Code of Conduct - Question & Answers
March
2005
Question 1:
We recognise that "off-label" discussions regarding
products is strictly prohibited between HCP and Pharmaceutical
Representatives. What guidance can you provide on situations
whereby the HCP initiates "off-label" questions
that were unsolicited - can the Pharmaceutical Representative
respond to these queries. The FDA has certain criteria regarding
the discussion "off-label" discussion - is there
anything similar within Canada?
Response:
Questions from physicians regarding “off label”
use of approved medications should be forwarded to the companies
Medical Information department for response.
Question 2:
Can we use the product logo on a patient brochure destined
specifically for the patient taking a product; for instance,
a booklet prepared for one of our products which is intended
to help the patient use the medication appropriately and avoid
any administration error. Since this booklet is intended for
the patient already on the medication, the name of the product
appears throughout the text.
Response:
The fact that it is a patient's brochure that is destined
for a patient that is already taking THE product or, is being
prescribed THE product, the brochure may contain the product
logo. At this stage, it is fine because the patient has received
a prescription and it is his/her physician that has decided
to prescribe the product. The rule is that after a prescription,
the patient is allowed to get branded materials
On the other hand, no prescription = no branding.
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