Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

A study director has proposed coating an innovator product to match the appearance of a placebo for the purposes of conducting a blinded study, rather than over-encapsulation.  Would this be considered mis-branding or are there other potential "security" concerns with doing this?  This is not a controlled substance.

I would not consider these coated to match tablets as misbranded, since 1) these should be labeled with a unique identifier tracing back to documentation of it all being blinded clinical material ('Content is either the defined active or placebo') and 2) it is not being commercially sold to the public.  Also, your clinical plan should have local, and either FDA notification or approval.  Yet beyond the usual chain of custody conformance, I hope someone else could chime in and address your security concerns.  I hope this helps.  All the best to you.

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Reuben Lidster
Regulatory Specialist
Bloomington IN
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Original Message:
Sent: 07-Feb-2017 08:49
From: Anonymous Member
Subject: Coating innovator tablet for blinded study

This message was posted by a user wishing to remain anonymous

A study director has proposed coating an innovator product to match the appearance of a placebo for the purposes of conducting a blinded study, rather than over-encapsulation.  Would this be considered mis-branding or are there other potential "security" concerns with doing this?  This is not a controlled substance.

This message was posted by a user wishing to remain anonymous

Interesting an I agree.  We have been asked in the past to make placebo tablets and emboss them so they are identical to the RLD.  We have stayed away from these projects, concerned that once the product leaves our custody, those tablets would be subject to black-market sales if the wrong people got their hands on them.  I am curious to the opinions of others on this board and if we are just too conservative. 
Original Message:
Sent: 08-Feb-2017 10:17
From: Reuben Lidster
Subject: Coating innovator tablet for blinded study

I would not consider these coated to match tablets as misbranded, since 1) these should be labeled with a unique identifier tracing back to documentation of it all being blinded clinical material ('Content is either the defined active or placebo') and 2) it is not being commercially sold to the public.  Also, your clinical plan should have local, and either FDA notification or approval.  Yet beyond the usual chain of custody conformance, I hope someone else could chime in and address your security concerns.  I hope this helps.  All the best to you.

------------------------------
Reuben Lidster
Regulatory Specialist
Bloomington IN
------------------------------

Original Message:
Sent: 07-Feb-2017 08:49
From: Anonymous Member
Subject: Coating innovator tablet for blinded study

This message was posted by a user wishing to remain anonymous

A study director has proposed coating an innovator product to match the appearance of a placebo for the purposes of conducting a blinded study, rather than over-encapsulation.  Would this be considered mis-branding or are there other potential "security" concerns with doing this?  This is not a controlled substance.

I am assuming you are planning a double-blind trial.  The developed tablet and control tablet must be
indistinguishable by appearance, taste, etc. before and during administration and throughout the trial.
Encapsulation is commonly used if the shape, size, or color of the tablet differ or if the tablets taste differently.
Some companies find it is easiest to encapsulate the tablets identically.

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Darlene O'Banion
Founder/Principal Consultant
Regulatory QS
San Jose, CA USA
RegulatoryQS@earthlink.net
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Original Message:
Sent: 13-Feb-2017 09:30
From: Anonymous Member
Subject: Coating innovator tablet for blinded study

This message was posted by a user wishing to remain anonymous

Interesting an I agree.  We have been asked in the past to make placebo tablets and emboss them so they are identical to the RLD.  We have stayed away from these projects, concerned that once the product leaves our custody, those tablets would be subject to black-market sales if the wrong people got their hands on them.  I am curious to the opinions of others on this board and if we are just too conservative. 
Original Message:
Sent: 08-Feb-2017 10:17
From: Reuben Lidster
Subject: Coating innovator tablet for blinded study

I would not consider these coated to match tablets as misbranded, since 1) these should be labeled with a unique identifier tracing back to documentation of it all being blinded clinical material ('Content is either the defined active or placebo') and 2) it is not being commercially sold to the public.  Also, your clinical plan should have local, and either FDA notification or approval.  Yet beyond the usual chain of custody conformance, I hope someone else could chime in and address your security concerns.  I hope this helps.  All the best to you.

------------------------------
Reuben Lidster
Regulatory Specialist
Bloomington IN
------------------------------

Original Message:
Sent: 07-Feb-2017 08:49
From: Anonymous Member
Subject: Coating innovator tablet for blinded study

This message was posted by a user wishing to remain anonymous

A study director has proposed coating an innovator product to match the appearance of a placebo for the purposes of conducting a blinded study, rather than over-encapsulation.  Would this be considered mis-branding or are there other potential "security" concerns with doing this?  This is not a controlled substance.