Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective). 

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks, 
A.Non

First, your question is a little confusing in that you mention NME and BLA referring to the same process?  You would not file a BLA for an NME since the NME does apply to biologics/biotech products.  I do have experience with FDA and approval of a NME without an agreed upon trade name - it is not required, but you would not get a good label for marketing purposes as the label would provide only the INN/USAN.

------------------------------
Glen Park
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non

This message was posted by a user wishing to remain anonymous

Thanks Glen, you did answer part of my question. And apologies for the confusing statement, it was meant to read as NME/NCE/biologics as part of NDA/BLA (essentially a new product, not a generic version). I was wondering if you had any insight on the European process.
thanks!
Original Message:
Sent: 21-Dec-2018 11:33
From: Glen Park
Subject: Brand name requirement-US / EU

First, your question is a little confusing in that you mention NME and BLA referring to the same process?  You would not file a BLA for an NME since the NME does apply to biologics/biotech products.  I do have experience with FDA and approval of a NME without an agreed upon trade name - it is not required, but you would not get a good label for marketing purposes as the label would provide only the INN/USAN.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non

No, I don't have EU experience.

------------------------------
Glen Park
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 21-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

Thanks Glen, you did answer part of my question. And apologies for the confusing statement, it was meant to read as NME/NCE/biologics as part of NDA/BLA (essentially a new product, not a generic version). I was wondering if you had any insight on the European process.
thanks!
Original Message:
Sent: 21-Dec-2018 11:33
From: Glen Park
Subject: Brand name requirement-US / EU

First, your question is a little confusing in that you mention NME and BLA referring to the same process?  You would not file a BLA for an NME since the NME does apply to biologics/biotech products.  I do have experience with FDA and approval of a NME without an agreed upon trade name - it is not required, but you would not get a good label for marketing purposes as the label would provide only the INN/USAN.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non

This message was posted by a user wishing to remain anonymous

In both regions, you can submit your proposed brand names in advance of your MAA or BLA submissions to determine if there any issues before including in your marketing applications.  Most companies want to have a single brand name that is acceptable globally.  A strategy we use at my company is we submit the proposed names to EMA first and once we get the reply we submit to FDA during the IND phase.  Then, that single brand name is submitted in all of the global marketing applications.  Here is a link to the FDA guidance regarding proprietary name submissions:  https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075068.pdf

For your BLA, remember to also provide your list of proposed four-letter suffixes that will be tacked on to your nonproprietary name.  https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM459987.pdf
Original Message:
Sent: 21-Dec-2018 11:33
From: Glen Park
Subject: Brand name requirement-US / EU

First, your question is a little confusing in that you mention NME and BLA referring to the same process?  You would not file a BLA for an NME since the NME does apply to biologics/biotech products.  I do have experience with FDA and approval of a NME without an agreed upon trade name - it is not required, but you would not get a good label for marketing purposes as the label would provide only the INN/USAN.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non

​For FDA approval of NME/ NCE, I would be curious to know whether Glen's experience was many years ago since I do not believe that FDA would currently approve a marketing application without the review and approval of the Proprietary Name.  The reason for this is because the review and approval of a drug /biologic relates to an overall assessment of safety.  As you may know in the US, a company needs to submit a request for assignment of a proprietary name.  Applicants generally contract an independent assessment of the name and its potential for misuse, confusion with other drug names and any suggestions for uses beyond which the clinical data has substantiated for being safe and effective. However, FDA conducts a similar evaluation and make the final decision on selection.  I don't think FDA would be favorable in reviewing a marketing application when an applicant is not planning to commercial a product upon FDA approval.  I do not know the detailed regulatory requirements on this issue outside the USA.

------------------------------
Michael Trapani
Senior Consultant
Monroe Township NJ
United States
------------------------------

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non

The product was approved in 2009. TRADENAME was on the approved label as the ... well, trade name.

------------------------------
Glen Park
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 22-Dec-2018 10:15
From: Michael Trapani
Subject: Brand name requirement-US / EU

​For FDA approval of NME/ NCE, I would be curious to know whether Glen's experience was many years ago since I do not believe that FDA would currently approve a marketing application without the review and approval of the Proprietary Name.  The reason for this is because the review and approval of a drug /biologic relates to an overall assessment of safety.  As you may know in the US, a company needs to submit a request for assignment of a proprietary name.  Applicants generally contract an independent assessment of the name and its potential for misuse, confusion with other drug names and any suggestions for uses beyond which the clinical data has substantiated for being safe and effective. However, FDA conducts a similar evaluation and make the final decision on selection.  I don't think FDA would be favorable in reviewing a marketing application when an applicant is not planning to commercial a product upon FDA approval.  I do not know the detailed regulatory requirements on this issue outside the USA.

------------------------------
Michael Trapani
Senior Consultant
Monroe Township NJ
United States

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non

The only other comment I'd like to add is that although the NME/NCE/NBE (NDA/BLA) was approved without a brand name, the FDA would probably not allow to market it until a trade name is also approved post-approval via a supplement where the trade name would undergo review process.

------------------------------
GRSAOnline
------------------------------

Original Message:
Sent: 22-Dec-2018 12:35
From: Glen Park
Subject: Brand name requirement-US / EU

The product was approved in 2009. TRADENAME was on the approved label as the ... well, trade name.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 22-Dec-2018 10:15
From: Michael Trapani
Subject: Brand name requirement-US / EU

​For FDA approval of NME/ NCE, I would be curious to know whether Glen's experience was many years ago since I do not believe that FDA would currently approve a marketing application without the review and approval of the Proprietary Name.  The reason for this is because the review and approval of a drug /biologic relates to an overall assessment of safety.  As you may know in the US, a company needs to submit a request for assignment of a proprietary name.  Applicants generally contract an independent assessment of the name and its potential for misuse, confusion with other drug names and any suggestions for uses beyond which the clinical data has substantiated for being safe and effective. However, FDA conducts a similar evaluation and make the final decision on selection.  I don't think FDA would be favorable in reviewing a marketing application when an applicant is not planning to commercial a product upon FDA approval.  I do not know the detailed regulatory requirements on this issue outside the USA.

------------------------------
Michael Trapani
Senior Consultant
Monroe Township NJ
United States

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non

I would like my colleagues to provide a citation that indicates that FDA would not approve marketing of a product that does not have a BRANDNAME.  Although, it was in 2009, as noted above, the approval letter for the product stated:

PROPRIETARY NAME
If you intend to have a proprietary name for this product we recommend that you submit a request for a proposed proprietary name review. (See the draft Guidance for Industry, Complete Submission for the Evaluation of Proprietary Names, http://www.fda.gov/cder/guidance/7935dft.pdf and "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 through 2012."

No where else in the cover letter was there any indication that the product could not be marketed without a Proprietary Name. What I don't understand is how a generic product could be marketed without a brand name, but an NCE cannot?  Please help me understand.

------------------------------
Glen Park
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 23-Dec-2018 11:54
From: Narayan Rao
Subject: Brand name requirement-US / EU

The only other comment I'd like to add is that although the NME/NCE/NBE (NDA/BLA) was approved without a brand name, the FDA would probably not allow to market it until a trade name is also approved post-approval via a supplement where the trade name would undergo review process.

------------------------------
GRSAOnline

Original Message:
Sent: 22-Dec-2018 12:35
From: Glen Park
Subject: Brand name requirement-US / EU

The product was approved in 2009. TRADENAME was on the approved label as the ... well, trade name.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 22-Dec-2018 10:15
From: Michael Trapani
Subject: Brand name requirement-US / EU

​For FDA approval of NME/ NCE, I would be curious to know whether Glen's experience was many years ago since I do not believe that FDA would currently approve a marketing application without the review and approval of the Proprietary Name.  The reason for this is because the review and approval of a drug /biologic relates to an overall assessment of safety.  As you may know in the US, a company needs to submit a request for assignment of a proprietary name.  Applicants generally contract an independent assessment of the name and its potential for misuse, confusion with other drug names and any suggestions for uses beyond which the clinical data has substantiated for being safe and effective. However, FDA conducts a similar evaluation and make the final decision on selection.  I don't think FDA would be favorable in reviewing a marketing application when an applicant is not planning to commercial a product upon FDA approval.  I do not know the detailed regulatory requirements on this issue outside the USA.

------------------------------
Michael Trapani
Senior Consultant
Monroe Township NJ
United States

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non

There is no requirement to have a proprietary name (Brandname) for a product for it to be marketed.  This has NEVER been a requirement from FDA.  As correctly pointed out, generic drugs are typically marketed without a brandname.  Also, some biologics are marketed without a brandname (i.e., Factor VIII injection).

Because of concerns and issues with name confusion and medication errors, in 2007, PDUFA IV authorized FDA to include the review and approval of a product's brandname as part of the approval process.  This was to try to reduce the number of medication errors due to name confusion and mis-prescribing.  So now, IF you want to use a brandname to market your product, the name must be approved by FDA prior to its use.  There is a 2016 Guidance on Evaluation of a Proprietary Name that addresses what is required in order for FDA to review and (hopefully) approve a brandname for a product.  This guidance applies to drugs and biologics, including INDs, BLAs, NDAs and ANDAs.  This applies to the initial selection of a brandname as well as any proposed name change.

It would be highly unusual for a company to propose to begin to market a product with a brandname.  Why??  Because this allows the company to establish a marketing and promotional campaign for the product, to establish name recognition, company connection, etc., all enhancements to successful marketing your product.  Your marketing/sales colleagues would be outraged if they could not have a brandname to help build this name-company identity.

so, if you want to have a brandname, it must be reviewed and approved by FDA, but you can market your product without a brandname if you choose.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States
------------------------------

Original Message:
Sent: 24-Dec-2018 08:24
From: Glen Park
Subject: Brand name requirement-US / EU

I would like my colleagues to provide a citation that indicates that FDA would not approve marketing of a product that does not have a BRANDNAME.  Although, it was in 2009, as noted above, the approval letter for the product stated:

PROPRIETARY NAME
If you intend to have a proprietary name for this product we recommend that you submit a request for a proposed proprietary name review. (See the draft Guidance for Industry, Complete Submission for the Evaluation of Proprietary Names, http://www.fda.gov/cder/guidance/7935dft.pdf and "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 through 2012."

No where else in the cover letter was there any indication that the product could not be marketed without a Proprietary Name. What I don't understand is how a generic product could be marketed without a brand name, but an NCE cannot?  Please help me understand.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 23-Dec-2018 11:54
From: Narayan Rao
Subject: Brand name requirement-US / EU

The only other comment I'd like to add is that although the NME/NCE/NBE (NDA/BLA) was approved without a brand name, the FDA would probably not allow to market it until a trade name is also approved post-approval via a supplement where the trade name would undergo review process.

------------------------------
GRSAOnline

Original Message:
Sent: 22-Dec-2018 12:35
From: Glen Park
Subject: Brand name requirement-US / EU

The product was approved in 2009. TRADENAME was on the approved label as the ... well, trade name.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 22-Dec-2018 10:15
From: Michael Trapani
Subject: Brand name requirement-US / EU

​For FDA approval of NME/ NCE, I would be curious to know whether Glen's experience was many years ago since I do not believe that FDA would currently approve a marketing application without the review and approval of the Proprietary Name.  The reason for this is because the review and approval of a drug /biologic relates to an overall assessment of safety.  As you may know in the US, a company needs to submit a request for assignment of a proprietary name.  Applicants generally contract an independent assessment of the name and its potential for misuse, confusion with other drug names and any suggestions for uses beyond which the clinical data has substantiated for being safe and effective. However, FDA conducts a similar evaluation and make the final decision on selection.  I don't think FDA would be favorable in reviewing a marketing application when an applicant is not planning to commercial a product upon FDA approval.  I do not know the detailed regulatory requirements on this issue outside the USA.

------------------------------
Michael Trapani
Senior Consultant
Monroe Township NJ
United States

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non

This message was posted by a user wishing to remain anonymous

I am not so sure about your response! For generic drugs, the drug is well known after having marketed as an innovative branded product for almost 20 years with both clinical data and real life marketed data Versus a newly approved innovative NCE without real life marketing history and the fact that the proposed brand name requires to be reviewed and approved per PDUFA regulations, can be marketed without a brand name??? I think that one may not have a direct CFR citation but indirectly PDUFA regulations may imply that one cannot market a NCE without a brand name.
Original Message:
Sent: 25-Dec-2018 10:28
From: Michael Hamrell
Subject: Brand name requirement-US / EU

There is no requirement to have a proprietary name (Brandname) for a product for it to be marketed.  This has NEVER been a requirement from FDA.  As correctly pointed out, generic drugs are typically marketed without a brandname.  Also, some biologics are marketed without a brandname (i.e., Factor VIII injection).

Because of concerns and issues with name confusion and medication errors, in 2007, PDUFA IV authorized FDA to include the review and approval of a product's brandname as part of the approval process.  This was to try to reduce the number of medication errors due to name confusion and mis-prescribing.  So now, IF you want to use a brandname to market your product, the name must be approved by FDA prior to its use.  There is a 2016 Guidance on Evaluation of a Proprietary Name that addresses what is required in order for FDA to review and (hopefully) approve a brandname for a product.  This guidance applies to drugs and biologics, including INDs, BLAs, NDAs and ANDAs.  This applies to the initial selection of a brandname as well as any proposed name change.

It would be highly unusual for a company to propose to begin to market a product with a brandname.  Why??  Because this allows the company to establish a marketing and promotional campaign for the product, to establish name recognition, company connection, etc., all enhancements to successful marketing your product.  Your marketing/sales colleagues would be outraged if they could not have a brandname to help build this name-company identity.

so, if you want to have a brandname, it must be reviewed and approved by FDA, but you can market your product without a brandname if you choose.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 24-Dec-2018 08:24
From: Glen Park
Subject: Brand name requirement-US / EU

I would like my colleagues to provide a citation that indicates that FDA would not approve marketing of a product that does not have a BRANDNAME.  Although, it was in 2009, as noted above, the approval letter for the product stated:

PROPRIETARY NAME
If you intend to have a proprietary name for this product we recommend that you submit a request for a proposed proprietary name review. (See the draft Guidance for Industry, Complete Submission for the Evaluation of Proprietary Names, http://www.fda.gov/cder/guidance/7935dft.pdf and "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 through 2012."

No where else in the cover letter was there any indication that the product could not be marketed without a Proprietary Name. What I don't understand is how a generic product could be marketed without a brand name, but an NCE cannot?  Please help me understand.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 23-Dec-2018 11:54
From: Narayan Rao
Subject: Brand name requirement-US / EU

The only other comment I'd like to add is that although the NME/NCE/NBE (NDA/BLA) was approved without a brand name, the FDA would probably not allow to market it until a trade name is also approved post-approval via a supplement where the trade name would undergo review process.

------------------------------
GRSAOnline

Original Message:
Sent: 22-Dec-2018 12:35
From: Glen Park
Subject: Brand name requirement-US / EU

The product was approved in 2009. TRADENAME was on the approved label as the ... well, trade name.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 22-Dec-2018 10:15
From: Michael Trapani
Subject: Brand name requirement-US / EU

​For FDA approval of NME/ NCE, I would be curious to know whether Glen's experience was many years ago since I do not believe that FDA would currently approve a marketing application without the review and approval of the Proprietary Name.  The reason for this is because the review and approval of a drug /biologic relates to an overall assessment of safety.  As you may know in the US, a company needs to submit a request for assignment of a proprietary name.  Applicants generally contract an independent assessment of the name and its potential for misuse, confusion with other drug names and any suggestions for uses beyond which the clinical data has substantiated for being safe and effective. However, FDA conducts a similar evaluation and make the final decision on selection.  I don't think FDA would be favorable in reviewing a marketing application when an applicant is not planning to commercial a product upon FDA approval.  I do not know the detailed regulatory requirements on this issue outside the USA.

------------------------------
Michael Trapani
Senior Consultant
Monroe Township NJ
United States

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non

Michael:  I agree with what you wrote but where you said: "It would be highly unusual for a company to propose to begin to market a product with a brand name" I think you meant to actually say: "It would be highly unusual for a company NOT to propose to begin to market a product with a brand name."  
Chris

------------------------------
Christopher Smith, CQE, RAC
Coastal Pharmaceutical Consultants, Inc.
7950 Old River Road
Burgaw, NC 28425, USA
910.259.8877 (land)
910.789.1232 (mobile)
chrissmith@coastalpharmaconsultants.com
------------------------------

Original Message:
Sent: 25-Dec-2018 18:12
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I am not so sure about your response! For generic drugs, the drug is well known after having marketed as an innovative branded product for almost 20 years with both clinical data and real life marketed data Versus a newly approved innovative NCE without real life marketing history and the fact that the proposed brand name requires to be reviewed and approved per PDUFA regulations, can be marketed without a brand name??? I think that one may not have a direct CFR citation but indirectly PDUFA regulations may imply that one cannot market a NCE without a brand name.
Original Message:
Sent: 25-Dec-2018 10:28
From: Michael Hamrell
Subject: Brand name requirement-US / EU

There is no requirement to have a proprietary name (Brandname) for a product for it to be marketed.  This has NEVER been a requirement from FDA.  As correctly pointed out, generic drugs are typically marketed without a brandname.  Also, some biologics are marketed without a brandname (i.e., Factor VIII injection).

Because of concerns and issues with name confusion and medication errors, in 2007, PDUFA IV authorized FDA to include the review and approval of a product's brandname as part of the approval process.  This was to try to reduce the number of medication errors due to name confusion and mis-prescribing.  So now, IF you want to use a brandname to market your product, the name must be approved by FDA prior to its use.  There is a 2016 Guidance on Evaluation of a Proprietary Name that addresses what is required in order for FDA to review and (hopefully) approve a brandname for a product.  This guidance applies to drugs and biologics, including INDs, BLAs, NDAs and ANDAs.  This applies to the initial selection of a brandname as well as any proposed name change.

It would be highly unusual for a company to propose to begin to market a product with a brandname.  Why??  Because this allows the company to establish a marketing and promotional campaign for the product, to establish name recognition, company connection, etc., all enhancements to successful marketing your product.  Your marketing/sales colleagues would be outraged if they could not have a brandname to help build this name-company identity.

so, if you want to have a brandname, it must be reviewed and approved by FDA, but you can market your product without a brandname if you choose.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 24-Dec-2018 08:24
From: Glen Park
Subject: Brand name requirement-US / EU

I would like my colleagues to provide a citation that indicates that FDA would not approve marketing of a product that does not have a BRANDNAME.  Although, it was in 2009, as noted above, the approval letter for the product stated:

PROPRIETARY NAME
If you intend to have a proprietary name for this product we recommend that you submit a request for a proposed proprietary name review. (See the draft Guidance for Industry, Complete Submission for the Evaluation of Proprietary Names, http://www.fda.gov/cder/guidance/7935dft.pdf and "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 through 2012."

No where else in the cover letter was there any indication that the product could not be marketed without a Proprietary Name. What I don't understand is how a generic product could be marketed without a brand name, but an NCE cannot?  Please help me understand.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 23-Dec-2018 11:54
From: Narayan Rao
Subject: Brand name requirement-US / EU

The only other comment I'd like to add is that although the NME/NCE/NBE (NDA/BLA) was approved without a brand name, the FDA would probably not allow to market it until a trade name is also approved post-approval via a supplement where the trade name would undergo review process.

------------------------------
GRSAOnline

Original Message:
Sent: 22-Dec-2018 12:35
From: Glen Park
Subject: Brand name requirement-US / EU

The product was approved in 2009. TRADENAME was on the approved label as the ... well, trade name.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 22-Dec-2018 10:15
From: Michael Trapani
Subject: Brand name requirement-US / EU

​For FDA approval of NME/ NCE, I would be curious to know whether Glen's experience was many years ago since I do not believe that FDA would currently approve a marketing application without the review and approval of the Proprietary Name.  The reason for this is because the review and approval of a drug /biologic relates to an overall assessment of safety.  As you may know in the US, a company needs to submit a request for assignment of a proprietary name.  Applicants generally contract an independent assessment of the name and its potential for misuse, confusion with other drug names and any suggestions for uses beyond which the clinical data has substantiated for being safe and effective. However, FDA conducts a similar evaluation and make the final decision on selection.  I don't think FDA would be favorable in reviewing a marketing application when an applicant is not planning to commercial a product upon FDA approval.  I do not know the detailed regulatory requirements on this issue outside the USA.

------------------------------
Michael Trapani
Senior Consultant
Monroe Township NJ
United States

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non

Chris:  yes.  thanks for correcting the typo.  It would be very unusual for a company to NOT have a brandname to market a drug.

However, as I stated before, THERE IS NO REQUIREMENT TO HAVE A Brandname.  It does not matter if it is a NCE or a generic version. 

Before 2007, name choices weren't even formally reviewed by FDA.  This led to several examples of name confusions and mis-prescribing and was considered a safety issue.  The 2007 law now requires that IF you want to use a brandname, it must be approved by FDA prior to use to minimize the likelihood of prescribing problems.  However, there is no requirement to have a brandname.  Nothing in PDUFA makes this a requirement, only a requirement that you choice must be approved if you want to have a brandname.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States
------------------------------

Original Message:
Sent: 27-Dec-2018 09:09
From: Christopher Smith
Subject: Brand name requirement-US / EU

Michael:  I agree with what you wrote but where you said: "It would be highly unusual for a company to propose to begin to market a product with a brand name" I think you meant to actually say: "It would be highly unusual for a company NOT to propose to begin to market a product with a brand name."
Chris

------------------------------
Christopher Smith, CQE, RAC
Coastal Pharmaceutical Consultants, Inc.
7950 Old River Road
Burgaw, NC 28425, USA
910.259.8877 (land)
910.789.1232 (mobile)
chrissmith@coastalpharmaconsultants.com

Original Message:
Sent: 25-Dec-2018 18:12
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I am not so sure about your response! For generic drugs, the drug is well known after having marketed as an innovative branded product for almost 20 years with both clinical data and real life marketed data Versus a newly approved innovative NCE without real life marketing history and the fact that the proposed brand name requires to be reviewed and approved per PDUFA regulations, can be marketed without a brand name??? I think that one may not have a direct CFR citation but indirectly PDUFA regulations may imply that one cannot market a NCE without a brand name.
Original Message:
Sent: 25-Dec-2018 10:28
From: Michael Hamrell
Subject: Brand name requirement-US / EU

There is no requirement to have a proprietary name (Brandname) for a product for it to be marketed.  This has NEVER been a requirement from FDA.  As correctly pointed out, generic drugs are typically marketed without a brandname.  Also, some biologics are marketed without a brandname (i.e., Factor VIII injection).

Because of concerns and issues with name confusion and medication errors, in 2007, PDUFA IV authorized FDA to include the review and approval of a product's brandname as part of the approval process.  This was to try to reduce the number of medication errors due to name confusion and mis-prescribing.  So now, IF you want to use a brandname to market your product, the name must be approved by FDA prior to its use.  There is a 2016 Guidance on Evaluation of a Proprietary Name that addresses what is required in order for FDA to review and (hopefully) approve a brandname for a product.  This guidance applies to drugs and biologics, including INDs, BLAs, NDAs and ANDAs.  This applies to the initial selection of a brandname as well as any proposed name change.

It would be highly unusual for a company to propose to begin to market a product with a brandname.  Why??  Because this allows the company to establish a marketing and promotional campaign for the product, to establish name recognition, company connection, etc., all enhancements to successful marketing your product.  Your marketing/sales colleagues would be outraged if they could not have a brandname to help build this name-company identity.

so, if you want to have a brandname, it must be reviewed and approved by FDA, but you can market your product without a brandname if you choose.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 24-Dec-2018 08:24
From: Glen Park
Subject: Brand name requirement-US / EU

I would like my colleagues to provide a citation that indicates that FDA would not approve marketing of a product that does not have a BRANDNAME.  Although, it was in 2009, as noted above, the approval letter for the product stated:

PROPRIETARY NAME
If you intend to have a proprietary name for this product we recommend that you submit a request for a proposed proprietary name review. (See the draft Guidance for Industry, Complete Submission for the Evaluation of Proprietary Names, http://www.fda.gov/cder/guidance/7935dft.pdf and "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 through 2012."

No where else in the cover letter was there any indication that the product could not be marketed without a Proprietary Name. What I don't understand is how a generic product could be marketed without a brand name, but an NCE cannot?  Please help me understand.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 23-Dec-2018 11:54
From: Narayan Rao
Subject: Brand name requirement-US / EU

The only other comment I'd like to add is that although the NME/NCE/NBE (NDA/BLA) was approved without a brand name, the FDA would probably not allow to market it until a trade name is also approved post-approval via a supplement where the trade name would undergo review process.

------------------------------
GRSAOnline

Original Message:
Sent: 22-Dec-2018 12:35
From: Glen Park
Subject: Brand name requirement-US / EU

The product was approved in 2009. TRADENAME was on the approved label as the ... well, trade name.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 22-Dec-2018 10:15
From: Michael Trapani
Subject: Brand name requirement-US / EU

​For FDA approval of NME/ NCE, I would be curious to know whether Glen's experience was many years ago since I do not believe that FDA would currently approve a marketing application without the review and approval of the Proprietary Name.  The reason for this is because the review and approval of a drug /biologic relates to an overall assessment of safety.  As you may know in the US, a company needs to submit a request for assignment of a proprietary name.  Applicants generally contract an independent assessment of the name and its potential for misuse, confusion with other drug names and any suggestions for uses beyond which the clinical data has substantiated for being safe and effective. However, FDA conducts a similar evaluation and make the final decision on selection.  I don't think FDA would be favorable in reviewing a marketing application when an applicant is not planning to commercial a product upon FDA approval.  I do not know the detailed regulatory requirements on this issue outside the USA.

------------------------------
Michael Trapani
Senior Consultant
Monroe Township NJ
United States

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non

​Thanks to all.  This has been a very good discussions regarding whether a BRAND NAME for a NCE or NME is required for approval.  It reminds me of the age old expression that there is science and then there is regulatory science.  Suffice to say, in reality, a Proprietary Name will be proposed and FDA will to approve it prior to commercialization.  After all the costs of development and user fees, I can't see how any entity would pursue approval and try to commercialize such a drug/biologic without a Proprietary name.

------------------------------
Michael Trapani
Senior Consultant
Monroe Township NJ
United States
------------------------------

Original Message:
Sent: 27-Dec-2018 09:51
From: Michael Hamrell
Subject: Brand name requirement-US / EU

Chris:  yes.  thanks for correcting the typo.  It would be very unusual for a company to NOT have a brandname to market a drug.

However, as I stated before, THERE IS NO REQUIREMENT TO HAVE A Brandname.  It does not matter if it is a NCE or a generic version.

Before 2007, name choices weren't even formally reviewed by FDA.  This led to several examples of name confusions and mis-prescribing and was considered a safety issue.  The 2007 law now requires that IF you want to use a brandname, it must be approved by FDA prior to use to minimize the likelihood of prescribing problems.  However, there is no requirement to have a brandname.  Nothing in PDUFA makes this a requirement, only a requirement that you choice must be approved if you want to have a brandname.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 27-Dec-2018 09:09
From: Christopher Smith
Subject: Brand name requirement-US / EU

Michael:  I agree with what you wrote but where you said: "It would be highly unusual for a company to propose to begin to market a product with a brand name" I think you meant to actually say: "It would be highly unusual for a company NOT to propose to begin to market a product with a brand name."
Chris

------------------------------
Christopher Smith, CQE, RAC
Coastal Pharmaceutical Consultants, Inc.
7950 Old River Road
Burgaw, NC 28425, USA
910.259.8877 (land)
910.789.1232 (mobile)
chrissmith@coastalpharmaconsultants.com

Original Message:
Sent: 25-Dec-2018 18:12
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I am not so sure about your response! For generic drugs, the drug is well known after having marketed as an innovative branded product for almost 20 years with both clinical data and real life marketed data Versus a newly approved innovative NCE without real life marketing history and the fact that the proposed brand name requires to be reviewed and approved per PDUFA regulations, can be marketed without a brand name??? I think that one may not have a direct CFR citation but indirectly PDUFA regulations may imply that one cannot market a NCE without a brand name.
Original Message:
Sent: 25-Dec-2018 10:28
From: Michael Hamrell
Subject: Brand name requirement-US / EU

There is no requirement to have a proprietary name (Brandname) for a product for it to be marketed.  This has NEVER been a requirement from FDA.  As correctly pointed out, generic drugs are typically marketed without a brandname.  Also, some biologics are marketed without a brandname (i.e., Factor VIII injection).

Because of concerns and issues with name confusion and medication errors, in 2007, PDUFA IV authorized FDA to include the review and approval of a product's brandname as part of the approval process.  This was to try to reduce the number of medication errors due to name confusion and mis-prescribing.  So now, IF you want to use a brandname to market your product, the name must be approved by FDA prior to its use.  There is a 2016 Guidance on Evaluation of a Proprietary Name that addresses what is required in order for FDA to review and (hopefully) approve a brandname for a product.  This guidance applies to drugs and biologics, including INDs, BLAs, NDAs and ANDAs.  This applies to the initial selection of a brandname as well as any proposed name change.

It would be highly unusual for a company to propose to begin to market a product with a brandname.  Why??  Because this allows the company to establish a marketing and promotional campaign for the product, to establish name recognition, company connection, etc., all enhancements to successful marketing your product.  Your marketing/sales colleagues would be outraged if they could not have a brandname to help build this name-company identity.

so, if you want to have a brandname, it must be reviewed and approved by FDA, but you can market your product without a brandname if you choose.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 24-Dec-2018 08:24
From: Glen Park
Subject: Brand name requirement-US / EU

I would like my colleagues to provide a citation that indicates that FDA would not approve marketing of a product that does not have a BRANDNAME.  Although, it was in 2009, as noted above, the approval letter for the product stated:

PROPRIETARY NAME
If you intend to have a proprietary name for this product we recommend that you submit a request for a proposed proprietary name review. (See the draft Guidance for Industry, Complete Submission for the Evaluation of Proprietary Names, http://www.fda.gov/cder/guidance/7935dft.pdf and "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 through 2012."

No where else in the cover letter was there any indication that the product could not be marketed without a Proprietary Name. What I don't understand is how a generic product could be marketed without a brand name, but an NCE cannot?  Please help me understand.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 23-Dec-2018 11:54
From: Narayan Rao
Subject: Brand name requirement-US / EU

The only other comment I'd like to add is that although the NME/NCE/NBE (NDA/BLA) was approved without a brand name, the FDA would probably not allow to market it until a trade name is also approved post-approval via a supplement where the trade name would undergo review process.

------------------------------
GRSAOnline

Original Message:
Sent: 22-Dec-2018 12:35
From: Glen Park
Subject: Brand name requirement-US / EU

The product was approved in 2009. TRADENAME was on the approved label as the ... well, trade name.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 22-Dec-2018 10:15
From: Michael Trapani
Subject: Brand name requirement-US / EU

​For FDA approval of NME/ NCE, I would be curious to know whether Glen's experience was many years ago since I do not believe that FDA would currently approve a marketing application without the review and approval of the Proprietary Name.  The reason for this is because the review and approval of a drug /biologic relates to an overall assessment of safety.  As you may know in the US, a company needs to submit a request for assignment of a proprietary name.  Applicants generally contract an independent assessment of the name and its potential for misuse, confusion with other drug names and any suggestions for uses beyond which the clinical data has substantiated for being safe and effective. However, FDA conducts a similar evaluation and make the final decision on selection.  I don't think FDA would be favorable in reviewing a marketing application when an applicant is not planning to commercial a product upon FDA approval.  I do not know the detailed regulatory requirements on this issue outside the USA.

------------------------------
Michael Trapani
Senior Consultant
Monroe Township NJ
United States

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non

While I think this question has been adequately answered, I think there remains some confusion. The original question was whether a marketing application required inclusion of a brand or proprietary name, and whether the product could be approved with an internal code/name, with a qualification that the question was a regulatory question and NOT from a business/commercialization perspective.  The answer to the regulatory question is that there is NO requirement for a proprietary name to be included in the marketing application nor is there a regulatory requirement for a approval of a proprietary name for FDA to approve the application. I cited one precedent of a product approved post PDUFA IV to support this conclusion.

Colleagues who have questioned whether this conclusion is true are, I think, looking at the question from a commercial perspective. There is no question that there is a commercial need to establish a brand that is unique to the applicant. PDUFA IV and the subsequent guidance lay out the process for approval of a product with a proposed proprietary name, including writing a guidance on what constituted a "complete application" when a proprietary name is proposed.

It is important for regulatory professionals to distinguish between what the laws and regulations actually require and what may be in the best interest of a company that intends to market a commercially viable product. Otherwise, we cannot always provide the best advice to our industry.

------------------------------
Glen Park
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non

This message was posted by a user wishing to remain anonymous

Unless someone furnishes an NCE or NBE which was or is being currently marketed without a brand name as an example, this regulatory issue would remain unanswered. Just imagine a physician writing only a chemical/biological name for an indication as a prescription with no prior history? One cannot tell whether it is a NCE which was newly approved and requires a careful review versus a generic drug which is not a NCE!!! I think that this would create a safety issue and confusion.
Original Message:
Sent: 27-Dec-2018 10:02
From: Glen Park
Subject: Brand name requirement-US / EU

While I think this question has been adequately answered, I think there remains some confusion. The original question was whether a marketing application required inclusion of a brand or proprietary name, and whether the product could be approved with an internal code/name, with a qualification that the question was a regulatory question and NOT from a business/commercialization perspective.  The answer to the regulatory question is that there is NO requirement for a proprietary name to be included in the marketing application nor is there a regulatory requirement for a approval of a proprietary name for FDA to approve the application. I cited one precedent of a product approved post PDUFA IV to support this conclusion.

Colleagues who have questioned whether this conclusion is true are, I think, looking at the question from a commercial perspective. There is no question that there is a commercial need to establish a brand that is unique to the applicant. PDUFA IV and the subsequent guidance lay out the process for approval of a product with a proposed proprietary name, including writing a guidance on what constituted a "complete application" when a proprietary name is proposed.

It is important for regulatory professionals to distinguish between what the laws and regulations actually require and what may be in the best interest of a company that intends to market a commercially viable product. Otherwise, we cannot always provide the best advice to our industry.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non

As I and others have noted, it would be highly unusual for a company to attempt to commercialize a NCE/NME without a proprietary name. The example I provided that was approved in 2009 (benzyl alcohol for treatment of head lice) was approved with the posted label listing the brand name as BRANDNAME and a subsequent supplement implemented the proprietary name as ULESFIA. There was no prohibition against the manufacturer marketing the product as BRANDNAME indicated in the approval letter. 

Maybe more to the point is that raxibacumab was approved in 2012 as an original BLA for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. The labeling does not have a "proprietary" name per se.

These examples provide clear evidence that FDA does not require a proprietary name to approve a medical product or to make it available for sale and distribution.

------------------------------
Glen Park
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 27-Dec-2018 10:17
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

Unless someone furnishes an NCE or NBE which was or is being currently marketed without a brand name as an example, this regulatory issue would remain unanswered. Just imagine a physician writing only a chemical/biological name for an indication as a prescription with no prior history? One cannot tell whether it is a NCE which was newly approved and requires a careful review versus a generic drug which is not a NCE!!! I think that this would create a safety issue and confusion.
Original Message:
Sent: 27-Dec-2018 10:02
From: Glen Park
Subject: Brand name requirement-US / EU

While I think this question has been adequately answered, I think there remains some confusion. The original question was whether a marketing application required inclusion of a brand or proprietary name, and whether the product could be approved with an internal code/name, with a qualification that the question was a regulatory question and NOT from a business/commercialization perspective.  The answer to the regulatory question is that there is NO requirement for a proprietary name to be included in the marketing application nor is there a regulatory requirement for a approval of a proprietary name for FDA to approve the application. I cited one precedent of a product approved post PDUFA IV to support this conclusion.

Colleagues who have questioned whether this conclusion is true are, I think, looking at the question from a commercial perspective. There is no question that there is a commercial need to establish a brand that is unique to the applicant. PDUFA IV and the subsequent guidance lay out the process for approval of a product with a proposed proprietary name, including writing a guidance on what constituted a "complete application" when a proprietary name is proposed.

It is important for regulatory professionals to distinguish between what the laws and regulations actually require and what may be in the best interest of a company that intends to market a commercially viable product. Otherwise, we cannot always provide the best advice to our industry.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non

This message was posted by a user wishing to remain anonymous

Nice topic and interesting discussions!
However, as a regulatory professional, I felt obligated to provide a few points of clarifications or facts or whatever you may wish to consider the following:
I thought the topic was related to a NCE or NBE! So the example of benzyl alcohol is not appropriate in this context since it was approved as a 505(b)(2) and the chemical is well known and even available as in OTC cosmetics, shampoos, OTC topical drugs etc.....
In the second example, raxibacumab as a "product name" for marketing was submitted in the original BLA by the sponsor for the FDA review  (i.e. the sponsor requested that the product name for marketing as being "Raxibacumab) and also re-submitted (after the first rejection) to the FDA with draft marketing labels and subsequently the FDA approved the BLA after reviewing the proposed "product name" as "Raxibacumab" by the sponsor. Only after this approval, the company was able to market it. Its worth reviewing the FDA labeling review comments.

Check the language in the approval letter  "You  may label your product with the proprietary name raxibacumab and will market it in 1700 mg vials."
 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125349Orig1s000ltr(r).pdf

The most important point was that raxibacumab is not a typical approval based on human studies. This product approval was based on animal rule/animal efficacy studies due to the  emergency anthrax attacks in the US and is not typically prescribed like any other NCE/NBE therapeutic which is based on human pivotal studies. 
FDA labeling approval language for this product states: "The product labeling and patient information sheet adequately  address the requirement of the animal rule regarding information to be provided to patients [21 CFR 601.91 (b)(3)]"

Hope this is helpful






Original Message:
Sent: 27-Dec-2018 14:08
From: Glen Park
Subject: Brand name requirement-US / EU

As I and others have noted, it would be highly unusual for a company to attempt to commercialize a NCE/NME without a proprietary name. The example I provided that was approved in 2009 (benzyl alcohol for treatment of head lice) was approved with the posted label listing the brand name as BRANDNAME and a subsequent supplement implemented the proprietary name as ULESFIA. There was no prohibition against the manufacturer marketing the product as BRANDNAME indicated in the approval letter.

Maybe more to the point is that raxibacumab was approved in 2012 as an original BLA for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. The labeling does not have a "proprietary" name per se.

These examples provide clear evidence that FDA does not require a proprietary name to approve a medical product or to make it available for sale and distribution.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 27-Dec-2018 10:17
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

Unless someone furnishes an NCE or NBE which was or is being currently marketed without a brand name as an example, this regulatory issue would remain unanswered. Just imagine a physician writing only a chemical/biological name for an indication as a prescription with no prior history? One cannot tell whether it is a NCE which was newly approved and requires a careful review versus a generic drug which is not a NCE!!! I think that this would create a safety issue and confusion.
Original Message:
Sent: 27-Dec-2018 10:02
From: Glen Park
Subject: Brand name requirement-US / EU

While I think this question has been adequately answered, I think there remains some confusion. The original question was whether a marketing application required inclusion of a brand or proprietary name, and whether the product could be approved with an internal code/name, with a qualification that the question was a regulatory question and NOT from a business/commercialization perspective.  The answer to the regulatory question is that there is NO requirement for a proprietary name to be included in the marketing application nor is there a regulatory requirement for a approval of a proprietary name for FDA to approve the application. I cited one precedent of a product approved post PDUFA IV to support this conclusion.

Colleagues who have questioned whether this conclusion is true are, I think, looking at the question from a commercial perspective. There is no question that there is a commercial need to establish a brand that is unique to the applicant. PDUFA IV and the subsequent guidance lay out the process for approval of a product with a proposed proprietary name, including writing a guidance on what constituted a "complete application" when a proprietary name is proposed.

It is important for regulatory professionals to distinguish between what the laws and regulations actually require and what may be in the best interest of a company that intends to market a commercially viable product. Otherwise, we cannot always provide the best advice to our industry.

------------------------------
Glen Park
Jersey City NJ
United States

Original Message:
Sent: 20-Dec-2018 14:29
From: Anonymous Member
Subject: Brand name requirement-US / EU

This message was posted by a user wishing to remain anonymous

I was asked this rather generic question, and am not really sure if there is a definitive yes or no type of answer to it (i have no previous experience with this process) - for an NME, is there a regulatory requirement to have a brand name as part of the BLA when applying for approval in the US, and same for an MAA when applying to the EMA? i.e. does the brand name have to be included as part of the application in either of these regions? can a new product be approved with say an internal company code/name? (the question is purely from a regulatory requirement perspective, not a business/commercialization perspective).

Below is what i found here (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf) but not sure if it distinguishes b/w brand and generic or that it even implies there is a need to have one.

"According to Article 1(20) of Directive 2001/83/EC (ref2), it should be noted that the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder"."

any insights would be really helpful.
thanks,
A.Non