Given the ambiguity of the regulations, most organizations are reducing the degree of proactivity to ensure that they remain within compliance. Going to the left on the MA Spectrum of Proactivity. However, decreasing the degree of proactivity carries risks of its own.
Failing to Meet Obligations as Partners in Science
The most pressing risk associated with limiting the proactivity of MA outreach is that information that would have been useful to the HCPs does not get into their hands. While HCPs have the obligation to maintain their own knowledge, the reality is that there is so much information available that many HCPs cannot possibly keep up with everything, especially physicians that treat a range of disease states. They rely on many expert groups, including associations, practice standard setting bodies, journals and, yes, pharmaceutical companies to help point out information they may not have found on their own. Pharma companies often employ some of the leading experts on the disease state where they focus their research and have a positive perspective to share with the community.
Confusion Among HCPs
Given that many HCPs have traditionally relied on pharma as one of their sources for alerting them to new scientific information, the sudden halting of this support would normally be disruptive. But, even more challenging is the fact that this change will be unclear to the HCPs as different pharma companies set different policies. A pharma company that recently reduced its degree of proactivity surveyed some HCPs it would have normally interacted, and found a strong sense of betrayal by those HCPs that the organization had discontinued this support and an equally strong sense of confusion about why this support would be discontinued. Most HCPs surveyed said they would not replace proactive interaction with direct contact to the pharma companies because, to paraphrase one response, they don’t know what they don’t know to ask about.
Closing Thoughts
Every company needs to weigh risk and benefits with any decision it makes. Unfortunately, when it comes to proactivity many organizations have lately been focused entirely on risk. Even with the ambiguity noted in a previous post there appears to be room for some form of proactivity. And, HCPs are expecting it. For MA to achieve their goals, they need to work with their organizations to ensure that the benefit/risk is being considered in full before any changes are made.
What do you think? Leave a comment below.
Legal Note: All information and interpretations presented are only the opinion of the author(s) who are not lawyers. And, even if we were lawyers, given the wide range of interpretations of the current regulations you would still need to get the input from your own compliance organization. Simply put – your mileage may vary.
Focus on MA Ops Issues
Monday, May 28, 2012
Topic1: Proactivity vs. Risk- Subject to Interpretations
How can so many sophisticated organizations with access to piles of lawyers have such different interpretations? The answer is that the regulations themselves are less than clear in terms of pharma’s rights and limitations in terms of scientific outreach and education.
Here is a great reference page with most of the important regulations from the FDA web site:
Looking at things in terms of the MA Proactivity Spectrum discussed in the previous post, we see the following:
Disease State Proactivity
There is not approved guidance in this area yet, but here we have available a draft guideance:
Per the draft guidance, disease state education aimed at HCPs that does not mention and not make any suggestion concerning a particular drug is not considered advertising and thus not subject to advertising restrictions. There are many details behind this but this is a good starting point. Even here, with a direct guidance (draft), there are still areas of uncertainty as the Agency can take a different perspective based on the number of drugs or treatment options available.
Supportive Information for Existing Label
In this case, the most directly related regulations are those associated with the original FD&C and related comments since this is essentially discussions of an approved drug:
And,
Unapproved Use
In 21 CFR 312.7(a) we can see that FDA regulation restricting promotion of investigational new drugs provides that a manufacturer may “disseminat[e] . . . scientific findings in scientific or lay media” without engaging in promotional activity, but promotional claims of safety or effectiveness for a use for which the product is under investigation are subject to FDA regulation as advertising or labeling.
Hence the draft guidance available:
Closing Thought
Clearly there is a lot to consider but the most important takeaway is the understanding that these regulations are subject to interpretations when you consider MA’s role in pharma, thus the need for an effective compliance department and the “room” for the MA Proactivity Spectrum.
What do you think? Leave a comment below.
Legal Note: All information and interpretations presented are only the opinion of the author(s) who are not lawyers. And, even if we were lawyers, given the wide range of interpretations of the current regulations you would still need to get the input from your own compliance organization. Simply put – your mileage may vary.
Here is a great reference page with most of the important regulations from the FDA web site:
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm109905.htm
Looking at things in terms of the MA Proactivity Spectrum discussed in the previous post, we see the following:
Disease State Proactivity
There is not approved guidance in this area yet, but here we have available a draft guideance:
"Help-Seeking" and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms*DRAFT*(Issued 1/26/2004, Posted 2/4/2004)
Per the draft guidance, disease state education aimed at HCPs that does not mention and not make any suggestion concerning a particular drug is not considered advertising and thus not subject to advertising restrictions. There are many details behind this but this is a good starting point. Even here, with a direct guidance (draft), there are still areas of uncertainty as the Agency can take a different perspective based on the number of drugs or treatment options available.
Supportive Information for Existing Label
In this case, the most directly related regulations are those associated with the original FD&C and related comments since this is essentially discussions of an approved drug:
Federal Food, Drug and Cosmetic Act
Chapter II - Definitions (Sec. 201 [321] (g)(1), (k), (m), (n), & (p))
Chapter III - Prohibited Acts and Penalties (Secs. 301 [331], 302 [332], 303 [333], & 304 [334])
Chapter V - Drugs and Devices (Sec. 502. [352] (a), (e), (f), & (n))
And,
Code of Federal Regulations
The following links go to the Government Printing Office web site.
21 CFR 99 - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
Unapproved Use
In 21 CFR 312.7(a) we can see that FDA regulation restricting promotion of investigational new drugs provides that a manufacturer may “disseminat[e] . . . scientific findings in scientific or lay media” without engaging in promotional activity, but promotional claims of safety or effectiveness for a use for which the product is under investigation are subject to FDA regulation as advertising or labeling.
Hence the draft guidance available:
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices*DRAFT* (Posted 12/27/2011)
Closing Thought
Clearly there is a lot to consider but the most important takeaway is the understanding that these regulations are subject to interpretations when you consider MA’s role in pharma, thus the need for an effective compliance department and the “room” for the MA Proactivity Spectrum.
What do you think? Leave a comment below.
Legal Note: All information and interpretations presented are only the opinion of the author(s) who are not lawyers. And, even if we were lawyers, given the wide range of interpretations of the current regulations you would still need to get the input from your own compliance organization. Simply put – your mileage may vary.
Topic1: Proactivity vs. Risk- The Spectrum of Proactivity
Note: This analysis is entirely based on the US regulatory regime.
The reason proactivity is such an interesting topic is the wide range of standards found in the industry today. Similarly sized organizations often have very different interpretations of what is and is not acceptable in terms of proactive outreach with health care providers (HCPs). As a result, it’s easiest to think of the degrees of proactivity as a spectrum. The spectrum looks something like this:
Many organizations have interpreted the regulations in different ways given different situations, so as a practical matter organizations tend to jump around a bit on the spectrum. And this excludes a range of proactive discussion topics that are potentially acceptable but highly guided, examples include:
No Proactivity
Believe it or not, there is at least one major pharma company that currently employs this standard. It calls into account the value of the MA field organization unless it is primarily focused on the exclusions above. It also makes it critical to have a strong link between the phone- and internet- based information request systems and the MA field organization to make sure that they are responding effectively.
Disease State Proactivity
This is the degree of proactivity that most “conservative” interpretations of the regulations tend to find acceptable. Many organizations limit their MA field organizations to this degree of proactivity.
The focus of this outreach is to educate HCPs on the current science behind a disease state without focusing on any particular treatment option. This can be tremendously valuable to a pharma company as many practicing HCPs find it highly challenging to keep up with all the latest science and may not realize the strengths and challenges with the given treatment options.
Supportive of Label Proactivity
Our commercial colleagues proactivity discuss exactly what is on the label with HCPs. Many organizations will allow their MA field organization to share additional information supportive of the label but it is less common than those that restrict proactivity to the disease state.
In this interpretation of the regulations, MA organizations share additional, supportive information that is not found directly within the label, such as additional studies included in the NDA filing or subsequent studies that are supportive of the label. It is critical that the science remains within the “confines” of label and merely extends the information supporting that document.
Off-label Proactivity
Clearly this is an unacceptable risk for almost all organizations given the likelihood that it can be interpreted as off-label promotion.
Closing Thoughts
While I don’t think anyone can argue that avoiding proactive discussions about off-label use has been a positive development in terms of risk reduction, the further eroding of the range of acceptable proactivity is definitely more of a mixed bag. While risk may be reduced, the ability to serve the medical community by educating them on critical information has also been reduced.
And, from an entirely practical point of view, this range of proactivity is confusing as heck for the HCPs we aim to support. They don’t know that different organizations have different compliance interpretations and risk tolerances – all they know is that some MA staff are more helpful than others.
And, at least we have a range – this is the range of our commercial colleagues:
I would be interested to hear your thoughts – please leave a comment.
Legal Note: All information and interpretations presented are only the opinion of the author(s) who are not lawyers. And, even if we were lawyers, given the wide range of interpretations of the current regulations you would still need to get the input from your own compliance organization. Simply put – your mileage may vary.
The reason proactivity is such an interesting topic is the wide range of standards found in the industry today. Similarly sized organizations often have very different interpretations of what is and is not acceptable in terms of proactive outreach with health care providers (HCPs). As a result, it’s easiest to think of the degrees of proactivity as a spectrum. The spectrum looks something like this:
Many organizations have interpreted the regulations in different ways given different situations, so as a practical matter organizations tend to jump around a bit on the spectrum. And this excludes a range of proactive discussion topics that are potentially acceptable but highly guided, examples include:
- In support of company-sponsored clinical trials
- In support of acquiring the services of an HCP as a consultant (for example to serve on an Advisory Board)
- The providing of reprints following Good Reprint Practice
No Proactivity
Believe it or not, there is at least one major pharma company that currently employs this standard. It calls into account the value of the MA field organization unless it is primarily focused on the exclusions above. It also makes it critical to have a strong link between the phone- and internet- based information request systems and the MA field organization to make sure that they are responding effectively.
Disease State Proactivity
This is the degree of proactivity that most “conservative” interpretations of the regulations tend to find acceptable. Many organizations limit their MA field organizations to this degree of proactivity.
The focus of this outreach is to educate HCPs on the current science behind a disease state without focusing on any particular treatment option. This can be tremendously valuable to a pharma company as many practicing HCPs find it highly challenging to keep up with all the latest science and may not realize the strengths and challenges with the given treatment options.
Supportive of Label Proactivity
Our commercial colleagues proactivity discuss exactly what is on the label with HCPs. Many organizations will allow their MA field organization to share additional information supportive of the label but it is less common than those that restrict proactivity to the disease state.
In this interpretation of the regulations, MA organizations share additional, supportive information that is not found directly within the label, such as additional studies included in the NDA filing or subsequent studies that are supportive of the label. It is critical that the science remains within the “confines” of label and merely extends the information supporting that document.
Off-label Proactivity
Clearly this is an unacceptable risk for almost all organizations given the likelihood that it can be interpreted as off-label promotion.
Closing Thoughts
While I don’t think anyone can argue that avoiding proactive discussions about off-label use has been a positive development in terms of risk reduction, the further eroding of the range of acceptable proactivity is definitely more of a mixed bag. While risk may be reduced, the ability to serve the medical community by educating them on critical information has also been reduced.
And, from an entirely practical point of view, this range of proactivity is confusing as heck for the HCPs we aim to support. They don’t know that different organizations have different compliance interpretations and risk tolerances – all they know is that some MA staff are more helpful than others.
And, at least we have a range – this is the range of our commercial colleagues:
I would be interested to hear your thoughts – please leave a comment.
Legal Note: All information and interpretations presented are only the opinion of the author(s) who are not lawyers. And, even if we were lawyers, given the wide range of interpretations of the current regulations you would still need to get the input from your own compliance organization. Simply put – your mileage may vary.
Topic1: Introduction- Proactivity vs. Risk in HCP Interactions
Each week or so on Medical Affairs Focus we identify a topic of interest to MA leaders and share a series of short posts on the topic.
This week’s topic is Proactivity versus Risk in HCP Interactions. For the purpose of this discussion, we will use the US regulatory regime. This is a topic that has increasingly been important to my clients as they attempt to chart a course for their field outreach teams. The degree of acceptable proactivity is directly tied to the value that the field team brings to the organization (which will be a topic for another week). As organizations grow more risk averse, they are increasingly ratcheting back the proactivity of their field outreach. We’ll discuss the following:
As always, please add your experience and questions in the comments.
Legal Note: All information and interpretations presented are only the opinion of the author(s) who are not lawyers. And, even if we were lawyers, given the wide range of interpretations of the current regulations you would still need to get the input from your own compliance organization. Simply put – your mileage may vary.
This week’s topic is Proactivity versus Risk in HCP Interactions. For the purpose of this discussion, we will use the US regulatory regime. This is a topic that has increasingly been important to my clients as they attempt to chart a course for their field outreach teams. The degree of acceptable proactivity is directly tied to the value that the field team brings to the organization (which will be a topic for another week). As organizations grow more risk averse, they are increasingly ratcheting back the proactivity of their field outreach. We’ll discuss the following:
As always, please add your experience and questions in the comments.
Legal Note: All information and interpretations presented are only the opinion of the author(s) who are not lawyers. And, even if we were lawyers, given the wide range of interpretations of the current regulations you would still need to get the input from your own compliance organization. Simply put – your mileage may vary.
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