Regulatory Open Forum

Fellow Members,

I am sure at one time or another you have all encountered challenges with Management and QA/RA policies. My current "challenge" is the view from management that promotional material is not subject to regulatory oversight as labeling. How has anyone else overcome this challenge with labeling? (I have already cited FDA/ISO guidance and standards)  Thanks you.
-------------------------------------------
Vicki Gail
QA / RA Manager
Agoura Hills CA
United States
-------------------------------------------

IMHO:  Such challenges should be viewed as a fuel that keeps you moving forward.  The result is not everything but what leads to the result is everything.  You have informed the management and even shown all the documents to the management and thus, you have controlled everything.  Forget the rest!!!

Please use the following for your benefit though.

Labeling is extremely broad, of course covering promotional materials.  However, as long as your dissemination of information is done in a way to be compliant with the relevant and applicable regulations and guidance [inter alia, 21 CFR Part 99 and the FDA's recent guidance document (issued Dec. 2011; to be finalized though)], as an example, Agency is unwilling to interpret your activities as "evidence of your firm's intent" that the product be used unlawfully.  

As far as labeling practice is concerned, generally and arguably speaking, the management chooses to get reactive rather than proactive.      

If you hit a brick wall or come up against a brick wall, you are unable to continue or make progress because something stops or will stop you.

My suggestion/recommendation:

Please talk to your supervisor with a nurturing tone, who should/will then escalate the issue to the management.  Open discussion, increased awareness and frequent training need to happen, inter alia! 

Thanks.

-------------------------------------------
www.RegulatoryDoctor.com
United States
-------------------------------------------






Original Message:
Sent: 07-12-2012 14:20
From: Vicki Gail
Subject: Promotional Material Control as Labeling

Fellow Members,

I am sure at one time or another you have all encountered challenges with Management and QA/RA policies. My current "challenge" is the view from management that promotional material is not subject to regulatory oversight as labeling. How has anyone else overcome this challenge with labeling? (I have already cited FDA/ISO guidance and standards)  Thanks you.
-------------------------------------------
Vicki Gail
QA / RA Manager
Agoura Hills CA
United States
-------------------------------------------

Hi Vicki,

I work for a small company that was hit by the "Bad Ad" program under DDMAC.  If I understand you question correctly it sounds like management doesn't think that promotional material is related to labeling therefore Regulatory should not be involved.  If I am correct then management needs to adjust quickly.  For promotional items the Fair / Balance option and media is critical with respect to what you have in your label.  If you state anything in your promo ad / media that is not in your label... red flag!!  Don't forget DDMAC was promoted to OPDP (Office of Prescription Drug Promotion) so their scope for reviewing promotional material just got bigger with more scrutiny. 

To overcome this misunderstanding at my company I have our lawyer involved. 

If I misunderstood your question, my apologies. 

-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
-------------------------------------------






Original Message:
Sent: 07-12-2012 14:20
From: Vicki Gail
Subject: Promotional Material Control as Labeling

Fellow Members,

I am sure at one time or another you have all encountered challenges with Management and QA/RA policies. My current "challenge" is the view from management that promotional material is not subject to regulatory oversight as labeling. How has anyone else overcome this challenge with labeling? (I have already cited FDA/ISO guidance and standards)  Thanks you.
-------------------------------------------
Vicki Gail
QA / RA Manager
Agoura Hills CA
United States
-------------------------------------------

Just so I understand the question well: Is the question that promotional materials are not subject to oversight or the labeling is not subject to oversight?

-------------------------------------------
PRAFULLA AGRAWALA
KENDALL PARK NJ
United States
-------------------------------------------






Original Message:
Sent: 07-12-2012 14:20
From: Vicki Gail
Subject: Promotional Material Control as Labeling

Fellow Members,

I am sure at one time or another you have all encountered challenges with Management and QA/RA policies. My current "challenge" is the view from management that promotional material is not subject to regulatory oversight as labeling. How has anyone else overcome this challenge with labeling? (I have already cited FDA/ISO guidance and standards)  Thanks you.
-------------------------------------------
Vicki Gail
QA / RA Manager
Agoura Hills CA
United States
-------------------------------------------

My recommendation is to provide your management with some recent examples of hefty fines that some pharma companies have paid for false promotion.  There is one recent news story (I believe it was GSK) and frankly, I'm surprised your management is not aware.

-------------------------------------------
Richard Shansky PHD
Group Director, Regulatory Affairs-CMC
Shire
Lexington MA
United States
-------------------------------------------






Original Message:
Sent: 07-12-2012 14:20
From: Vicki Gail
Subject: Promotional Material Control as Labeling

Fellow Members,

I am sure at one time or another you have all encountered challenges with Management and QA/RA policies. My current "challenge" is the view from management that promotional material is not subject to regulatory oversight as labeling. How has anyone else overcome this challenge with labeling? (I have already cited FDA/ISO guidance and standards)  Thanks you.
-------------------------------------------
Vicki Gail
QA / RA Manager
Agoura Hills CA
United States
-------------------------------------------

Vicki - One suggestion would be to show them (management) warning letters that other companies have received related to promotional materials.  There are several examples of warning letters related to promotions.  This would be a scare tactic, but it is also good evidence based examples of issues.  There's a link to an article about Pharma promotions below, but OPDP also reviews device advertising.

http://www.policymed.com/2012/07/fda-outlines-warning-letters-for-promotion-of-prescription-pharmaceuticals.html 

I completely understand where you are coming from in terms of this "challenge".  We had a consultant come speak to our marketing and engineering groups about this topic.

I heard today, from another colleague, that the FDASIA includes a requirement that the the FDA must come-out with guidance on all web promotions. 

I hope this helps.

Regards,

-------------------------------------------
Alyssa Thomas
Regulatory Supervisor
Acumed LLC
Hillsboro OR
United States
-------------------------------------------






Original Message:
Sent: 07-12-2012 14:20
From: Vicki Gail
Subject: Promotional Material Control as Labeling

Fellow Members,

I am sure at one time or another you have all encountered challenges with Management and QA/RA policies. My current "challenge" is the view from management that promotional material is not subject to regulatory oversight as labeling. How has anyone else overcome this challenge with labeling? (I have already cited FDA/ISO guidance and standards)  Thanks you.
-------------------------------------------
Vicki Gail
QA / RA Manager
Agoura Hills CA
United States
-------------------------------------------

Dear Vicki,
I am sure you are getting back supportive comments. You are completely correct that promotional material is a type of 'labeling'.  If you are in the Pharma world - FDA has to reach and approve your material BEFORE it is released.  In Device, it does not have the FDA review step, but it must be consistent with your current approved label. Any performance data needs to be from your IFU, the 510k, or at least a specific internal test/clinical trial.  I often 'teach by Warning Letter'.  These are pretty helpful to point out the problems with ignoring regulatory standards. If you need some help finding a good one - please let me know and I can help. Good Luck! You're doing the right thing.

-------------------------------------------
Rob Newman RAC
VP Regulatory Affairs
Menlo Park CA
United States
-------------------------------------------


Original Message:
Sent: 07-12-2012 14:20
From: Vicki Gail
Subject: Promotional Material Control as Labeling

Fellow Members,

I am sure at one time or another you have all encountered challenges with Management and QA/RA policies. My current "challenge" is the view from management that promotional material is not subject to regulatory oversight as labeling. How has anyone else overcome this challenge with labeling? (I have already cited FDA/ISO guidance and standards)  Thanks you.
-------------------------------------------
Vicki Gail
QA / RA Manager
Agoura Hills CA
United States
-------------------------------------------

Rob and Vickie, FDCA does not give FDA the authority to require the submission of any pharma promotional material for approval prior to release except the limited situations allowed by the FDAAA of 1997 or for subpart H approved drugs. Vickie, does your company at least have a rigorous Medical Legal Review of promotional materials? Many companies also separate the regulatory oversight into a post marketing regulatory group as opposed to those who do the IND/NDA oversight. The Code of Federal Regulations also includes promotional materials as labeling and some sort of rigorous internal review of materials to insure compliance with the ad and promo regulations and guidances is essential. ------------------------------------------- Alan Bergstrom Senior Director Daiichi Sankyo, Inc. Parsippany NJ United States -------------------------------------------
Original Message: Sent: 07-14-2012 15:36 From: Rob Newman Subject: Promotional Material Control as Labeling Dear Vicki, I am sure you are getting back supportive comments. You are completely correct that promotional material is a type of 'labeling'. If you are in the Pharma world - FDA has to reach and approve your material BEFORE it is released. In Device, it does not have the FDA review step, but it must be consistent with your current approved label. Any performance data needs to be from your IFU, the 510k, or at least a specific internal test/clinical trial. I often 'teach by Warning Letter'. These are pretty helpful to point out the problems with ignoring regulatory standards. If you need some help finding a good one - please let me know and I can help. Good Luck! You're doing the right thing. ------------------------------------------- Rob Newman RAC VP Regulatory Affairs Menlo Park CA United States -------------------------------------------
Original Message: Sent: 07-12-2012 14:20 From: Vicki Gail Subject: Promotional Material Control as Labeling Fellow Members, I am sure at one time or another you have all encountered challenges with Management and QA/RA policies. My current "challenge" is the view from management that promotional material is not subject to regulatory oversight as labeling. How has anyone else overcome this challenge with labeling? (I have already cited FDA/ISO guidance and standards) Thanks you. ------------------------------------------- Vicki Gail QA / RA Manager Agoura Hills CA United States -------------------------------------------

Hi Alan,

You are correct, however, in light of the process for promotional material and approved labeling Health Canada, in certain cases, requires acceptance before release of the promotional material under PAAB.    Not sure about other agencies but my current experience has shown that since we are in the US some people assume that a review process under FDA is the same for other agencies when it isn't.


-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
-------------------------------------------






Original Message:
Sent: 07-15-2012 13:29
From: Alan Bergstrom
Subject: Promotional Material Control as Labeling


Rob and Vickie,
FDCA does not give FDA the authority to require the submission of any pharma promotional material for approval prior to release except the limited situations allowed by the FDAAA of 1997 or for subpart H approved drugs.
Vickie, does your company at least have a rigorous Medical Legal Review of promotional materials? Many companies also separate the regulatory oversight into a post marketing regulatory group as opposed to those who do the IND/NDA oversight.
The Code of Federal Regulations also includes promotional materials as labeling and some sort of rigorous internal review of materials to insure compliance with the ad and promo regulations and guidances is essential.
-------------------------------------------
Alan Bergstrom
Senior Director
Daiichi Sankyo, Inc.
Parsippany NJ
United States
-------------------------------------------

I should be more careful befroe hitting send. FDAAA was signed into law in 2007, not 1997.

-------------------------------------------
Alan Bergstrom
Senior Director
Daiichi Sankyo, Inc.
Parsippany NJ
United States
-------------------------------------------






Original Message:
Sent: 07-15-2012 13:29
From: Alan Bergstrom
Subject: Promotional Material Control as Labeling


Rob and Vickie,
FDCA does not give FDA the authority to require the submission of any pharma promotional material for approval prior to release except the limited situations allowed by the FDAAA of 1997 or for subpart H approved drugs.
Vickie, does your company at least have a rigorous Medical Legal Review of promotional materials? Many companies also separate the regulatory oversight into a post marketing regulatory group as opposed to those who do the IND/NDA oversight.
The Code of Federal Regulations also includes promotional materials as labeling and some sort of rigorous internal review of materials to insure compliance with the ad and promo regulations and guidances is essential.
-------------------------------------------
Alan Bergstrom
Senior Director
Daiichi Sankyo, Inc.
Parsippany NJ
United States
-------------------------------------------

Alan:

OK, we get it and context matters.

FDAMA 1997
FDAAA 2007

Significant amendments made to the FD&C Act can be found here.
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/default.htm



-------------------------------------------
www.RegulatoryDoctor.com
Floyd VA
United States
-------------------------------------------






Original Message:
Sent: 07-16-2012 08:58
From: Alan Bergstrom
Subject: Promotional Material Control as Labeling

I should be more careful befroe hitting send. FDAAA was signed into law in 2007, not 1997.

-------------------------------------------
Alan Bergstrom
Senior Director
Daiichi Sankyo, Inc.
Parsippany NJ
United States
-------------------------------------------






Original Message:
Sent: 07-15-2012 13:29
From: Alan Bergstrom
Subject: Promotional Material Control as Labeling


Rob and Vickie,
FDCA does not give FDA the authority to require the submission of any pharma promotional material for approval prior to release except the limited situations allowed by the FDAAA of 1997 or for subpart H approved drugs.
Vickie, does your company at least have a rigorous Medical Legal Review of promotional materials? Many companies also separate the regulatory oversight into a post marketing regulatory group as opposed to those who do the IND/NDA oversight.
The Code of Federal Regulations also includes promotional materials as labeling and some sort of rigorous internal review of materials to insure compliance with the ad and promo regulations and guidances is essential.
-------------------------------------------
Alan Bergstrom
Senior Director
Daiichi Sankyo, Inc.
Parsippany NJ
United States
-------------------------------------------

Rob and Vickie Forgot to include that there is a requirement to submit ad and promo materials to OPDP under cover of form 2253 at time of first use but this is not because FDA "approves" the material upon receipt. It is simply a post marketing filing requirement of 21 CFR 314.81(b)(3)(i). ------------------------------------------- Alan Bergstrom Senior Director Daiichi Sankyo, Inc. Parsippany NJ United States -------------------------------------------
Original Message: Sent: 07-14-2012 15:36 From: Rob Newman Subject: Promotional Material Control as Labeling Dear Vicki, I am sure you are getting back supportive comments. You are completely correct that promotional material is a type of 'labeling'. If you are in the Pharma world - FDA has to reach and approve your material BEFORE it is released. In Device, it does not have the FDA review step, but it must be consistent with your current approved label. Any performance data needs to be from your IFU, the 510k, or at least a specific internal test/clinical trial. I often 'teach by Warning Letter'. These are pretty helpful to point out the problems with ignoring regulatory standards. If you need some help finding a good one - please let me know and I can help. Good Luck! You're doing the right thing. ------------------------------------------- Rob Newman RAC VP Regulatory Affairs Menlo Park CA United States -------------------------------------------
Original Message: Sent: 07-12-2012 14:20 From: Vicki Gail Subject: Promotional Material Control as Labeling Fellow Members, I am sure at one time or another you have all encountered challenges with Management and QA/RA policies. My current "challenge" is the view from management that promotional material is not subject to regulatory oversight as labeling. How has anyone else overcome this challenge with labeling? (I have already cited FDA/ISO guidance and standards) Thanks you. ------------------------------------------- Vicki Gail QA / RA Manager Agoura Hills CA United States -------------------------------------------

Everyone - thank you for all your input! This is great information.

To add some clarifying details - We market a Class II permanent implant medical device.   Our labeling SOP is pretty rigourous on product provided labeling and more general on promotional materials. Our marketing department has been promoting our products without much oversight from our QA/RA department in such locations as Facebook, Twitter, YouTube, magazine, trade shows. etc. 

I revised our SOP to include a more in depth review of promotional materials that include a prodcut claim (i.e. Our product is 10x stronger than any of the competition).  Any promotional material not making a product claim is excluded from any review. (i.e. Come visit our booth at the XYZ trade show)

I am being told by management that a QA/RA review items that promote a claim of our product , such as postings on social media, training binders & videos, competitive comparisons provided to sales reps, trade show presentations and banners is overly burdensome to the maketing department.

Herein lies my challenge to bring management on board to promotional material review.
-------------------------------------------
Vicki Gail
QA / RA Manager
Agoura Hills CA
United States
-------------------------------------------






Original Message:
Sent: 07-12-2012 14:20
From: Vicki Gail
Subject: Promotional Material Control as Labeling

Fellow Members,

I am sure at one time or another you have all encountered challenges with Management and QA/RA policies. My current "challenge" is the view from management that promotional material is not subject to regulatory oversight as labeling. How has anyone else overcome this challenge with labeling? (I have already cited FDA/ISO guidance and standards)  Thanks you.
-------------------------------------------
Vicki Gail
QA / RA Manager
Agoura Hills CA
United States
-------------------------------------------

Hi Vicki, I've certainly heard the 'overly burdensome' in my career as well. Any time there are claims, regulatory should review. This is where we trot out the recent cases where large companies have had large fines levied against them for bad claims. Every time I come across these cases, I make sure to email them to upper management and marketing managers as training/FYI. This gives them some perspective as to why they might WANT regulatory review, rather than finding it burdensome. We are there to protect the company, not just be cops.
Original Message----- From: Vicki Gail [mailto:noreply@egroups.raps.org] Sent: Monday, July 16, 2012 10:21 AM To: Corey Jaseph Subject: Regulatory Open Forum: RE:Promotional Material Control as Labeling Everyone - thank you for all your input! This is great information. To add some clarifying details - We market a Class II permanent implant medical device. Our labeling SOP is pretty rigourous on product provided labeling and more general on promotional materials. Our marketing department has been promoting our products without much oversight from our QA/RA department in such locations as Facebook, Twitter, YouTube, magazine, trade shows. etc. I revised our SOP to include a more in depth review of promotional materials that include a prodcut claim (i.e. Our product is 10x stronger than any of the competition). Any promotional material not making a product claim is excluded from any review. (i.e. Come visit our booth at the XYZ trade show) I am being told by management that a QA/RA review items that promote a claim of our product , such as postings on social media, training binders & videos, competitive comparisons provided to sales reps, trade show presentations and banners is overly burdensome to the maketing department. Herein lies my challenge to bring management on board to promotional material review. ------------------------------------------- Vicki Gail QA / RA Manager Agoura Hills CA United States -------------------------------------------

You've gotten some great advice. Here is my bottom line:

21 CFR Part 1 defines labeling to include "all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce."  That has been the definition for decades.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1.3
See also 21 CFR Part 99 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=99&showFR=1. Accompaning does not necessarily mean physically accompanying: companies have tried to ship items separately but the courst have seen through this obvious ruse.  Your management is, perhaps willingly, confusing this with "label" which is the container wrapping.  Labeling is EVERYTHING else, from Video News Releases to radio ads to mailers to magazines, and has been for decades. This year FDA went after a company, Premier Micronutrient, who got an ad published as a news release on prnewswire.com.  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm253423.htm

The Quality Unit clears labeling under 820.1 and 820.3.  It's a component.  See also 820.86 and 120. The design history has to address it as design output.  It has to be covered in complaints under 820.198.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

Also under 801.4, your company also establishes an "Intended Use" by its labeling, including the promotional material.  As such, a product with unapproved uses discussed on the promotional material is misbranded, because it is not properly LABELED (on the immediate container) for its intended use. See 801.6.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=801&showFR=1.

Under 807.3, this makes the party a facility requiring registration.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=807&showFR=1

Under 809.10, if this is an IVD, all the labeling must contain all the information listed in the regulation:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=809&showFR=1


Under 803, you'd have to report Adverse events for anything related to claims on this material under 803.3:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803&showFR=1  Also see 806.2, where changing the labeling (including promotional material) covers them under this part:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=806&showFR=1

If its subject to a standard under 861.1, it has much less lee-way to modify its labeling and will lose the benefit of the standard by deviating from it.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=861&showFR=1

If the device is subject to tracking (or if it's currently not subject to tracking) violations can result when the labeling is changed under 821. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=821&showFR=1

If it's not labeling, then its advertising, which is regulated for OTC devices by FTC.  FTC's remedies cost at least as much as FDA's, and they often respond faster.  Under the FTC's Lanham Act, the company is also liable to competitors who can and do sue for damages without waiting for the FTC.

Finally, by selling the product to states, the VA, sCHIPS, Medicaid, and Medicare (probably 60%-80% of your customers if you are an average company), then you are guilty of overutilization for selling for these uses and you will have to eventually "disgorge" three times (3X) these sales back to the government.  That's what happened to GSK when it had to pay $3 Billion.  Individual corporate officers had to defend themselves in criminal court. You should argue that you are saving them, the company and the investors of this painful process.  You can see all the Corporate Integrity Agreements for drugs and device companies here:  http://oig.hhs.gov/compliance/corporate-integrity-agreements/cia-documents.asp

-------------------------------------------
Andrea Chamblee RAC, FRAPS
Director
FDA
Rockville MD
United States
-------------------------------------------






Original Message:
Sent: 07-12-2012 14:20
From: Vicki Gail
Subject: Promotional Material Control as Labeling

Fellow Members,

I am sure at one time or another you have all encountered challenges with Management and QA/RA policies. My current "challenge" is the view from management that promotional material is not subject to regulatory oversight as labeling. How has anyone else overcome this challenge with labeling? (I have already cited FDA/ISO guidance and standards)  Thanks you.
-------------------------------------------
Vicki Gail
QA / RA Manager
Agoura Hills CA
United States
-------------------------------------------

Just to add one more to the list by Andrea:

See 21 CFR Part 806 Reports of corrections and removals.
When a device is determined to be misbranded or adulterated and when FDA considers to be in violation of the FD&C Act and against which FDA would initiate legal action, a firm takes a voluntary action (recall:  correction or removal of a marketed product).   

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=806.10 

Please note:  No report of correction or removal is required under 21 CFR Part 806, if a report of the correction or removal is required and has been submitted under 21 CFR Parts 803 or 1004.

-------------------------------------------
www.RegulatoryDoctor.com
Floyd VA
United States
-------------------------------------------






Original Message:
Sent: 07-17-2012 10:15
From: Andrea Chamblee
Subject: Promotional Material Control as Labeling

You've gotten some great advice. Here is my bottom line:

21 CFR Part 1 defines labeling to include "all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce."  That has been the definition for decades.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1.3
See also 21 CFR Part 99 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=99&showFR=1. Accompaning does not necessarily mean physically accompanying: companies have tried to ship items separately but the courst have seen through this obvious ruse.  Your management is, perhaps willingly, confusing this with "label" which is the container wrapping.  Labeling is EVERYTHING else, from Video News Releases to radio ads to mailers to magazines, and has been for decades. This year FDA went after a company, Premier Micronutrient, who got an ad published as a news release on prnewswire.com.  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm253423.htm

The Quality Unit clears labeling under 820.1 and 820.3.  It's a component.  See also 820.86 and 120. The design history has to address it as design output.  It has to be covered in complaints under 820.198.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

Also under 801.4, your company also establishes an "Intended Use" by its labeling, including the promotional material.  As such, a product with unapproved uses discussed on the promotional material is misbranded, because it is not properly LABELED (on the immediate container) for its intended use. See 801.6.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=801&showFR=1.

Under 807.3, this makes the party a facility requiring registration.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=807&showFR=1

Under 809.10, if this is an IVD, all the labeling must contain all the information listed in the regulation:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=809&showFR=1


Under 803, you'd have to report Adverse events for anything related to claims on this material under 803.3:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803&showFR=1  Also see 806.2, where changing the labeling (including promotional material) covers them under this part:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=806&showFR=1

If its subject to a standard under 861.1, it has much less lee-way to modify its labeling and will lose the benefit of the standard by deviating from it.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=861&showFR=1

If the device is subject to tracking (or if it's currently not subject to tracking) violations can result when the labeling is changed under 821. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=821&showFR=1

If it's not labeling, then its advertising, which is regulated for OTC devices by FTC.  FTC's remedies cost at least as much as FDA's, and they often respond faster.  Under the FTC's Lanham Act, the company is also liable to competitors who can and do sue for damages without waiting for the FTC.

Finally, by selling the product to states, the VA, sCHIPS, Medicaid, and Medicare (probably 60%-80% of your customers if you are an average company), then you are guilty of overutilization for selling for these uses and you will have to eventually "disgorge" three times (3X) these sales back to the government.  That's what happened to GSK when it had to pay $3 Billion.  Individual corporate officers had to defend themselves in criminal court. You should argue that you are saving them, the company and the investors of this painful process.  You can see all the Corporate Integrity Agreements for drugs and device companies here:  http://oig.hhs.gov/compliance/corporate-integrity-agreements/cia-documents.asp

-------------------------------------------
Andrea Chamblee RAC, FRAPS
Director
FDA
Rockville MD
United States
-------------------------------------------






Original Message:
Sent: 07-12-2012 14:20
From: Vicki Gail
Subject: Promotional Material Control as Labeling

Fellow Members,

I am sure at one time or another you have all encountered challenges with Management and QA/RA policies. My current "challenge" is the view from management that promotional material is not subject to regulatory oversight as labeling. How has anyone else overcome this challenge with labeling? (I have already cited FDA/ISO guidance and standards)  Thanks you.
-------------------------------------------
Vicki Gail
QA / RA Manager
Agoura Hills CA
United States
-------------------------------------------

Thanks you for adding the recall regulation. How could I forget -- I had that page open but left it off in the flurry. Here's an example you can give your company -- this company sent out promotional material for an off-labeled use for its device and had to call each company and ask for it back - expensive, embarrasing, and a very good way to lose credibility: 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=53649

" Reason for Recall:   Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use. 

Action: Customers were notified by letter on 05/02/2007 and asked to remove the software program from any computers on which it had been installed and return the software disc and User's Guide to Meretek."

Reason for Recall	Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.
Action	Customers were notified by letter on 05/02/2007 and asked to remove the software program from any computers on which it had been installed and return the software disc and User's Guide to Meretek.

Original Message:
Sent: 07-17-2012 10:40
From: Chang Lim
Subject: Promotional Material Control as Labeling

Just to add one more to the list by Andrea:

See 21 CFR Part 806 Reports of corrections and removals.
When a device is determined to be misbranded or adulterated and when FDA considers to be in violation of the FD&C Act and against which FDA would initiate legal action, a firm takes a voluntary action (recall:  correction or removal of a marketed product).   

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=806.10 

Please note:  No report of correction or removal is required under 21 CFR Part 806, if a report of the correction or removal is required and has been submitted under 21 CFR Parts 803 or 1004.

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www.RegulatoryDoctor.com
Floyd VA
United States
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Original Message:
Sent: 07-17-2012 10:15
From: Andrea Chamblee
Subject: Promotional Material Control as Labeling

You've gotten some great advice. Here is my bottom line:

21 CFR Part 1 defines labeling to include "all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce."  That has been the definition for decades.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1.3
See also 21 CFR Part 99 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=99&showFR=1. Accompaning does not necessarily mean physically accompanying: companies have tried to ship items separately but the courst have seen through this obvious ruse.  Your management is, perhaps willingly, confusing this with "label" which is the container wrapping.  Labeling is EVERYTHING else, from Video News Releases to radio ads to mailers to magazines, and has been for decades. This year FDA went after a company, Premier Micronutrient, who got an ad published as a news release on prnewswire.com.  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm253423.htm

The Quality Unit clears labeling under 820.1 and 820.3.  It's a component.  See also 820.86 and 120. The design history has to address it as design output.  It has to be covered in complaints under 820.198.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

Also under 801.4, your company also establishes an "Intended Use" by its labeling, including the promotional material.  As such, a product with unapproved uses discussed on the promotional material is misbranded, because it is not properly LABELED (on the immediate container) for its intended use. See 801.6.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=801&showFR=1.

Under 807.3, this makes the party a facility requiring registration.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=807&showFR=1

Under 809.10, if this is an IVD, all the labeling must contain all the information listed in the regulation:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=809&showFR=1


Under 803, you'd have to report Adverse events for anything related to claims on this material under 803.3:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803&showFR=1  Also see 806.2, where changing the labeling (including promotional material) covers them under this part:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=806&showFR=1

If its subject to a standard under 861.1, it has much less lee-way to modify its labeling and will lose the benefit of the standard by deviating from it.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=861&showFR=1

If the device is subject to tracking (or if it's currently not subject to tracking) violations can result when the labeling is changed under 821. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=821&showFR=1

If it's not labeling, then its advertising, which is regulated for OTC devices by FTC.  FTC's remedies cost at least as much as FDA's, and they often respond faster.  Under the FTC's Lanham Act, the company is also liable to competitors who can and do sue for damages without waiting for the FTC.

Finally, by selling the product to states, the VA, sCHIPS, Medicaid, and Medicare (probably 60%-80% of your customers if you are an average company), then you are guilty of overutilization for selling for these uses and you will have to eventually "disgorge" three times (3X) these sales back to the government.  That's what happened to GSK when it had to pay $3 Billion.  Individual corporate officers had to defend themselves in criminal court. You should argue that you are saving them, the company and the investors of this painful process.  You can see all the Corporate Integrity Agreements for drugs and device companies here:  http://oig.hhs.gov/compliance/corporate-integrity-agreements/cia-documents.asp

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Andrea Chamblee RAC, FRAPS
Director
FDA
Rockville MD
United States
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Original Message:
Sent: 07-12-2012 14:20
From: Vicki Gail
Subject: Promotional Material Control as Labeling

Fellow Members,

I am sure at one time or another you have all encountered challenges with Management and QA/RA policies. My current "challenge" is the view from management that promotional material is not subject to regulatory oversight as labeling. How has anyone else overcome this challenge with labeling? (I have already cited FDA/ISO guidance and standards)  Thanks you.
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Vicki Gail
QA / RA Manager
Agoura Hills CA
United States
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