Record of Telephone Conversation, April 7, 2014 - RAGWITEK

RECORD OF TELEPHONE CONVERSATION
 Submission Type: BLA Submission ID: 125478/0
 Office: OVRR
 Product:
 Short Ragweed Pollen Allergen Extract
 Applicant:
 Merck Sharp & Dohme Corp.
 Telecon Date/Time: 07-Apr-2014 02:06 PM
 Initiated by FDA? Yes
 Telephone Number: 
 Communication Categorie(s):
 1. Information Request
 Author: ELIZABETH VALENTI
 Telecon Summary:
 Request for agreement on Phae 4 PMCs.
 FDA Participants: None
 Non-FDA Participants: None
 Trans-BLA Group: No
 Related STNs: None
 Related PMCs: None
 Telecon Body:
From: Valenti, Elizabeth 
Sent: Monday, April 07, 2014 2:06 PM
To: Scott Greenfeder Ph. D. (scott.greenfeder@merck.com)
Cc: Rivers, Katie; Valenti, Elizabeth
Subject: RAGWITEK PMCs

Dear Scott,

Below are the synopsis of the proposed Postmarketing Commitments (PMCs) for RAGWITEK under STN 125478/0. Please send us your concurrence as soon as possible through email and also submit it as an amendment to your BLA as soon as possible.

1. You commit to conduct a postmarket claims-based study of serious allergic reactions in marketed use of RAGWITEK in the United States. The study will enroll all new users of RAGWITEK identified through claims data from a large U.S. health insurance database for a period of at least three years from launch of RAGWITEK. The study observation period will last for at least 3 years and until at least 10,000 patients are accrued between both postmarket studies. Outcomes of interest identified through claims data will be verified using medical record review.

Final protocol submission date: January 31, 2015.

Study completion date: June 30, 2017 (projected).

Final Report Submission date: June 30, 2018 (or one year after study completion date, whichever is later).

2. You commit to conduct a postmarket electronic medical record study of serious allergic reactions in marketed use of RAGWITEK in the United States. The study will enroll all new users of RAGWITEK identified through electronic medical records in a large U.S. integrated health system for a period of at least three years from launch of GRASTEK. The study observation period will last for at least 3 years and until at least 10,000 patients are accrued between both post-market studies. This study will include early exposures to RAGWITEK, including administration through starter packs provided in physician offices as well as all subsequent exposures.

Final protocol submission date: November 30, 2015.

Study completion date: June 30, 2017 (projected).

Final Report Submission date: June 30, 2018 (or one year after study completion date, whichever is later).

Thank you, Betsy

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

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