Update Nov Dec 2013 - (Page 6)

PREPAREDNESS letter from the president & ceo The Blumberg Memorial Lecture Published by the Food and Drug Law Institute I FDLI www.fdli.org am crafting this message in early October, in the midst of what I hope is the about-to-conclude partial The of the federal government. As the nation (and particularly those of us shutdown Bioterrorism Act after 5 Years - Is it Working? based in the Washington BioShield phrases such as 'excepted activities' and 'funding lapse', many are more aware of DC area) internalize new II - A Step in the Right Direction? federal government employees and the roles they play. demic Influenza: Companies Should Plan for the Worst and Assess Legal Exposure Liability Protection:and drug law community lost a well-known and widely respected public servant Earlier this year, the food Shielding Vaccine Makers from Litigation in Food Recall - Exposing Holes in U.S. Food Safety Defenses Petthe federal government. Rick Blumberg, FDA's then Deputy Chief Counsel for Litigation, passed away unexpectedly in early March. (You may recall that we acknowledged Rick's passing, and that of George Burditt, Gene Lambert, and Jerry Heckman, at our Annual Conference in April.) Rick had invested 42 years at FDA's Office of the Chief Counsel (OCC), and headed the litigation effort for twenty years. In that time, he established an indelible stamp on the Agency, in the courtroom, and in case law. He was rarely (if ever) described as shy or retiring; quick-witted, intelligent and, frankly, irascible, were more likely descriptors. Worthy opponent was another. A frequent contributor to FDLI events, participants knew to expect candor and wisdom from his podium. At one of those conferences, he leaned over to me as we sat in the back of the room to observe that "They [the speaker from the private bar] always use more slides to discuss their wins than their losses. You should do something about that." After I responded that I could, but that the same limit would apply to him and other FDA attorneys, he said something along the lines of "Never mind. Bad idea. And we have more wins to discuss anyway." His work with his OCC colleagues was exemplary as well. As described in his memoriam, he "nurtured the careers of dozens of food and drug lawyers who carry on his legacy at FDA and throughout the food and drug law community." In recognition of his many contributions, the FDLI Board of Directors established the Eric M. Blumberg Memorial Lecture, a featured address at our yearly Enforcement, Litigation and Compliance Conference. The theme of the lecture is the role of enforcement in safeguarding public health; we expect speakers throughout the years to include FDA officials and other prominent stakeholders in our community. To extend the reach beyond those attendees, we will publish the entire speech in the Food and Drug Law Journal. The inaugural Eric M. Blumberg Memorial Lecture will be presented on December 11th at the 2013 Enforcement Conference by Annamarie Kempic, the current Deputy Chief Counsel for Enforcement at FDA. Annamarie served as Rick's right-hand person for many years and is just the right person to deliver the first address. We hope you will be able to join us at the meeting, and take a moment to remember a true public servant. Susan C. Winckler President and CEO 6 Update November/December 2013 www.fdli.org Pand http://www.fdli.org

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Update Nov Dec 2013