Regulatory Open Forum

Good Afternoon,

I am new to the promotional review process for prescription drugs.  I am also involved in creating a promotional review and approval system.  The regulations are vague with respect to when to submit the approved material to DDMAC.  The regulations say "to submit at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement...".  I am looking at the statement as saying we need to submit the new material at the time it is released.  Right now, we are submitting the material in an annual report to DDMAC. 

What is the correct way of submitting promotional material to DDMAC? 

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Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
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The regulations you have cited give the direction that the promotional materials (promotional labeling) must be submitted at the time of initial dissemination, and advertisements submitted at the time of publication.  Requiring that the 2253 submission occurrs on or before the date of release of materials ensures that you will be compliant.  For advertisements, there is usually a lead time required by the publisher (or tv or radio) to have final materials prior to the publication, however, requiring 2253 submission prior to release to the publisher again helps to ensure that you are compliant with the regualtions.


Mary Kay Rybicki
Principal Consultant
Naperville IL
United States
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Original Message:
Sent: 06-16-2011 14:38
From: Alison Trado
Subject: Promotional Material

Good Afternoon,

I am new to the promotional review process for prescription drugs.  I am also involved in creating a promotional review and approval system.  The regulations are vague with respect to when to submit the approved material to DDMAC.  The regulations say "to submit at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement...".  I am looking at the statement as saying we need to submit the new material at the time it is released.  Right now, we are submitting the material in an annual report to DDMAC. 

What is the correct way of submitting promotional material to DDMAC? 

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

Hi Allison,

You must submit any promotional labeling or advertising at or before the date of first use, using Form 2253.  The annual report is not the appropriate method for submission/notification regarding promotional materials.

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Cynthia Courtney
Director, Regulatory Compliance
Sunovion Pharmaceuticals Inc.
Marlborough MA
United States
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Original Message:
Sent: 06-16-2011 14:38
From: Alison Trado
Subject: Promotional Material

Good Afternoon,

I am new to the promotional review process for prescription drugs.  I am also involved in creating a promotional review and approval system.  The regulations are vague with respect to when to submit the approved material to DDMAC.  The regulations say "to submit at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement...".  I am looking at the statement as saying we need to submit the new material at the time it is released.  Right now, we are submitting the material in an annual report to DDMAC. 

What is the correct way of submitting promotional material to DDMAC? 

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

I haven't done DDMAC promo for a few years.  However, in my prior company, we always submitted the FDA Form 2253 date concurrent with (or just prior to) the first use of the material.  We defined "first use" as the date of a symposium or when material was available to the field.

-------------------------------------------
Julia Nelson RAC
Principal Regulatory Affairs Specialist
Medtronic Cardiovascular
Moundsview MN
United States
-------------------------------------------






Original Message:
Sent: 06-16-2011 14:38
From: Alison Trado
Subject: Promotional Material

Good Afternoon,

I am new to the promotional review process for prescription drugs.  I am also involved in creating a promotional review and approval system.  The regulations are vague with respect to when to submit the approved material to DDMAC.  The regulations say "to submit at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement...".  I am looking at the statement as saying we need to submit the new material at the time it is released.  Right now, we are submitting the material in an annual report to DDMAC. 

What is the correct way of submitting promotional material to DDMAC? 

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

Thank you for your replies.  I am finalizing an SOP with the directions as stated by the regulations and you all!  I really appreciate it! 


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






Original Message:
Sent: 06-17-2011 14:13
From: Julia Nelson
Subject: Promotional Material

I haven't done DDMAC promo for a few years.  However, in my prior company, we always submitted the FDA Form 2253 date concurrent with (or just prior to) the first use of the material.  We defined "first use" as the date of a symposium or when material was available to the field.

-------------------------------------------
Julia Nelson RAC
Principal Regulatory Affairs Specialist
Medtronic Cardiovascular
Moundsview MN
United States
-------------------------------------------