around New York, you can’t make much change.
BUT, what if this becomes the new law of the land? What does it mean for Medical Affairs? That’s what I want to explore in this blog post.
The most obvious impact it has is on all the current focus we place on “proactivity”. I have discussed this topic in detail here, here, and here. I bemoaned the unclear state of the current regs here. Now we are imagining a world where the issue of proactivity has to be seen in a completely different light. MA avoided proactively discussing off-label data on our products because proactivity implied promotion and it is (or in our scenario was) illegal to promote off label. Under this scenario that thinking would be wrong. Replaced, potentially, with a focus on “truthfulness”.
Now, for MA at least, this is an expectation we are more than willing to meet. In the past MA has typically thought of any peer reviewed study as truthful but some of the commentators are suggesting that the definition might become the same one that they use for the FTC. The FTC definition id focused on “…competent, reliable scientific evidence supporting the claims you are making…” so it may not require a peer reviewed journal publication. The one caveat, however, is that if you conduct a test and find that the content being shared is misleading to 20% or more of the targeted consumers, than it is not considered truthful. In general, then, although peer reviewed journals would not be a requirement, it would represent a fairly safe harbor to avoid the risk of sounding misleading.
So, in the future world we are imagining, our field force of MSLs would be free to go out to HCPs armed with peer reviewed journal articles, and introduce the HCP to that article and then proceed to have a scientific exchange about the results, assuming they stick to findings documented in that or other peer reviewed articles.
Scientifically speaking, this frees MSLs to have very wide ranging discussions with HCPs at their initiation and allows for much greater control over the type of discussions that we have with the HCPs. It will allow MSLs to show much greater value to the organization by allowing the targeting of discussions that are the most meaningful to our products. And if you think is hard to hire MSLs today, watch out. With that increase in value will come greater investment in both MSLs and in Investigator Initiated Studies and P4 studies that will now be seen as more valuable as well.
What do you think? Do you think it we will see the end of proactivity restrictions in the next three years? Leave your comments above.
Tuesday, December 4, 2012
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.
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.
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