Hi Michael.
I love your postings because of the precision of the statements made. However, in this case, I do have what might be a follow-up to the original question and then your answer. I had thought that FDA had been sued in the recent past (maybe last 3 years or so) because of their disparate readings of the term "date" in the statute. Specifically, if a product application is received after-hours (I believe 4:30 PM Eastern time) by the FDA, the FDA deems the receipt date for all reporting purposes to be the next business day but the FDA for purposes of determining when a product is actually approved for patent extension decisions the date on the letter, regardless of when the letter is actually received by the sponsor is the date of approval. I had thought FDA lost that case but maybe I am wrong here.
But, if I am correct, it would seem that the date of receipt by the manufacturer during which the manufacturer can actually act upon the approval (e.g., ship or manufacture product to the field) would be the date on which the NCE should also be calculated.
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Victor Mencarelli
Sr. Manager - Regulatory Affairs
Hain Celestial Group
United States
Original Message:
Sent: 04-28-2016 15:38
From: Michael Swit
Subject: NCE exclusivity Timing
To be absolutely precise, it is from the approval date as it appears on the actual approval letter.
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______________________________________________
Michael A. Swit, Esq.
Sr. Director, Legal, Regulatory
Illumina, Inc.
www.illumina.com
San Diego, CA
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