INDUSTRY SOLUTION
Common Compliance Challenges with
Speaker Programs
Learning from Our Monitoring Experience
B
ased on our monitoring experience, up to 5% of programs have some
kind of observable compliance issue. That may not sound like much,
but it becomes significant when multiplied over the several hundred or
more programs you sponsor every year. Make sure you have identified
your most important risk issues upfront and included questions about
them in your monitoring template. If you take the time to think through
different risk scenarios beforehand, it is more likely that you will have a
successful communication and training strategy for your speakers and
representatives that will minimize compliance risk.
If you take the time to
think through different risk
scenarios beforehand, it is
more likely that you will have a
successful communication and
training strategy...
Some of the most common speaker program compliance challenges that
we have observed are discussed below:
1. Speakers and Representatives answer
off-label questions incorrectly.
W
hen training your speakers and/or sales representatives, you should
communicate clear expectations on the proper way to address
off-label questions or statements from attendees during educational
programs. Keep in mind that many speakers also do presentations for
other companies and may have difficulty keeping every company’s offlabel engagement policies straight in their mind. In the case of your
representatives, as the company host of the program, they may not feel
comfortable interrupting a presentation to correct speaker responses,
either for fear of offending the speaker, or perhaps because they don’t have
the same depth of clinical/medical background as the speaker leading
the discussion. In either case, it is important to help representatives
understand that their role is to ensure the program stays within the
bounds of compliance. They should make sure the company’s labeling is
reinforced, whether by the speaker or by their own actions, or by both
if needed. Some of the off-label handling issues your company should
address with policies, procedures and training include:
♦♦ Should responses be different to an off-label question versus an off-label
statement? A question usually involves an attendee seeking information not
found in your label. A statement is an assertion by an attendee that he or she
is using your product in a way that is not consistent with your label. Whatever
the case, the speaker and/or the representative have an obligation to point out
what the approved labeling is for the product under discussion. However, if
2
Common Compliance Challenges with Speaker Programs
©©Copyright 2015, Searchlight Compliance Advisors
it is a question, you need to decide how and under what circumstances the
speaker can respond (see the next set of questions for more information).
In the case of an off-label statement, it is probably sufficient to reinforce the
correct label information with the attendee, and then transition back to the
presentation.
♦♦ If an off-label question is asked, should it be addressed at that moment
or deferred until after the conclusion of the program? Should a speaker
respond to an off-label question in front of the entire group or only in a
one-on-one setting with the person asking the question? Your company
should decide how your speakers or representatives handle the risk of
addressing off-label issues. Some companies do not allow the speaker or the
representative to answer any off-label questions, and when they come up
in a presentation they require them to state that the request is off-label and
will not be addressed. Other companies prefer to handle the situation by
having speakers and/or representatives refer the question to their Medical
Affairs department to be answered via a medical information request. Some
companies may give the speaker the ability to answer the question, but only in
a one-on-one setting at the conclusion of the program rather than in front of
the entire group. You should evaluate the risk profile of the product and the
potential for off-label questions and determine what response scenario you
feel will best limit risk exposure.
♦♦ What should the representative do if the speaker responds to questions
inadequately or makes incorrect statements? Representatives wear many
hats in their work: product promoter, customer point of contact, competitive
intelligence gatherer, etc. In the context of an educational program, they
are typically the originator of the invitations prior to the event, they followup with invitees to confirm attendance, and they handle all related on-site
logistics and follow-up. As the host of the program, they also have a duty to
ensure speakers adhere to company policies, and have an obligation to step
in if statements made or answers given by the speaker violate policy. While
sharing general guidance about enforcing program policies is useful for all
representatives, compliance personnel would be well served to examine each
product profile and associated program slide decks in advance and try to
anticipate beforehand what potential risks could arise during a program. This
may lead to additional guidance about particular circumstances where the
representative may need to be vigilant.
Common Compliance Challenges with Speaker Programs
Copyright 2015, Searchlight Compliance Advisors
3
♦♦ Under what circumstances should a medical information request be
created and submitted? Based on the approved label for the product and
competitive market conditions, Medical Affairs personnel will usually prepare
a variety of responses to product questions they anticipate will be asked
during the course of ongoing HCP interactions. Speaker programs often
provide a forum for attendees to ask questions to speakers about their clinical
experience with a product or how they have handled difficult to treat cases.
While it is usually advisable for these types of questions to be referred as
medical information requests, it has been repeatedly observed that program
attendees often decline to do so because they perceive these requests to be
“canned responses” that offer little useful information. As a result, speakers
sometimes respond to these types of questions on the spot based on their own
clinical experience, but in so doing they may not be offering an answer that
adequately reduces regulatory risk. Medical Affairs should look on programs
as a unique opportunity to gather commonly asked questions of interest to
the medical community after the product has been launched, and prepare
responses to their information requests that will offer valuable information to
customers while maintaining proper fair balance.
2. Speakers and Representatives make
off-label statements.
W
e have observed that off label statements by speakers or
representatives usually take the form of minimizing safety (e.g.,
“I know the label says that this product has XX side effect, but I’ve never
seen it in my practice”) or overselling efficacy (e.g., “this product is the
greatest thing since sliced bread”). Companies can minimize risk by
ensuring the program materials for speakers predominantly use pivotal
trial efficacy and safety data from the label. It is also important to include
important ISI information throughout the presentation as fair balance,
covering any black box warnings and precautions, special instructions
on use in specific populations (elderly, immunocompromised,
pregnancy, etc.), contraindications, drug–drug interactions, and dosing
and administration. In addition, role-playing during speaker and
representative training can help company participants model the best
and most appropriate way to present material and respond to attendees’
questions or comments.
4
Common Compliance Challenges with Speaker Programs
©©Copyright 2015, Searchlight Compliance Advisors
3. Attendees use the program to get
individual treatment consultation advice
from the speaker - which may include offlabel uses.
H
ealth care professionals value peer-to-peer interaction, especially if it
includes the ability to consult with other physicians experienced in
handling difficult to treat cases. We have frequently observed attendees
ask for advice or counsel from speakers on how to treat challenging
cases, including asking if they can use a product in an off-label fashion
to address a similar, but un-indicated condition. We have observed that
some clients dissuade speakers from offering any kind of personal clinical
advice, while others prefer that clinicians refer these types of questions to
Medical Affairs or Medical Science Liaison representatives. Still others
allow speakers to answer as long as the case can be handled with onlabel advice. We have also seen some speakers give their business card
to attendees and indicate they can speak to them outside of the program
if the attendee will contact them later. Companies should decide ahead
of time to what extent clinical peer to peer consultations or advice will
be admissible in the context of a speaker program, and then provide
guidance for speakers on how to handle these types of questions.
4. Representatives do not capture medical
information requests or adverse event
reports.
I
n some programs, discussions between speakers and attendees lead to
questions where there is not a clear answer, or to information being
shared about side effects experienced by specific patients that led to
changes in treatment. What are your policies about the capture of this
information, either in the form of a medical information request or an
adverse reaction report? It is worthwhile to have periodic refresher
trainings with speakers and representatives to discuss the circumstances
where a specific request or report should be submitted to the company.
Providing an incomplete answer to a program attendee, or forgoing the
reporting of a post-marketing side effect that is already in the product
label is not the answer – providing compliant answers and/or ensuring
complete post-marketing AE reporting is.
Common Compliance Challenges with Speaker Programs
©©Copyright 2015, Searchlight Compliance Advisors
5
5. Representatives do not correct
inaccurate statements by speakers.
A
In many programs that we
monitor, representatives do not
make the PI readily available.
s the program host, representatives are sometimes put in the position
of having to step in and correct speakers when they make incorrect
statements. Simple misstatements about the half-life of a medication,
or the misreading of numbers on a slide, can be easily corrected by
representatives in a friendly and cooperative fashion. However, there are
times when representatives need to have the courage to speak up if they
observe a program going off the rails. This can happen when speakers
engage with attendees in discussions that involve peer-to-peer clinical
advice, medical information requests, competitive comparisons, side
effects in specific patients or patient types or off-label inquiries. Making
representatives aware of the types of situations where they will need
to intervene, and doing some role-playing training with some specific,
scripted approaches that representatives can use, will go a long way
towards preparing them for times when they will need to step in to avoid
compliance risk.
6. Representatives do not make prescribing
information available to all attendees.
D
uring the course of a presentation, many of the questions
asked by attendees can often be answered by referring to the
product prescribing information. Yet in many programs we monitor,
representatives do not make the PI readily available. While it is likely
that representatives could produce a copy of the PI if asked, it is better
to clearly spell out the expectation of how or where it should be made
available to attendees. Some clients specify that it be provided at the
entrance to the dining room; others at the location where participants
sign in; others specify that it be placed on the dining table or at each place
setting. Wherever you decide it should be placed, compliance risk can
be reduced by providing attendees with prescribing information they can
refer to both during and after the presentation.
6
Common Compliance Challenges with Speaker Programs
©©Copyright 2015, Searchlight Compliance Advisors
7. Content presentation programs that
don’t work properly.
W
ith the emphasis on ensuring that speakers stick to the provided
slides and do not add any additional material not aligned with
the label, many companies are electing to provide speakers with content
presentation programs. These programs are designed to only allow the
speaker to show specific slides during the course of the presentation.
Usually these slide programs have been developed by third party
vendors using proprietary custom-built software. When they work well,
they ensure compliance by keeping speakers on track with the slides
they should be presenting. However, these programs can sometimes
malfunction – we have observed instances where they do not always
display the correct slide, or may in fact display the slide within the
computer layout view, but when they project onto a screen they will not
display some or all of the slide content. It is important that compliance
personnel work with their marketing colleagues to vet presentations in
multiple viewing modes to ensure that representatives or speakers are
not left with incomplete product presentations because of technological
glitches.
Common Compliance
Challenges Recap:
1. Off-label questions
answered incorrectly.
2. Off-label statements by
company representatives.
3. HCP’s use event to
get specific treatment
consultation.
4. Speakers make
8. Speakers and Representative interactions
with third party content providers or
program managers don’t resolve problems.
inaccurate statements and
M
requests or adverse events
any companies contract with third party vendors to manage
various aspects of speaker programs: content creation, content
presentation, venue site and menu selection, event scheduling, AV
support, speaker payments, etc. Sometimes these vendors have robust
processes to provide support or answer questions, and sometimes
they don’t. We have observed problems in the field with speakers and
representatives having support issues with content presentation software,
mix-ups in program scheduling, and differentiated payments for multiple
events during a single trip, etc. It is important to vet third party offerings
in advance of purchasing their services, and you should request references
from other customers. It is also important to include in your contract
expected service levels and remedies if third party service does not meet
expectations. On your end, it is also important that speaker program
policy documents clearly spell out the differences in payment for types of
programs (local vs. national programs, webinars, lunch programs, etc.)
are not corrected.
5. No medical information
reports are captured.
6. No PIs made available.
7. Presentation programs
don’t work.
8. Third party service
problems.
9. Issues with the venue.
Common Compliance Challenges with Speaker Programs
Copyright 2015, Searchlight Compliance Advisors
7
so program management vendors have no problems interpreting and
applying your policy whenever questions arise. It is also wise to have an
escalation procedure spelled out for representatives and speakers so if they
have problems with third party vendors, they have someone to speak with
internally that can help resolve the situation if third party vendors cannot.
9. Issues with the program venue (drink
or menu selections, branded materials
not company approved, dining room size,
ambient noise).
T
will work with you to:
Do Needs/Gap Assessment
of Speaker Program
Process
♦♦ Design & Implement
Effective Monitoring
Programs
♦♦ Conduct Field Monitoring
♦♦ Do Program Reporting &
Data Analysis
♦♦
To Learn More
Contact Cory LaBarge:
he location or activities going on at an event venue should not detract
from the educational program being held there. This is clearly why
the industry has long barred events from occurring at sporting events,
nightclubs, gentlemen’s clubs, etc. However, even if a location appears
appropriate, there may be problems that could have been avoided with a
little bit of prior due diligence:
♦♦ Specific budget limits or drink/meal selections. Companies should either
work with their third party event managers or interface directly with venues
in specific locations to educate them on your specific policy guidelines. Many
national upscale chain restaurants are familiar with these requirements since
they host numerous pharmaceutical company events and have private dining
rooms as part of their restaurant design; however, local private venues may not
be aware of your specific guidelines.
♦♦ Unapproved branded materials. We have sometimes observed restaurants
providing special menus containing branding elements, artwork or brand
names that were not company approved. Event managers or internal
personnel should ensure the venue does not prepare event table menus or
other materials with product information unless the company has reviewed
and approved their use prior to the event.
♦♦ Venue logistics. Companies should work with vendors and internal meeting
planners to choose venues that meet the needs of their specific group sizes and
have private dining facilities that are adequately shielded from external noise
or visibility to other diners not associated with the event.
[email protected]
435-213-5622
8
Common Compliance Challenges with Speaker Programs
©©Copyright 2015, Searchlight Compliance Advisors