Issue 1 : January/February 2003
First Amendment
January/February 2003
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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.
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 CommitteeA 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
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.)

