For The Defense, November 2012 - DRI Today

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son, 535 U.S. at 375. Furthermore, since the FDA probably could achieve the narrowly stated goal of encouraging manufacturers to seek approval for all indications through less restrictive means, the regulation and policies articulated in the FDA draft guidance may only await a constitutional challenge by a manufacturer on First Amendment grounds. Conclusion The FDA’s stated mission is to ensure that all drugs and devices are safe and effective. This is a noble goal which no drug manufacturer, physician, or patient could find fault with. However, the FDA’s prohibition on offlabel marketing and the recent Guidance clarifying its policy on responding to unsolicited requests for offlabel information do little to advance that goal. The net result of recent policy announcements will be that drug manufacturers are too constrained and fearful to provide truthful and valuable information about offlabel uses, even in the limited instances when the Guidance provides an opportunity to do so. Consequently, doctors may not be fully informed and patients may not receive the latest innovative therapies. It is time for the FDA to rethink their policy towards offlabel marketing, and recent First Amendment jurisprudence suggests the courts may be willing to do it for them upon the appropriate challenge. Greater, from page 29 and volunteer to get involved. I think that you will find this committee to be one of the most energized committees in DRI. I have known some of these people for 27 years, and consider many of them to be close friends. Every committee chair should have a vice chair as fantastic as Patrick Sweeney. Pat is great to work with. Our Law Institute representative is Paul Lavelle. I have known Paul for decades. Paul takes his job with the Law Institute extremely seriously and really encourages this committee to improve with each year. When you see the programs and the quality of the speakers that we have, think of all the hard work that Paul Lavelle put into the programming, and understand that Anne Talcott and James Weatherholtz have worked nights and weekends to put this next seminar together. I have a great committee. I want to make it greater. If you ever think of anything that we can do to improve the committee, please shoot me an email or give me a call. I look forward to seeing everyone in April! 2013 Seminar Schedule January 24–25 January 31– February 1 February 28– March 1 March 13–15 March 20–22 March 21–22 April 3–5 April 10–12 April 24–26 Fire Science and Litigation FireSky Resort, Scottsdale, AZ Civil Rights and Governmental Tort Liability Arizona Biltmore, Phoenix, AZ Toxic Torts and Environmental Law The Ritz-Carlton, New Orleans, New Orleans, LA Women in the Law Eden Roc Renaissance Miami Beach, Miami Beach, FL Trial Tactics Paris Las Vegas, Las Vegas, NV Medical Liability and Health Care Law Eden Roc Renaissance Miami Beach, Miami Beach, FL Product Liability Conference Gaylord National, National Harbor, MD Insurance Coverage and Claims Institute Swissôtel Chicago, Chicago, IL Life, Health, Disability and ERISA Claims Westin Copley Place, Boston, MA 82 ■ For The Defense ■ November 2012
Advocates Jackson H. Ables III, Jackson, MS Lucinda H. Alfieri, New York, NY Robert B. Anderson, Wilmington, DE Alison Y. Ashe-Card, Winston Salem, NC Shaun McParland Baldwin, Chicago, IL Whitney Kirkpatrick Barrows, Boston, MA Jeremy Edward Beal, Fullerton, CA Peter Blomquist, Houston, TX Matthew J. Boettcher, Bloomfield Hills, MI Douglas M. Borochoff, Tulsa, OK Advocates and New Members Each month, DRI welcomes new members from the United States and Canada and abroad. Some of these new members have been recommended by current members actively involved in advancing goals shared by DRI. Any individual who recommends a new member is recognized as an “Advocate” for DRI. John S. Bradford, Lake Charles, LA C. William Bradley, Jr., New Orleans, LA Sean P. Byrne, Glen Allen, VA Christopher G. Campbell, New York, NY Rina Carmel, Los Angeles, CA Alexis A. Chmell, Chicago, IL Jessica Cochran, Tampa, FL Clark H. Cole, Saint Louis, MO Darren A. Craig, Indianapolis, IN J. Tyler Dinsmore, Charleston, WV Tony Alan Discoe, Santa Ana, CA Terese A. Drew, Saint Louis, MO Andre Durocher, Montreal, QC Glenn P. Falk, Coral Gables, FL J. Victor Flanagan, Charleston, WV James R. Gallagher, Columbus, OH Christine Gateau, Paris, France Daniel W. Gerber, Buffalo, NY Alessandro P. Giorgetti, Milan MI, Italy Wayne Glaubinger, New York, NY John J. Hainkel III, New Orleans, LA William M. Hake, San Francisco, CA Joseph M. Hanna, Buffalo, NY Michelle Harris, Tulsa, OK Cary E. Hiltgen, Oklahoma City, OK Edward G. Hochuli, Phoenix, AZ James D. Holland, Jackson, MS Michael J. Hudak, Akron, OH John J. Jablonski, Buffalo, NY Glenn A. Jacobson, New York, NY Bonnie Elaine Roberts Jones, Toronto, ON Philip E. Kalamaros, Saint Joseph, MI Richard E. King, New Orleans, LA Joshua Edward Mackey, Poughkeepsie, NY Michael T. McConnell, Denver, CO Terrence R. McInnis, Irvine, CA Stuart P. Miller, Little Rock, AR Julius F. Parker III, Tallahassee, FL Patrick J. Paul, Phoenix, AZ Samuel L. Phillips, San Jose, CA Katherine L. Rhyne, Washington, DC Sherry Ruggiero-Fallon, Wilmington, DE Jeffrey R. Simmons, Phoenix, AZ Josh M. Snell, Phoenix, AZ John R. Trigg, Denver, CO James E. Tyrrell, Jr., Newark, NJ Kristopher T. Wilson, New Orleans, LA Kurt M. Zitzer, Scottsdale, AZ Michael C. Zogby, Florham Park, NJ May 1–3 May 9–10 May 9–10 May 16–17 May 16–17 May 30–31 June 6–7 June 13–14 June 20–21 Employment and Labor Law Arizona Biltmore, Phoenix, AZ Business Litigation InterContinental Chicago, Chicago, IL Intellectual Property InterContinental Chicago, Chicago, IL Drug and Medical Device Sheraton New York Hotel, New York, NY Retail and Hospitality Litigation and Claims Management InterContinental Chicago, Chicago, IL Diversity for Success Swissôtel Chicago, Chicago, IL Insurance Bad Faith and Extra-Contractual Liability Westin Boston Waterfront, Boston, MA DRI International Prague Marriott Hotel, Prague, Czech Republic Young Lawyers The Cosmopolitan of Las Vegas, Las Vegas, NV For The Defense ■ November 2012 ■ 83
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