PHYSICIAN:
Thank you for taking time today to learn more about what I think is an effective therapy for the right patients…
VO NARRATOR:
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.
VO NARRATOR:
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 regulations.
VO NARRATOR:
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.
VO NARRATOR:
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.
VO NARRATOR:
Genentech-directed education events are funded by Genentech and under the control of Genentech. Genentech is accountable for them.
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.
VO NARRATOR:
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.
VO NARRATOR:
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…
PHYSICIAN:
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…
PHYSICIAN:
…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…
PHYSICIAN:
… 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.
VO NARRATOR:
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…
VO NARRATOR:
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.
PHYSICIAN:
Occasionally, people ask questions on off-label topics. I answer them narrowly…
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?…
PHYSICIAN:
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.
VO NARRATOR:
Speakers may answer questions based on their own clinical experience, but must not proactively share information about the product’s off-label uses.
VO NARRATOR:
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.
VO NARRATOR:
One additional point: Genentech sales representatives who attend a promotional event are not permitted to answer any questions raised during your presentation.
PHYSICIAN:
… 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…
PHYSICIAN:
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.
VO NARRATOR:
Thank you for agreeing to speak for Genentech. Your experience, and adherence to the guidelines we’ve covered, can benefit other professionals and patients.
