Demandez au CCPP

93

As follow-up to Question #91 and as referenced in question and answer #46, if the off-label content of the educational material (publication) is not the focus and will not be discussed by the rep, and that the reps are trained to use the material in a non-promotional manner, would this then comply to PAAB exemption?

You appear to be trying to create a grey area. The issue that you have to address is “Are you 'advertising' your product by the use of this material?”. The definition of advertising includes “promote the sale of a product”. If you are using the “educational” (no such designation exists in the regulations) material to promote the sale of your product then you are advertising. Health Canada has a guidance that says that if you link advertising and non-advertising materials then all of it becomes advertising. I suggest to stay away from the perception of promoting off-label information. There must be a valid source of information regarding the on label stuff if it found its way into the “educational” material. Many companies are setting policies to not let their sales reps distribute materials that are not intended for promotional use for perception and control reasons.

92

I have a question regarding minimum font size for safety and balancing copy. It is clear in the PAAB code that it is required to be 75% of the main claim in size. The reasons for this are obvious if one is producing a journal ad or printed piece – the balance copy must be legible.

However, if the APS is a 10 foot high panel, does the same ratio apply? In such a case, the balancing copy is almost beyond legible (too big) and consumes the entire bottom of the panel.

I am not aware of the 75% requirement being in the PAAB code. There is a requirement that advertising be accurate, complete and clear and contain fair balance to not mislead (s2.1) The proportion of 75% is a guideline used by review staff to help advertisers meet that requirement for most APS reviewed at the PAAB. Therefore, for a large exhibit panel we would recommend that the type size be large enough to be legible to a reader from an appropriate standing distance i.e. if they can get close to it to read it easily then it does not have to be 75% of the main body copy. It would depend on the booth size and the panel location.

91

Can sales representatives distribute educational materials that have been commissioned by their pharma company. The content of the educational material is produced by an independant expert faculty in a given disease area and content is reviewed by an University for balance & scientific integrity and endorsed as being deemed appropriate for Mainpro 2 or Section 2 credits. For reps to be able to distribute the information do the materials need to be reviewed by PAAB even though they are not promotional but rather educational?

Terminology is important because “advertising” is federally regulated. Therefore, the material is either “advertising” or “not advertising” for regulatory purpose. There is no such category as “educational” within the terminology of the law If the material has been produced independently and is to be distributed in its entirety without additional comment or editing by the company, it is exempt from PAAB review as per code s6.6. However, because of the context of the distribution (eg: drug rep), this may still be considered to be “advertising” if there is focus on the sponsor’s product in the content. As such, we suggest ensuring that there is no off label content in violation of the PAAB Code and federal law. The sales reps should be thoroughly trained on SOP to handle this material in a non-promotional manner. We can provide an opinion if they so choose to submit for opinion. Also see the Health Canada document
” The Distinction Between Advertising and Other Activities” for the section on distribution of advertising material related to CME/Symposiums see http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/index-eng.php with reference to the section that speaks about distribution of material after the event.

89

Would a live event whereby healthcare professionals are invited to hear key opinion leaders discuss unmet need in a therapeutic area and a drug that has just obtained NOC be deemed subject to preapproval by PAAB? The live events would be sponsored by the pharma company whose drug has just obtained NOC. The purpose would be to inform prescribers of the approved indications and appropriate clinical usage. The program would not be accredited.

This would be a promotional meeting and the meeting itself is not subject to PAAB review. However, if the pharma company sponsor provides slides to the speakers or materials to the meeting health professional attendees, they would be an Advertising/Promotional system (APS) subject to PAAB review. Prescribing information (could be a product monograph or a package insert) should be available at the meeting.

88

I understand that if a company decides to hand out the full PM instead of a PI, it is fine. My question is: Would a verbatim copy of part 1 and 3 of the PM (Health Professional Info and Consumer Info) also meet that requirement (i.e. the full PM but omitting Part 2).

Yes

87

We are producing a directory of canadian clinics that offer a specific test. There will be an introduction outlining why the test is important, how it is done etc. The booklet will be sponsored by a drug company (corporate logos will be on the cover) but there is nothing in it that mentions their or any other company’s drug products (and they have no affiliation with the tests, clinics or instruments used). The booklet will be distributed by the sponsors reps as a service. Healthcare providers will offer independent review of the content. Does this require PAAB review?

This item as described would not require PAAB review.

85

Could you please confirm for me whether or not a Dear Doctor letter outlining a Nursing Assessment program needs PAAB approval. The program is being run by a 3rd-party. The letter does not contain any information about product and it outlines the parameters of the program itself (i.e. # of patients needed to be recruited, length of day, etc.) The Dear Doctor letter is being left with the doctor and it is being delivered and signed by the representative.

This question is too vague for us to answer. We would need more details than this to give proper advice on its status regarding adverting law and the PAAB code. You can always call the PAAB Chief Review Officer Patrick Massad for free verbal advice; the PAAB charges a fee for written opinions including e-mail.

84

Recently the FDA issued new guidance for the distribution of medical journal articles and medical or scientific reference publications by drugmakers that address off-label uses of approved compounds. Among the new recommendations, the FDA stated that the drug manufacturers will no longer have to submit medical journal articles on unapproved new uses of cleared products to the FDA before distributing the studies to physicians. What influence will this have on HEalth Canada policy and what influence will this have on PAAB’s rules around distribution of these types of articles by drugmakers representatives.

Answer as of January 19, 2009 because it is time-sensitive. The U.S. FDA document is a “Guidance” out for comment and it is not law, so caution in interpreting it is needed. Also, it is very complex and you can see the whole thing at http://www.fda.gov/oc/op/goodreprint.html. There are lots of caveats and requirements to meet. Read the disclaimers carefully. This guidance replaces the FDAMA 401 provision that expired in 2006 (since 2000). The FDA has been wrestling this issue since then. Keep in mind the US government has changed to a Democrat driven government in both the presidency and the House, and Health Care reform is now the number two issue behind the economic situation. There are a number of hawks that are interested in reining in pharmaceutical industry marketing practices and several have spoken against this guidance. A new FDA Commissioner will be selected soon by the new House and we
will see what will be the new direction. Keep in mind Eli Lilly just got hit with a 1.4 billion dollar settlement for alleged criminal action regarding off-label promotion during the period 1999 to 2003. There are a number of other recent off-label cases that the Department of Justice and Office of the Inspector General (not the FDA) have acted on. I have recently asked Health Canada about any action in Canada to move in this direction and the answer is “no”. Remember that advertising laws in Canada are not the same as laws in the USA.