Genentech Compliance Considerations – DVD Script (Male & Female)
Thank you for taking time today to learn more about what I think is
an effective therapy for the right patients…
Speaking at Genentech-directed education programs is an
excellent opportunity to share your knowledge with colleagues
eager to learn about the latest, most effective treatments. At the
same time, it is important to be aware of the differences between
speaking engagements that are planned and organized by
Genentech and independent medical education programs that
may or may not be supported by Genentech, but are conceived,
planned and implemented independently of the company.
In this brief presentation, we will describe a few differences
between these two types of programs and we will discuss how to
ensure that your presentations on behalf of Genentech are in
compliance with laws, regulations and policies.
Educational events that are planned and organized by Genentech
are not “independent” and therefore are considered “promotional.”
These events are regulated by the FDA and others.
Independent Medical Education events, usually CME, are guided
by the ACCME and other independent organizations. Genentech
does not have control over the selection of faculty, content, or
audience for these events.
Genentech is committed to supporting education of both types and
has established clear policies to comply with all laws and
The content of sponsored presentations must be consistent with,
and restricted to, the Prescribing Information or PI, which is also
referred to as “the approved label”, Genentech-approved materials,
such as slides, will be provided to you, and you must use them exclusively.
This differs from independent medical education, where content and materials are
entirely in the control of the education provider or faculty.
Genentech is responsible for inviting and confirming attendees to
the events at which you will be speaking. This, too, is different
from independent medical education, where the education
provider determines the audience.
Genentech-directed education events are funded by Genentech
and under the control of Genentech. Genentech is accountable for
Independent Medical Education events are owned by the
education provider or accrediting organization which organizes
them. They may or may not obtain funding from commercial
interests in the form of independent grants.
Both the guidelines for independent medical education, such as
those of the ACCME, the FDA and Genentech’s own policies
require fair balance in education.
All products have associated risks which must be disclosed. A
presentation which only discusses the positive aspects of a
therapy would be considered to be biased.
When speaking at a Genentech-directed educational event, you
must adhere to certain requirements, since, in the regulatory
context, you will be regarded as an agent of Genentech. The first
of these is disclosure of your financial interest…
This program is planned by Genentech and, as you might expect,
I’m being compensated for this talk. I should also disclose that I
have participated as a member of one of Genentech’s advisory boards…
…Well, fair balance is both a requirement and a useful tool to
organize how I address what I want to get across – and I know it’s
important to Genentech as well. I want to convey the whole
picture. I like to show – efficacy, administration, major adverse
events, and any warnings…
… In the pivotal trials that showed high efficacy, these two slides
show two significant adverse events through month 12… (pauses,
clicks) and one more through month 24.
Genentech is committed to helping you achieve fair balance in
your presentations. Not only is it an FDA requirement– it’s the right
thing to do.
To achieve fair balance, your presentation must include an
accurate and fair assessment of risks as well as the benefits. This
includes information about the product’s effectiveness,
contraindications and warnings, adverse effects, and administration
PHYSICIAN (consults notes) :
Let’s look at the demographics and baseline characteristics of the
patients in the Phase III clinical trials…
Genentech will provide you with an approved set of slides. You
must use at least the core set, if identified, in each talk you give.
You may not use your own materials.
Occasionally, people ask questions on off-label topics. I answer
VOICE FROM AUDIENCE: (don’t read)
What about the new data that came out last week showing that the
product may also be useful in advanced stages of the disease?…
Yes, I am familiar with that study. However, that use is not yet
approved by the FDA. Based on my clinical experience, I think
you may want to wait until its approval or you may wish to contact
Genentech’s Medical Communications department to see if they
have more information.
Speakers may answer questions based on their own clinical
experience, but must not proactively share information about the
product’s off-label uses.
Speakers may refer unsolicited off-label questions to Genentech’s
Medical Communications Department, or answer them at their
discretion, based on their own clinical experience. If you choose to
answer an off-label question, please:
• Refer to FAQs provided by Genentech when available
• Clearly indicate the use is not FDA-approved
• Tailor your response narrowly. Don’t address topics that
are not covered by the question, and
• Remember that responses to off-label questions must be
data-based and, as with other information you impart, must be fair balanced
It is your responsibility to lead discussion back to on-label uses.
One additional point: Genentech sales representatives who attend
a promotional event are not permitted to answer any questions raised during your presentation.
… I’ve found these events quite satisfying. I enjoy the peer contact
– those who come are interested in learning – and I think I’m
performing a useful function for the benefit of patients…
Well, thank you very much for coming. This is a therapy I’ve used
with some success, and I appreciate the opportunity to share what I’ve learned.
Thank you for agreeing to speak for Genentech. Your experience,
and adherence to the guidelines we’ve covered, can benefit other professionals