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Issue 1 : January/February 2003

 

Update 2003, Issue 1: First Amendment

 

 

First Amendment

January/February 2003

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

 

 

 

Feature Articles


FDA Involvement in Product Liability Lawsuits

by Daniel E. Troy, Chief Counsel of the Food and Drug Administration, Rockville, MD.
This article is adapted from remarks originally delivered at FDLI's annual Advertising and Promotion Conference, September 11-12, 2002.

Enshrining a Constitutional Right to Engage in Pharmaceutical Advertising
by Lars Noah, Professor of Law at the University of Florida, Gainesville, FL

History, Decision, and Aftermath of Thompson v. Western States-Drug Advertising and the First Amendment
by Howard M. Hoffmann, Senior Litigation Partner and Trial Attorney in the law firm of Duane Morris LLP, Chicago, IL. Mr. Hoffman represented the pharmacies at every level of the Western States litigation.

Western States Medical Center:
A Watershed Moment for FDA's Regulation of Commercial Speech

by Jeffrey N. Gibbs, Partner in the law firm of Hyman, Phelps & McNamara, PC, Washington, D.C.,
and Jeffrey N. Wasserstein, Associate in the law firm of Hyman, Phelps & McNamara, PC, Washington, D.C.

First Amendment: Is It Hazardous to Your Health? Government Regulation v. the Constitution
by Garry A. Courtney, Senior Regulatory Affairs Specialist with Terumo Cardiovascular Systems, Elkton, MD

Starstruck: Celebrity Endorsements, Talk Television, and Prescription Drugs
by Praveen D. Fernandes, Associate in the law firm of Ropes and Gray, Washington, D.C.

 

Also In This Issue


The OIG's Draft Compliance Guidance for Pharmaceutical Manufacturers: One More Compliance 'Script' for the Healthcare Industry

by Wendy C. Goldstein, Health Law Partner in the law firm of Epstein Becker & Green, New York, NY., and Chair of the firms Pharmaceutical Health Regulatory Practice Group,
and Lynn Shapiro Snyder, Health Law Partner in the law firm of Epstein Becker & Green, Washington, D.C., Chair of the firmsThird Party Payment Practice Group, and Co-Chair of the Health Care Fraud and Abuse Practice Group.

Value-Added Program Review Committee—A Key Step Toward Effective Corporate Compliance
by Harvey A. Sussman, Of Counsel in the law firm of Kleinfeld, Kaplan and Becker, Washington, D.C.,
and Stacy L. Ehrlich, Partner in the law firm of Kleinfeld, Kaplan and Becker, Washington, D.C.

Pharmaceutical Patient Assistance Programs:
OIG Can Take a Dim View of "Charity"

by Harvey A. Yampolsky, Member of the Health Practice Group in the law firm of Arent Fox Kintner Plotkin & Kahn, PLLC, Washington, D.C., and former Chief Counsel to the Inspector General, DHHS.,
and Howard J. Young, Member of the Health Practice Group in the law firm of Arent Fox Kintner Plotkin & Kahn, PLLC, Washington, D.C., and former Deputy Chief, Civil Recoveries Branch, OIG.

A Rose Is Indeed a Rose: FDA's Proposal for Protection of Patents for Alternate Forms of Active Ingredients
by John Barlow Weiner, Associate in the life sciences and environmental groups of the law firm of Ropes and Gray, Washington, D.C.

"Toward Larger and Better Regulation":
China's New Safety Evaluation Regulation on Agricultural GMOs

by Cynthia Blumenthal, Specialist in Regulatory Affairs with Genencor International, Inc., Palo Alto, CA

 

Columns


Making History

Hearing Out Hudson: FDA and Commercial Free Speech
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
The Standards for Effective Corporate Compliance Programs Have Increased
by Steven M. Kowal, Partner in the law firm of Bell, Boyd & Lloyd, Chicago, IL

Global Corner
Combination Products Present New Challenges
by Matthew Weinberg, Chief Executive Officer of THE WEINBERG GROUP INC., Washington, D.C.

Associates' Corner
Out for Blood: Plaintiffs Seek Market Share Liability and Alternative Liability in Blood Product Cases
by Jennifer B. Saulnier, Associate in the law firm of Jones, Day, Reavis & Pogue, Pittsburgh, PA

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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