Reviewing Pharmaceutical Marketing Materials

Question 1

What is the objective of promotion?

Answer 1

to maintain and promote the professional expertise of the HCP related to the correct use of medical products, as well as to promote patient safety

Question 2

what is product promotion?

Answer 2

any activity undertaken by a Company or on its behalf that promotes the prescription, supply, sale or administration of its products

Also depends on:

• perceived purpose
• how it’s used
• the consequences of use

Question 3

What are promotional materials?

Answer 3

all written, printed or audio/visual material descriptive of a product and its use published for use by healthcare providers containing product information supplied by a company.

• product brochures
• monographs
  -detailing cards,
• internet websites
• e-mails, letters
• medical sales aids
• presentations
  posters etc

Question 4

what are not promotional materials?

Answer 4

EPAR
SPC
package leaflet 
instructions for use
labelling 
reactive medical information enquiries

Question 5

what is a promotional claim?

Answer 5

any statement made or implied regarding the performance, efficacy, safety, quality of a product or nay other aspect suitable to promote it

comparative statements

Question 6

who is allowed to receive product promotion for POM?

Answer 6

• Doctors
• Pharmacists
• Nurses (depending on local regulations)

Question 7

who is not allowed to receive product promotion for POM?

Answer 7

Lay Public:

• General Public
• Patients
• Patient organisations

Question 8

To ensure compliance, where should information for product promotion comply to?

Answer 8

any claim made must be compliant with the SPC/IfU, irrespective of the source on which the claim is based.

the SPC/IfU is the KEY REF DOCUMENT-
non compliance with it is therefore OFF LABEL PROMOTION

Question 9

What was the European court decision in May 2011 RE compliance?

Answer 9

compliance does not mean that information provided in promotion must be contained in the SPC!

Question 10

What must all promotion material be?

Answer 10

• Accurate
• Balanced
• Up to date

Question 11

references are required, at least, for the following text parts:

Answer 11

• statements from clinical studies or publications
• quotations, citations
• graphs, figures, tables
• illustrations

Any statement made in promotion must be capable of substantiation.

Question 12

substantiating data and references

Answer 12

SPC, IfU
Most relevant docs for substantiation; no required to reference.

EPAR
Available for medicinal products licensed by centralised procedure only

Clinical studies
Must be compliant with SPC/IfU
Peer reviewed makes them a stronger ref

Abstracts/posters
they contain limited detail and often only prelim results, they may not be adequate substantiation, alone for a strong claim.
Not acceptable in all EU countries (e.g. Denmark, Finland, Italy)

Unpublished data
Only non confidential data can be used

Non-clinical data
e.g. prepared from in-vitro, lab or animal studies

can be used in promotion, where relevant, but

• type of study must be clearly indicated
• extrapolation to clinical situation must either be proven by data or avoided

Question 13

provision of substantiating data and references:

Answer 13

upon request

to customers, regulatory authorities, competitors

asap (within 10 working days)

Question 14

Artwork

Answer 14

• should be references
• should be faithfully reproduced: where adaptation or modification is required (e.g. for adaptation to SPC/IfU, to improve clarity), clearly state that the artwork has be ADAPTED AND/OR MODIFIED.
  where pub data are changed into artwork, state was : “calculated from”

must not mislead about the nature of a medicine

e.g. appropriate for the use in children, IV vs MI or oral use etc

must not mislead about a claim or comparison
e.g. by using incomplete or statistically irrelevant info or unusual scales