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Issue 2 : March/April 2009


Opportunities and Challenges Facing FDA & New Administration
March/April 2009

Subscription Information

FDLI members receive Update as part of membership.
Additional copies or back issues are available at $15 each.

 

 


Featured Articles


Personalized Medicine and Healthcare Reform: Is it Time?

by Carol Isaacson Barash, Principal with Genetics, Ethics & Policy Consulting, Boston, MA

The Clock Moves Backwards On FDA’s Drug Review Timelines:
The Impact of FDAAA, REMS, and the Lack of Agency Resources

by Robert F. Church, Partner in the law firm of Hogan & Hartson LLP, San Francisco and Los Angeles, CA

Comparative Effectiveness: Will it Foster FDA-CMS Collaboration
or Drive the Agencies Apart?

by Michael M. Gaba, Partner in the law firm of Holland & Knight LLP, Washington, DC

The Bioterrorism Preparedness and Response Act of 2002:
Yesterday, Today and Tomorrow

by Leslie Alan Glick, Partner in the law firm of Porter, Wright, Morris & Arthur LLP, Washington, DC

FDA Can Help Advance the Administration’s “Prevention” Strategy
by Bruce Silverglade, Director of Legal Affairs, Center for Science in the Public Interest, Washington, DC

Democrats Focus on FDA to Improve Treatment Quality and Reduce Cost
by Marc J. Scheineson, heads the food and drug practice in the law firm of Alston & Bird LLP, Washington, DC



Also In This Issue


FDLI Honors Distinguished Service and Leadership Award Recipients at Holiday Reception: Nancy L. Buc, Geoffrey M. Levitt, Murray M. Lumpkin, MD, MSc and Sanford A. Miller, PhD, Garner Prestigious Awards

Contract Obligations for Access to Experimental Products: What You Say Can Hurt You
by Tracy A. Braun, A full-time student at the Graduate School of Library and Information Sciences, University of Illinois at Urbana-Champaign, IL

Protecting New Investments in Old Drugs
by Terry Mahn, Managing Principal in the law firm of Fish & Richardson PC, Washington, DC

Political Toxicology and its Impact
by Jerome H. Heckman, Partner in the law firm of Keller and Heckman LLP, Washington, DC

The Decline of the DPA: What Has Happened and Why

by Ralph F. Hall, Counsel to Baker & Daniels LLP and Distinguished Visiting Professor at the University of Minnesota Law School and Visiting Professor of Law, Indiana University School of Law, Indianapolis, IN

and

Timothy W. Schmidt, Third-Year law student at the University of Minnesota



Columns


Enforcement Corner

The Curious Case of the Prosecution of Lawyer Paul Kellogg
by John R. Fleder, Principal in the law firm of Hyman, Phelps & McNamara, PC,
Washington, DC

Global Corner
Thriving and Surviving in Lean Times
by Joel I. Falk, Executive Vice President, The Weinberg Group, Washington, DC

and

David E. Schulman, Partner in the law firm of Dechert LLP, Washington, DC

and

Daniel M. Becker, M.D., Partner in the law firm of Dechert LLP, Silicon Valley, CA

Canadian Corner
Canada Could Save Up To $800 Million a Year If There Was More Competitive Generic Drug Pricing
by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada

and

Rebecca Crane, Associate in the law firm of Ogilvy Renault in Toronto, Ontario, Canada

Associates’ Corner
Food Allergen Labeling Without Allergen Thresholds
by Evangelia C. Pelonis, Senior Associate with the law firm of Keller & Heckman LLP,
Washington, DC


(Note: All author affiliations are current as of the date of publication of the issue.)

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