FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for March 2016

Posted on Friday, March 25 2016 at 5:00 pm by -

Amgen Opposes Supreme Court Review on Pre-Commercial Notice Provision in Amgen v. Sandoz But Files Cross-Petition on Whether Patent Dance Is Mandatory

 By: Jennifer Giordano-Coltart, Ph.D.

We recently posted on Sandoz Inc.’s petition for writ of certiorari that was filed February 16, 2016 requesting U.S. Supreme Court (Supreme Court) review of the U.S. Court of Appeals for the Federal Circuit’s (Federal Circuit) interpretation of the pre-commercialization notice provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  In that case, the Federal Circuit held that, “under paragraph (l)(8)(A), a subsection (k) [of the BPCIA] applicant may only give effective notice of commercial marketing after the FDA has licensed its product.”[1]
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Posted on Tuesday, March 8 2016 at 3:13 pm by -

With Deadline Looming for Vermont’s GMO Law, Will Congress Pass Legislation to Address GMO Labeling?

By: Carolina M. Wirth 

There was a lot of activity last week on Capitol Hill in an effort to pass legislation that would address the labeling of Genetically Modified Organisms (GMOs) before the July 1, 2016 implementation date of Vermont’s Act 120[1] (and accompanying Rule 121).  Act 120 will be the first mandatory labeling law that requires food produced with genetic engineering (GE) to be labeled as such.[2]  The law applies to raw agricultural products (e.g., corn, squash) and processed foods (e.g., crackers, soda, cereals), that are sold in stores in the state of Vermont.  Manufactures will need to label food products as either: (1) “produced with genetic engineering,” (2) “partially produced with genetic engineering,” or (3) “may be produced with genetic engineering.”  The law also prohibits such foods from being labeled “natural” and sets out statutory damages of “not more than $1,000.00 per day, per product” for violations of the Act.  As the implementation date gets closer, the food industry continues to advocate to Congress to find a solution that will prevent the creation of multiple state specific labeling standards for products that are produced with GMOs.

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