FDA FLASH January, 2014

Mid-Winter Meeting Announcements

  • World’s Fair of IP: The Food and Drug committee will be hosting a booth at the “World’s Fair of IP” committee expo on Thursday, January 30, 2014, from 3:30 – 4:30 PM at the Sheraton Wild Horse Pass, Phoenix, AZ.  Please stop by and see us.
  • Organizational Meeting: The Food and Drug committee will hold a brief, informal committee meeting from 4:30 – 5:30 PM in the “Lobby Bar” of the Sheraton Wild Horse Pass.
  • Networking Event: Right after the Organization meeting, the Food and Drug committee will meet with the Chemical Practice committee, Anti-trust committee, and Patent Litigation committee from 5:30 – 6:30 PM in the Lobby Bar of the Sheraton Wild Horse Pass.  It’s a cash bar, but a great chance to mingle.
  • Biotechnology Dinner:  FYI, the Biotechnology committee is hosting a dinner on January 31st at 6:30 PM at Vintage 95 (http://www.vintage95.com/) in Chandler.  It’s about a ~15 min drive from the conference hotel.  To RSVP and arrange travel, contact Angie Sebor at angela.sebor@globeimmune.com (www.linkedin.com/in/angelasebor/) by Friday, January 24.




Author: Debora Plehn-Dujowich, Ph.D., J.D.  Reviewer: Myra McCormick, Ph.D., J.D

     Associate                                                               Associate Patent Counsel

     Drinker, Biddle & Reath, LLP                             Johnson & Johnson


 ·         FDA Regulation of Animal Feed:  The Food and Drug Administration (FDA) issued proposed rules for the regulation of animal feed.  Read more here.

Lynn Tyler

Author: Lynn C. Tyler, M.S.


Barnes & Thornberg, LLP


 Supreme Court grants cert in POM Wonderful LLC v. The Coca-Cola Co., Docket No. 12-761.

Last Friday, the Supreme Court granted cert to review the Ninth Circuit’s decision in this case and answer the question whether and to what extent the Food, Drug & Cosmetic (FDC) Act, and regulations promulgated under it, preclude a food manufacturer from challenging the label of a competitor’s product under § 43(A) of the Lanham Act, 15 U.S.C. 1125(A).

Briefly, Coke’s Minute Maid division markets a product called “Pomegranate Blueberry” or “Pomegranate Blueberry Flavored Blend of 5 Juices” that contains 0.3% pomegranate juice, 0.2% blueberry juice, and the rest other juices. POM sued Coke under § 43(A) of the Lanham Act, alleging that the products name and label were misleading consumers given that the product is mostly comprised of other juices. The Ninth Circuit held that the FDC Act preempts both the name and labeling aspects of POM’s claim.  The Ninth Circuit’s opinion is available at this link.

  •  FDA Issues draft Guidance partially addressing pharmaceutical promotion through social media.

Earlier this week, the FDA issued a draft Guidance which addresses certain issues related to the promotion of pharmaceuticals through various forms of social media.

This draft Guidance addresses when a firm will be held responsible for content in social media concerning its products and concludes that generally the firm is responsible when it controls the content and not otherwise, even when it may sponsor the particular social media outlet as long as it has no influence over the content. The Guidance also addresses how and how often a pharmaceutical company must submit any content for which it is responsible to the FDA, among other things. A Guidance addressing other issues arising out of the promotion of FDA-regulated products through social media is expected no later than June of this year.  Draft Guidance is available at this link.

 In the News


 Welcome Our New Antitrust Liaison! Ken Frankel is joining us as the Food and Drug committee liaison to the Anti-trust committee that he chairs.  Find out more about Ken at:  http://www.finnegan.com/KennethFrankel/

 Raise Your Visibility: If you have a presentation that you want to give, please email Lynn Tyler lynn.tyler@btlaw.com and Dolly Krishnaswamy djk406@nyu.edu.




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