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Issue 4 : July/August 2004

Update 2004, Issue 4: Uncle Sam at the Border, Part II
Uncle Sam at the Border—Part 2: Counterfeits, Reimports, and Interagency Outreach

July/August 2004

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

 

 

Feature Articles


Drug Diversion and Counterfeiting:
Can RFID “Track & Trace” Technology Protect Consumers?
by Matthew B. Van Hook, Senior Counsel and co-chair of the Food and Drug Team in the law firm of Holland & Knight, LLP, Washington, D.C.
and George Y. Wheeler, III, Partner and member of the Telecommunications Team in the law firm of Holland & Knight, LLP, Washington, D.C.

Belts + Suspenders = Risk Management at the Borders → Benefits for Importers of FDA-Regulated Goods
by Deane Anne Johnson, Of Counsel with the law firm of Sandler, Travis & Rosenberg, P.A., Washington, D.C.

Importing FDA-Regulated Merchandise: Seizures and Penalties
by J. Steven Jarreau, Attorney in the Office of Regulations and Rulings, U.S. Customs and Border Protection, Washington, D.C.

Purchases of Prescription Drugs From Canadian Internet Pharmacies:
The Canadian Legal Regime

by Brian R. Daley, Partner in the law firm of Ogilvy Renault, Montreal, Quebec, Canada

Focus on Canada: The Cost of Canadian Drug Prices
by Jamie M. Davis, graduate student in the Quality Assurance and Regulatory Affairs Program sponsored by the Temple University School of Pharmacy

 

Also In This Issue


Desperately Seeking an FDA Commissioner
by Henry I. Miller, M.D., a fellow at the Hoover Institution and the Competitive Enterprise Institute, Stanford University, Stanford, CA

Beginning Steps for PBM Reform
by David A. Balto, former Head of the Policy Office of the Bureau of Competition of the Federal Trade Commission and practices antitrust law in Washington, D.C.

Practical Issues With PBM Full Disclosure Laws
by Lawrence W . Abrams, Ph.D., an economist with Nu-Retail, Mountain View, CA

New Medicare Act Provides New Competitive Landscape for the Pharmaceutical Industry
by Stephen Paul Mahinka, partner in the Antitrust and FDA/Healthcare Regulation practice groups, and Chair of the Life Sciences Practice, at Morgan Lewis & Bockius, LLP, Washington, D.C.
and Kathleen M. Sanzo, Partner in the FDA/Healthcare Regulation Practice Group and a member of the Morgan Lewis Life Sciences Practice, Washington, D.C.

The Clinical Aspects of Claim Substantiation: Clinical Trial Costs
by Ioana G. Carabin, M.D., President and Medical Director of Women Health Sciences Institute, Vero Beach, FL

Warning: Eating Causes Cancer and Birth Defects (in California)
by Trenton H. Norris, Partner in the law firm of Bingham McCutchen LLP, San Francisco, CA

 

Columns


Making History
Ruth de Forest Lamb: FDA’s First Chief Educational Officer
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
Attorneys’ Confidential Communications: The Continued Assault
by Steven M. Kowal, Chair of the White Collar Criminal Defense Group at the law firm of Bell, Boyd & Lloyd LLC, Chicago, IL

Global Corner
Medical Device Reimbursement: Planning Early to Meet Future Challenges
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, D.C.

Associates’ Corner
The Overlooked Costs of Legislation to Expand Drug Imports
by Patricia J. Kaeding, Associate in the law firm of Godfrey & Kahn, SC, in Madison, WI

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

 

 

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

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