Regulatory Open Forum

Does anyone have approval qualifiers/notes/cautions in your marketing material review/approval process?  For example, if a piece is on the fence with respect to making an off-label claim based on semantic interpretation?  Obviously, if it is clearly off-label, it wouldn't be approved, but I'd like to allow reviewers to approve but note any concerns that have been advised to the Marketing team of potential ramifications of using proposed content as-is.  

Any examples or suggestions are greatly appreciated!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Hi Tina,

I think this is riskier than you think to leave "notes" regardless of what it is, even if it is something like "wording is not.acceptable at trade shows, etc"..

(Sorry, hard to think up every scenario that could show up in headlines or liability suits or enforcement actions.)

The piece does or does not meet the criteria set out for acceptance, in my opinion.  But each company has their risk acceptance. I just wouldn't do it, but know others who would.  Work with your marketing team offline to come up with acceptable statements and then approve those without notes. 


------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 09-Jul-2019 17:05
From: Tina O'Brien
Subject: Marketing material approval

Does anyone have approval qualifiers/notes/cautions in your marketing material review/approval process?  For example, if a piece is on the fence with respect to making an off-label claim based on semantic interpretation?  Obviously, if it is clearly off-label, it wouldn't be approved, but I'd like to allow reviewers to approve but note any concerns that have been advised to the Marketing team of potential ramifications of using proposed content as-is.

Any examples or suggestions are greatly appreciated!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

I agree. While allowing "approval with comments" is always tempting, it usually ends up causing more problems than it solves. Particularly in the US legal system, where any innocent comment can be contorted into completely something else, I'd stay away from it.

Ginger (the other one)

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 10-Jul-2019 08:01
From: Ginger Cantor
Subject: Marketing material approval

Hi Tina,

I think this is riskier than you think to leave "notes" regardless of what it is, even if it is something like "wording is not.acceptable at trade shows, etc"..

(Sorry, hard to think up every scenario that could show up in headlines or liability suits or enforcement actions.)

The piece does or does not meet the criteria set out for acceptance, in my opinion.  But each company has their risk acceptance. I just wouldn't do it, but know others who would.  Work with your marketing team offline to come up with acceptable statements and then approve those without notes.


------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 09-Jul-2019 17:05
From: Tina O'Brien
Subject: Marketing material approval

Does anyone have approval qualifiers/notes/cautions in your marketing material review/approval process?  For example, if a piece is on the fence with respect to making an off-label claim based on semantic interpretation?  Obviously, if it is clearly off-label, it wouldn't be approved, but I'd like to allow reviewers to approve but note any concerns that have been advised to the Marketing team of potential ramifications of using proposed content as-is.

Any examples or suggestions are greatly appreciated!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Thanks everyone!  I definitely need to put some additional thought to this.

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Original Message:
Sent: 11-Jul-2019 08:21
From: Ginger Glaser
Subject: Marketing material approval

I agree. While allowing "approval with comments" is always tempting, it usually ends up causing more problems than it solves. Particularly in the US legal system, where any innocent comment can be contorted into completely something else, I'd stay away from it.

Ginger (the other one)

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 10-Jul-2019 08:01
From: Ginger Cantor
Subject: Marketing material approval

Hi Tina,

I think this is riskier than you think to leave "notes" regardless of what it is, even if it is something like "wording is not.acceptable at trade shows, etc"..

(Sorry, hard to think up every scenario that could show up in headlines or liability suits or enforcement actions.)

The piece does or does not meet the criteria set out for acceptance, in my opinion.  But each company has their risk acceptance. I just wouldn't do it, but know others who would.  Work with your marketing team offline to come up with acceptable statements and then approve those without notes.


------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 09-Jul-2019 17:05
From: Tina O'Brien
Subject: Marketing material approval

Does anyone have approval qualifiers/notes/cautions in your marketing material review/approval process?  For example, if a piece is on the fence with respect to making an off-label claim based on semantic interpretation?  Obviously, if it is clearly off-label, it wouldn't be approved, but I'd like to allow reviewers to approve but note any concerns that have been advised to the Marketing team of potential ramifications of using proposed content as-is.

Any examples or suggestions are greatly appreciated!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

This message was posted by a user wishing to remain anonymous

With regards to claims, any claim that may have potential ramifications is not approved by our regulatory team. Especially if it is with a PMA device. But aside from claims, there has been marketing material that regulatory has voiced and noted concerns about but marketing has proceeded with using the material. An example was a piece of marketing material referencing Amy Schumer. As most know, Amy is a comedian and at times can be vulgar. Regulatory's concern was associating the company with someone that uses such vulgarity - how would that make the company look? While it really was not a regulatory compliance concern - it was still a concern I thought was worth documenting since some of the language she used in the piece could certainly make people uncomfortable (and marketing was not understanding my concern). I hope this helps!
Original Message:
Sent: 09-Jul-2019 17:05
From: Tina O'Brien
Subject: Marketing material approval

Does anyone have approval qualifiers/notes/cautions in your marketing material review/approval process?  For example, if a piece is on the fence with respect to making an off-label claim based on semantic interpretation?  Obviously, if it is clearly off-label, it wouldn't be approved, but I'd like to allow reviewers to approve but note any concerns that have been advised to the Marketing team of potential ramifications of using proposed content as-is.

Any examples or suggestions are greatly appreciated!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Thanks for that, Anon!  How did you document your opinion?  I'm thinking of adding such notes to our approval form so it can't be lost in the review notes to the originator.    (I love Amy Schumer, but totally agree that her material is not appropriate for device marketing, no matter how relevant)

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Original Message:
Sent: 10-Jul-2019 08:29
From: Anonymous Member
Subject: Marketing material approval

This message was posted by a user wishing to remain anonymous

With regards to claims, any claim that may have potential ramifications is not approved by our regulatory team. Especially if it is with a PMA device. But aside from claims, there has been marketing material that regulatory has voiced and noted concerns about but marketing has proceeded with using the material. An example was a piece of marketing material referencing Amy Schumer. As most know, Amy is a comedian and at times can be vulgar. Regulatory's concern was associating the company with someone that uses such vulgarity - how would that make the company look? While it really was not a regulatory compliance concern - it was still a concern I thought was worth documenting since some of the language she used in the piece could certainly make people uncomfortable (and marketing was not understanding my concern). I hope this helps!
Original Message:
Sent: 09-Jul-2019 17:05
From: Tina O'Brien
Subject: Marketing material approval

Does anyone have approval qualifiers/notes/cautions in your marketing material review/approval process?  For example, if a piece is on the fence with respect to making an off-label claim based on semantic interpretation?  Obviously, if it is clearly off-label, it wouldn't be approved, but I'd like to allow reviewers to approve but note any concerns that have been advised to the Marketing team of potential ramifications of using proposed content as-is.

Any examples or suggestions are greatly appreciated!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

We have an Agile Product Lifecycle management system and the Marketing Literature Change Orders (MLCO's) are approved in this system which allows for comments that can be seen in the history of the MLCO. 

Before any marketing literature goes in Agile, we have a meeting to discuss the proposed piece - edits are made based on regulatory and legals review and then the piece is submitted to Agile for documented approval. For the instance with Amy Schumer we really just didn't see eye to eye and that is why I found it fitting to add my comment prior to approval. 

I hope this information helps - best of luck!


------------------------------
Christine Stahley
Regulatory Affairs Analyst
Marlborough MA
United States
------------------------------

Original Message:
Sent: 10-Jul-2019 15:34
From: Tina O'Brien
Subject: Marketing material approval

Thanks for that, Anon!  How did you document your opinion?  I'm thinking of adding such notes to our approval form so it can't be lost in the review notes to the originator.    (I love Amy Schumer, but totally agree that her material is not appropriate for device marketing, no matter how relevant)

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 10-Jul-2019 08:29
From: Anonymous Member
Subject: Marketing material approval

This message was posted by a user wishing to remain anonymous

With regards to claims, any claim that may have potential ramifications is not approved by our regulatory team. Especially if it is with a PMA device. But aside from claims, there has been marketing material that regulatory has voiced and noted concerns about but marketing has proceeded with using the material. An example was a piece of marketing material referencing Amy Schumer. As most know, Amy is a comedian and at times can be vulgar. Regulatory's concern was associating the company with someone that uses such vulgarity - how would that make the company look? While it really was not a regulatory compliance concern - it was still a concern I thought was worth documenting since some of the language she used in the piece could certainly make people uncomfortable (and marketing was not understanding my concern). I hope this helps!
Original Message:
Sent: 09-Jul-2019 17:05
From: Tina O'Brien
Subject: Marketing material approval

Does anyone have approval qualifiers/notes/cautions in your marketing material review/approval process?  For example, if a piece is on the fence with respect to making an off-label claim based on semantic interpretation?  Obviously, if it is clearly off-label, it wouldn't be approved, but I'd like to allow reviewers to approve but note any concerns that have been advised to the Marketing team of potential ramifications of using proposed content as-is.

Any examples or suggestions are greatly appreciated!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Are you saying you had a meeting in which everyone was made aware of everyone else's concerns?  If everyone is already aware of them, what is the purpose in documenting them?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 11-Jul-2019 10:01
From: Christine Stahley
Subject: Marketing material approval

We have an Agile Product Lifecycle management system and the Marketing Literature Change Orders (MLCO's) are approved in this system which allows for comments that can be seen in the history of the MLCO.

Before any marketing literature goes in Agile, we have a meeting to discuss the proposed piece - edits are made based on regulatory and legals review and then the piece is submitted to Agile for documented approval. For the instance with Amy Schumer we really just didn't see eye to eye and that is why I found it fitting to add my comment prior to approval.

I hope this information helps - best of luck!


------------------------------
Christine Stahley
Regulatory Affairs Analyst
Marlborough MA
United States

Original Message:
Sent: 10-Jul-2019 15:34
From: Tina O'Brien
Subject: Marketing material approval

Thanks for that, Anon!  How did you document your opinion?  I'm thinking of adding such notes to our approval form so it can't be lost in the review notes to the originator.    (I love Amy Schumer, but totally agree that her material is not appropriate for device marketing, no matter how relevant)

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 10-Jul-2019 08:29
From: Anonymous Member
Subject: Marketing material approval

This message was posted by a user wishing to remain anonymous

With regards to claims, any claim that may have potential ramifications is not approved by our regulatory team. Especially if it is with a PMA device. But aside from claims, there has been marketing material that regulatory has voiced and noted concerns about but marketing has proceeded with using the material. An example was a piece of marketing material referencing Amy Schumer. As most know, Amy is a comedian and at times can be vulgar. Regulatory's concern was associating the company with someone that uses such vulgarity - how would that make the company look? While it really was not a regulatory compliance concern - it was still a concern I thought was worth documenting since some of the language she used in the piece could certainly make people uncomfortable (and marketing was not understanding my concern). I hope this helps!
Original Message:
Sent: 09-Jul-2019 17:05
From: Tina O'Brien
Subject: Marketing material approval

Does anyone have approval qualifiers/notes/cautions in your marketing material review/approval process?  For example, if a piece is on the fence with respect to making an off-label claim based on semantic interpretation?  Obviously, if it is clearly off-label, it wouldn't be approved, but I'd like to allow reviewers to approve but note any concerns that have been advised to the Marketing team of potential ramifications of using proposed content as-is.

Any examples or suggestions are greatly appreciated!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

In my experience, certain people are subject to short and/or selective memories, so documenting verbal discussions - particularly about things that could come back to haunt - is often warranted.

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Original Message:
Sent: 11-Jul-2019 19:16
From: Julie Omohundro
Subject: Marketing material approval

Are you saying you had a meeting in which everyone was made aware of everyone else's concerns?  If everyone is already aware of them, what is the purpose in documenting them?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 11-Jul-2019 10:01
From: Christine Stahley
Subject: Marketing material approval

We have an Agile Product Lifecycle management system and the Marketing Literature Change Orders (MLCO's) are approved in this system which allows for comments that can be seen in the history of the MLCO.

Before any marketing literature goes in Agile, we have a meeting to discuss the proposed piece - edits are made based on regulatory and legals review and then the piece is submitted to Agile for documented approval. For the instance with Amy Schumer we really just didn't see eye to eye and that is why I found it fitting to add my comment prior to approval.

I hope this information helps - best of luck!


------------------------------
Christine Stahley
Regulatory Affairs Analyst
Marlborough MA
United States

Original Message:
Sent: 10-Jul-2019 15:34
From: Tina O'Brien
Subject: Marketing material approval

Thanks for that, Anon!  How did you document your opinion?  I'm thinking of adding such notes to our approval form so it can't be lost in the review notes to the originator.    (I love Amy Schumer, but totally agree that her material is not appropriate for device marketing, no matter how relevant)

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 10-Jul-2019 08:29
From: Anonymous Member
Subject: Marketing material approval

This message was posted by a user wishing to remain anonymous

With regards to claims, any claim that may have potential ramifications is not approved by our regulatory team. Especially if it is with a PMA device. But aside from claims, there has been marketing material that regulatory has voiced and noted concerns about but marketing has proceeded with using the material. An example was a piece of marketing material referencing Amy Schumer. As most know, Amy is a comedian and at times can be vulgar. Regulatory's concern was associating the company with someone that uses such vulgarity - how would that make the company look? While it really was not a regulatory compliance concern - it was still a concern I thought was worth documenting since some of the language she used in the piece could certainly make people uncomfortable (and marketing was not understanding my concern). I hope this helps!
Original Message:
Sent: 09-Jul-2019 17:05
From: Tina O'Brien
Subject: Marketing material approval

Does anyone have approval qualifiers/notes/cautions in your marketing material review/approval process?  For example, if a piece is on the fence with respect to making an off-label claim based on semantic interpretation?  Obviously, if it is clearly off-label, it wouldn't be approved, but I'd like to allow reviewers to approve but note any concerns that have been advised to the Marketing team of potential ramifications of using proposed content as-is.

Any examples or suggestions are greatly appreciated!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

I guess it is hard to say without understanding the review and approval process at your company.

If RA has approval authority, then to me RA approves or doesn't approve, It doesn't approve and then caveat its approval.  If I felt comfortable enough with it to approve it, but thought the question of whether or not it is off label was a close call, I'd be more likely to write a memo to file documenting my rationale for concluding that it isn't off-label use, than write a note suggesting that I approved it even though I wasn't convinced it was not off-label use.



------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 11-Jul-2019 20:33
From: Tina O'Brien
Subject: Marketing material approval

In my experience, certain people are subject to short and/or selective memories, so documenting verbal discussions - particularly about things that could come back to haunt - is often warranted.

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 11-Jul-2019 19:16
From: Julie Omohundro
Subject: Marketing material approval

Are you saying you had a meeting in which everyone was made aware of everyone else's concerns?  If everyone is already aware of them, what is the purpose in documenting them?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 11-Jul-2019 10:01
From: Christine Stahley
Subject: Marketing material approval

We have an Agile Product Lifecycle management system and the Marketing Literature Change Orders (MLCO's) are approved in this system which allows for comments that can be seen in the history of the MLCO.

Before any marketing literature goes in Agile, we have a meeting to discuss the proposed piece - edits are made based on regulatory and legals review and then the piece is submitted to Agile for documented approval. For the instance with Amy Schumer we really just didn't see eye to eye and that is why I found it fitting to add my comment prior to approval.

I hope this information helps - best of luck!


------------------------------
Christine Stahley
Regulatory Affairs Analyst
Marlborough MA
United States

Original Message:
Sent: 10-Jul-2019 15:34
From: Tina O'Brien
Subject: Marketing material approval

Thanks for that, Anon!  How did you document your opinion?  I'm thinking of adding such notes to our approval form so it can't be lost in the review notes to the originator.    (I love Amy Schumer, but totally agree that her material is not appropriate for device marketing, no matter how relevant)

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 10-Jul-2019 08:29
From: Anonymous Member
Subject: Marketing material approval

This message was posted by a user wishing to remain anonymous

With regards to claims, any claim that may have potential ramifications is not approved by our regulatory team. Especially if it is with a PMA device. But aside from claims, there has been marketing material that regulatory has voiced and noted concerns about but marketing has proceeded with using the material. An example was a piece of marketing material referencing Amy Schumer. As most know, Amy is a comedian and at times can be vulgar. Regulatory's concern was associating the company with someone that uses such vulgarity - how would that make the company look? While it really was not a regulatory compliance concern - it was still a concern I thought was worth documenting since some of the language she used in the piece could certainly make people uncomfortable (and marketing was not understanding my concern). I hope this helps!
Original Message:
Sent: 09-Jul-2019 17:05
From: Tina O'Brien
Subject: Marketing material approval

Does anyone have approval qualifiers/notes/cautions in your marketing material review/approval process?  For example, if a piece is on the fence with respect to making an off-label claim based on semantic interpretation?  Obviously, if it is clearly off-label, it wouldn't be approved, but I'd like to allow reviewers to approve but note any concerns that have been advised to the Marketing team of potential ramifications of using proposed content as-is.

Any examples or suggestions are greatly appreciated!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

That said, I appreciate the matter of "short memories" and the range of situations and companies that RA personnel can find themselves in.  Ultimately, you are the one in the situation, so only you can weigh the alternatives with a full understanding of the situation, including internal dynamics at the company.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 11-Jul-2019 23:19
From: Julie Omohundro
Subject: Marketing material approval

I guess it is hard to say without understanding the review and approval process at your company.

If RA has approval authority, then to me RA approves or doesn't approve, It doesn't approve and then caveat its approval.  If I felt comfortable enough with it to approve it, but thought the question of whether or not it is off label was a close call, I'd be more likely to write a memo to file documenting my rationale for concluding that it isn't off-label use, than write a note suggesting that I approved it even though I wasn't convinced it was not off-label use.



------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 11-Jul-2019 20:33
From: Tina O'Brien
Subject: Marketing material approval

In my experience, certain people are subject to short and/or selective memories, so documenting verbal discussions - particularly about things that could come back to haunt - is often warranted.

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 11-Jul-2019 19:16
From: Julie Omohundro
Subject: Marketing material approval

Are you saying you had a meeting in which everyone was made aware of everyone else's concerns?  If everyone is already aware of them, what is the purpose in documenting them?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 11-Jul-2019 10:01
From: Christine Stahley
Subject: Marketing material approval

We have an Agile Product Lifecycle management system and the Marketing Literature Change Orders (MLCO's) are approved in this system which allows for comments that can be seen in the history of the MLCO.

Before any marketing literature goes in Agile, we have a meeting to discuss the proposed piece - edits are made based on regulatory and legals review and then the piece is submitted to Agile for documented approval. For the instance with Amy Schumer we really just didn't see eye to eye and that is why I found it fitting to add my comment prior to approval.

I hope this information helps - best of luck!


------------------------------
Christine Stahley
Regulatory Affairs Analyst
Marlborough MA
United States

Original Message:
Sent: 10-Jul-2019 15:34
From: Tina O'Brien
Subject: Marketing material approval

Thanks for that, Anon!  How did you document your opinion?  I'm thinking of adding such notes to our approval form so it can't be lost in the review notes to the originator.    (I love Amy Schumer, but totally agree that her material is not appropriate for device marketing, no matter how relevant)

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 10-Jul-2019 08:29
From: Anonymous Member
Subject: Marketing material approval

This message was posted by a user wishing to remain anonymous

With regards to claims, any claim that may have potential ramifications is not approved by our regulatory team. Especially if it is with a PMA device. But aside from claims, there has been marketing material that regulatory has voiced and noted concerns about but marketing has proceeded with using the material. An example was a piece of marketing material referencing Amy Schumer. As most know, Amy is a comedian and at times can be vulgar. Regulatory's concern was associating the company with someone that uses such vulgarity - how would that make the company look? While it really was not a regulatory compliance concern - it was still a concern I thought was worth documenting since some of the language she used in the piece could certainly make people uncomfortable (and marketing was not understanding my concern). I hope this helps!
Original Message:
Sent: 09-Jul-2019 17:05
From: Tina O'Brien
Subject: Marketing material approval

Does anyone have approval qualifiers/notes/cautions in your marketing material review/approval process?  For example, if a piece is on the fence with respect to making an off-label claim based on semantic interpretation?  Obviously, if it is clearly off-label, it wouldn't be approved, but I'd like to allow reviewers to approve but note any concerns that have been advised to the Marketing team of potential ramifications of using proposed content as-is.

Any examples or suggestions are greatly appreciated!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

I guess I don't get it. The entire point of having Regulatory reviews is to protect the company by providing relevant information on risks and regulatory requirements. I think the point being raised was necessary and correct. However, after the people presumably in charge of the company decided to take that PR risk, I don't really see how having the objections documented can help the company? Instead, it would seem like the only way it would ever be used in the future would be to "prove someone right" (not really a good goal for formal company documentation) or to hurt the company in a lawsuit, audit or due diligence process.

Now, I can totally see someone not being comfortable with signing off on something (even not directly related to RA) and of course I would not expect anyone to do so - most companies have sign off escalation processes specifically for situations in which a decision that someone disagrees with is being made "above their pay grade." I would totally support someone doing this, but I just don't see the value of having objections documented in the files.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 11-Jul-2019 10:01
From: Christine Stahley
Subject: Marketing material approval

We have an Agile Product Lifecycle management system and the Marketing Literature Change Orders (MLCO's) are approved in this system which allows for comments that can be seen in the history of the MLCO.

Before any marketing literature goes in Agile, we have a meeting to discuss the proposed piece - edits are made based on regulatory and legals review and then the piece is submitted to Agile for documented approval. For the instance with Amy Schumer we really just didn't see eye to eye and that is why I found it fitting to add my comment prior to approval.

I hope this information helps - best of luck!


------------------------------
Christine Stahley
Regulatory Affairs Analyst
Marlborough MA
United States

Original Message:
Sent: 10-Jul-2019 15:34
From: Tina O'Brien
Subject: Marketing material approval

Thanks for that, Anon!  How did you document your opinion?  I'm thinking of adding such notes to our approval form so it can't be lost in the review notes to the originator.    (I love Amy Schumer, but totally agree that her material is not appropriate for device marketing, no matter how relevant)

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 10-Jul-2019 08:29
From: Anonymous Member
Subject: Marketing material approval

This message was posted by a user wishing to remain anonymous

With regards to claims, any claim that may have potential ramifications is not approved by our regulatory team. Especially if it is with a PMA device. But aside from claims, there has been marketing material that regulatory has voiced and noted concerns about but marketing has proceeded with using the material. An example was a piece of marketing material referencing Amy Schumer. As most know, Amy is a comedian and at times can be vulgar. Regulatory's concern was associating the company with someone that uses such vulgarity - how would that make the company look? While it really was not a regulatory compliance concern - it was still a concern I thought was worth documenting since some of the language she used in the piece could certainly make people uncomfortable (and marketing was not understanding my concern). I hope this helps!
Original Message:
Sent: 09-Jul-2019 17:05
From: Tina O'Brien
Subject: Marketing material approval

Does anyone have approval qualifiers/notes/cautions in your marketing material review/approval process?  For example, if a piece is on the fence with respect to making an off-label claim based on semantic interpretation?  Obviously, if it is clearly off-label, it wouldn't be approved, but I'd like to allow reviewers to approve but note any concerns that have been advised to the Marketing team of potential ramifications of using proposed content as-is.

Any examples or suggestions are greatly appreciated!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Other Ginger here.....  

I have had situations where I did escalate a sign-off and marketing was pushing for it and I thought it was border misleading.   I made the Division RA Director sign-off on the advertising piece.   Refused to sign-off on it, and so did my direct manager.  Many many years ago.  But I did not leave comments in there saying that.

Good luck Tina

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 12-Jul-2019 09:57
From: Ginger Glaser
Subject: Marketing material approval

I guess I don't get it. The entire point of having Regulatory reviews is to protect the company by providing relevant information on risks and regulatory requirements. I think the point being raised was necessary and correct. However, after the people presumably in charge of the company decided to take that PR risk, I don't really see how having the objections documented can help the company? Instead, it would seem like the only way it would ever be used in the future would be to "prove someone right" (not really a good goal for formal company documentation) or to hurt the company in a lawsuit, audit or due diligence process.

Now, I can totally see someone not being comfortable with signing off on something (even not directly related to RA) and of course I would not expect anyone to do so - most companies have sign off escalation processes specifically for situations in which a decision that someone disagrees with is being made "above their pay grade." I would totally support someone doing this, but I just don't see the value of having objections documented in the files.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 11-Jul-2019 10:01
From: Christine Stahley
Subject: Marketing material approval

We have an Agile Product Lifecycle management system and the Marketing Literature Change Orders (MLCO's) are approved in this system which allows for comments that can be seen in the history of the MLCO.

Before any marketing literature goes in Agile, we have a meeting to discuss the proposed piece - edits are made based on regulatory and legals review and then the piece is submitted to Agile for documented approval. For the instance with Amy Schumer we really just didn't see eye to eye and that is why I found it fitting to add my comment prior to approval.

I hope this information helps - best of luck!


------------------------------
Christine Stahley
Regulatory Affairs Analyst
Marlborough MA
United States

Original Message:
Sent: 10-Jul-2019 15:34
From: Tina O'Brien
Subject: Marketing material approval

Thanks for that, Anon!  How did you document your opinion?  I'm thinking of adding such notes to our approval form so it can't be lost in the review notes to the originator.    (I love Amy Schumer, but totally agree that her material is not appropriate for device marketing, no matter how relevant)

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 10-Jul-2019 08:29
From: Anonymous Member
Subject: Marketing material approval

This message was posted by a user wishing to remain anonymous

With regards to claims, any claim that may have potential ramifications is not approved by our regulatory team. Especially if it is with a PMA device. But aside from claims, there has been marketing material that regulatory has voiced and noted concerns about but marketing has proceeded with using the material. An example was a piece of marketing material referencing Amy Schumer. As most know, Amy is a comedian and at times can be vulgar. Regulatory's concern was associating the company with someone that uses such vulgarity - how would that make the company look? While it really was not a regulatory compliance concern - it was still a concern I thought was worth documenting since some of the language she used in the piece could certainly make people uncomfortable (and marketing was not understanding my concern). I hope this helps!
Original Message:
Sent: 09-Jul-2019 17:05
From: Tina O'Brien
Subject: Marketing material approval

Does anyone have approval qualifiers/notes/cautions in your marketing material review/approval process?  For example, if a piece is on the fence with respect to making an off-label claim based on semantic interpretation?  Obviously, if it is clearly off-label, it wouldn't be approved, but I'd like to allow reviewers to approve but note any concerns that have been advised to the Marketing team of potential ramifications of using proposed content as-is.

Any examples or suggestions are greatly appreciated!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

I do not think it is good practice to allow "approved with comments". A piece is either approved or not approved. If it can be used in certain circumstances and not others, i would create a separate piece specifically for the intended use, and specify that it is only approved for use in that situation. Having a separate item number for it allows you to specify the acceptable use. 
Hope this helps!

------------------------------
Susan Shockey RAC
Senior Manager, Regulatory Affairs and Quality Management
CHARLESTON SC
United States
------------------------------

Original Message:
Sent: 09-Jul-2019 17:05
From: Tina O'Brien
Subject: Marketing material approval

Does anyone have approval qualifiers/notes/cautions in your marketing material review/approval process?  For example, if a piece is on the fence with respect to making an off-label claim based on semantic interpretation?  Obviously, if it is clearly off-label, it wouldn't be approved, but I'd like to allow reviewers to approve but note any concerns that have been advised to the Marketing team of potential ramifications of using proposed content as-is.

Any examples or suggestions are greatly appreciated!

Tina

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------