Record of Telephone Conversation and Email, March 27, 2013 - RAGWITEK

Submission Type: BLA Submission ID: 125478/0 Office: OVRR
Product:
Short Ragweed Pollen Allergen Extract
Applicant:
Merck Sharp & Dohme Corp.
Telecon Date/Time: 27-Mar-2013 12:05 PM Initiated by FDA? Yes
Telephone Number: ---(b)(6)--------
Communication Categorie(s):
1. Advice
Author: KATIE RIVERS
Telecon Summary:

Discussion regarding the proper name of the product, the requirement for proprietary name to be included on product blister packaging, and appropriately filling out the 356h
form for amendment submission.

FDA Participants:
LCDR Elizabeth J. Valenti, MPH, RAC, REHS/RS
Katie Rivers, M.S.
Non-FDA Participants:
Scott Greenfeder, Ph.D.
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:

Ms. Rivers and LCDR Valenti called Dr. Greenfeder to follow-up on the below e-mail communication regarding inclusion of the proprietary name on the product blister packaging. CBER clarified that inclusion of the proprietary name is required on the blister packaging and that a product would be considered misbranded should the proprietary name be excluded from the product packaging. Dr. Greenfeder explained that Merck is concerned that the final proprietary name may not be approved prior to manufacturing product launch lots. CBER informed Dr. Greenfeder that we will review the PNR within 90 days of receipt and that CBER will re-review the PNR within 90 days of BLA approval. CBER asked Dr. Greenfeder when the sponsor plans to start manufacture of their product. He responded that the dates are not finalized, but the timeframe for blister pack printing is between the end of March and June and product manufacturing should begin in June. We discussed that Merck submitted one name in their Proprietary Name Review (PNR) amendment. If the name is found unacceptable then Merck will need to resubmit a new PNR. Dr. Greenfeder advised that he would inform his team of the decision. Merck plans to resubmit package labeling based on the proper name CBER has agreed upon, this will include the blister pack labeling as well as carton and container labeling. Changes to the package insert will be made during labeling negotiations.

We also advised the sponsor on how to appropriately complete for 356h for submission of an amendment. CBER informed Dr. Greenfeder that the “Other” option within box 21 of form 356h should not be chosen and should be left blank if an appropriate choice is not available. CBER also advised that in order to expedite processing of amendments by the document control center (DCC), the “Amendment” option in box 22 of form 356h should be chosen.

We thanked each other and the call ended.

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From: Greenfeder, Scott [mailto:scott.greenfeder@merck.com]
Sent: Wednesday, March 27, 2013 11:25 AM
To: Valenti, Elizabeth
Cc: Sweeney, Colleen; Rivers, Katie; Chattopadhyay, Rana
Subject: RE: BLA 125,478 for MK-3641
Importance: High
Dear Betsy et al.,

Thank you for the clarification and for outlining the Division’s position regarding the proper name and form. Taking this into consideration we plan in the very short term to update our component labeling for both products to reflect the Division’s opinion.

The proper name for Ragweed will be: Short Ragweed Pollen Allergen Extract
The proper name for Grass will be: Timothy Grass Pollen Allergen Extract

The form for both products will be: tablets for sublingual use

Based on these changes we will submitted updated component labeling to both BLA 125473 and 125478 for review.

We intend to make the same changes in other product labeling; however, we will wait to do so until labeling review is undertaken.

I also wanted to follow up on the further question regarding our proposal to not include a Trade Name on the internal tablet blister packs for the initial launch batches. As I indicated in my email below, manufacturing must be initiated for both of these products prior to final approval of the PNR. The products are manufactured directly into the blister packaging. The foil lidding of the blister packs must be printed prior to assembly of the blister. If we include a Trade Name on the blister that ultimately is not approved we will lose the entire launch batch of each product. We are proposing to not include the Trade Name on the blister to mitigate this risk. I also want to make it clear that the blister pack will be contained within an outer packaging component. The outer packaging component will display the approved Trade Name as printing of these materials can be delayed until after PNR approval. Since there was no comment regarding this matter in the original email Merck currently assumes that CBER does have disagreement with this approach. Please provide any comments if this is not the case.

Thank you all for your attention to this matter.

Regards,
Scott
Scott Greenfeder, Ph.D.
Associate Director and Liaison
Global Regulatory Affairs
T: +1 732-594-1021
Fax: +1 732-594-1030
scott.greenfeder@merck.com
Merck Research Labs
126 East Lincoln Ave.
MS RY33-204
Rahway, NJ 07065
www.merck.com

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From: Valenti, Elizabeth [mailto:Elizabeth.Valenti@fda.hhs.gov]
Sent: Tuesday, March 26, 2013 4:12 PM
To: Greenfeder, Scott
Cc: Sweeney, Colleen; Rivers, Katie; Valenti, Elizabeth
Subject: RE: BLA 125,478 for MK-3641
Dear Scott,

There was an error in the below email. The proper name is "Short Ragweed Pollen Allergen Extract."

Regards,
Betsy

Elizabeth J. Valenti, MPH, RAC (U.S.), REHS/RS
LCDR, USPHS
FDA/CBER/OVRR/DVRPA
1401 Rockville Pike
Mailstop HFM-481
Rockville, MD 20852
(301) 796-2640
elizabeth.valenti@fda.hhs.gov

--------------------------------------------

From: Valenti, Elizabeth
Sent: Monday, March 25, 2013 10:59 AM
To: 'Greenfeder, Scott'
Cc: Sweeney, Colleen; Rivers, Katie; Valenti, Elizabeth
Subject: RE: BLA 125,478 for MK-3641
Dear Scott,

Product that does not contain the correct proper and proprietary name cannot be distributed.

We have held internal discussions regarding the proper name and form. The proper name is "Short Ragweed Allergen Extract." The form is "Tablet for sublingual use." As you noted below, labeling is not final until the BLA is approved. While we have held internal discussions and feel strongly regarding the proper name and form, the proper name, proprietary name, and form are subject to change during labeling negotiations.

Thank you; we received your proprietary name review (PNR) request.

Ms. Katie Rivers, M.S. and CAPT Colleen Sweeney, M.S. are the RPMs for this BLA. Please direct future emails to them and include me as necessary. I have been assigned as the Chair for this BLA.

Regards,
Betsy

Elizabeth J. Valenti, MPH, RAC (U.S.), REHS/RS
LCDR, USPHS
FDA/CBER/OVRR/DVRPA
1401 Rockville Pike
Mailstop HFM-481
Rockville, MD 20852
(301) 796-2640
elizabeth.valenti@fda.hhs.gov

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender immediately by e-mail or phone.

-----------------------------------------

From: Greenfeder, Scott [mailto:scott.greenfeder@merck.com]
Sent: Thursday, March 14, 2013 1:01 PM
To: Valenti, Elizabeth
Cc: Sweeney, Colleen; Rivers, Katie
Subject: RE: BLA 125,478 for MK-3641
Betsy,

Due to the timing constraints and internal process the work to produce the blister pack components is underway. Any need to change the blister packages will result in a delay in launch supply manufacturing on our end which could jeopardize getting product out to patients for the 2014 ragweed season.

Thank you for your help with this.

Regards,
Scott
Scott Greenfeder, Ph.D.
Associate Director and Liaison
Global Regulatory Affairs
T: +1 732-594-1021
Fax: +1 732-594-1030
scott.greenfeder@merck.com
Merck Research Labs
126 East Lincoln Ave.
MS RY33-204
Rahway, NJ 07065
www.merck.com

--------------------------------------------

From: Valenti, Elizabeth [mailto:Elizabeth.Valenti@fda.hhs.gov]
Sent: Thursday, March 14, 2013 9:02 AM
To: Greenfeder, Scott
Cc: Sweeney, Colleen; Rivers, Katie
Subject: RE: BLA 125,478 for MK-3641
Dear Scott,

Were these launch lots already manufactured?

Thank you, Betsy

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender immediately by e-mail or phone.

--------------------------------------------

From: Greenfeder, Scott [mailto:scott.greenfeder@merck.com]
Sent: Wednesday, March 13, 2013 7:54 AM
To: Valenti, Elizabeth
Cc: Sweeney, Colleen
Subject: RE: BLA 125,478 for MK-3641
Betsy,

There is an aspect of our filing that I would like to bring to your attention. As indicated in the cover letter we have proposed to label our internal blister package for the tablets with only the generic name for the launch batches. As is laid out, this is to mitigate the potential that the chosen trade name may not be acceptable. Due to the manner of manufacture (tablets are manufactured into the pre-printed blisters) and the timing needed this was the best way we could come up with to mitigate the blister print issue. It is our intent that the outer cartons as well as all other labeling components will contain the approved trade name for the launch supply.

Again, it is also our intent to only employ this strategy for the initial launch supply. I understand that typically labeling does not get fully reviewed until later in the review process. However, if there is any way that we can get feedback earlier on whether this is an acceptable approach that would be of tremendous help.

Many thanks,

Regards,
Scott
Scott Greenfeder, Ph.D.
Associate Director and Liaison
Global Regulatory Affairs
T: +1 732-594-1021
Fax: +1 732-594-1030
scott.greenfeder@merck.com
Merck Research Labs
126 East Lincoln Ave.
MS RY33-204
Rahway, NJ 07065
www.merck.com
