Ralph S. Tyler

Ralph S. Tyler Venable LLP

Results 1 to 5 of 13

FDA shifts focus to prevention with publication of proposed food safety rules *

USA - January 15 2013
On January 4th, the U.S. Food and Drug Administration (FDA) published two long-awaited proposed food safety rules aimed at preventing foodborne…

Co-authors: Matthew Rabinowitz, John G. Moore, Erin E. Seder, Todd A. Harrison.

Second Circuit rules off-label marketing is protected by First Amendment *

USA - December 7 2012
On December 3, 2012, the United States Court of Appeals for the Second Circuit, in a 2-1 opinion, vacated the criminal conviction of a pharmaceutical sales representative for promoting off-label uses of a particular drug.

Co-authors: Matthew Rabinowitz, David G. Adams , Todd A. Harrison, Claudia A. Lewis.

Sales rep’s conviction for off-label promotion of FDA approved drugs is overturned under the First Amendment *

USA - December 7 2012
In a decision that will likely pose significant challenges to the government’s regulation of marketing and promotion of pharmaceuticals and other FDA-regulated products, the Court of Appeals for the Second Circuit invoked the First Amendment in overturning the 2008 conviction of a sales representative for the promotion of a drug for uses not approved by the Food and Drug Administration (“FDA”).

Co-authors: Geoffrey R. Garinther, David G. Adams , Todd A. Harrison, W. Warren Hamel, Claudia A. Lewis.

Appeals Court says First Amendment trumps FDA off-label marketing rules *

USA - December 6 2012
On December 3, the United States Court of Appeals for the Second Circuit overturned the 2008 conviction of Alfred Caronia, a former drug company sales representative, for violating the Food, Drug and Cosmetic Act by introducing a misbranded drug into interstate commerce.

Co-authors: Gregory J. Sater, Leonard L. Gordon , Amy Ralph Mudge, Jeffrey D. Knowles, Randal M. Shaheen.

FTC announces 100th Do Not Call enforcement action *

USA - December 6 2012
This week, the Federal Trade Commission announced its 100th Do Not Call enforcement action since the founding of the National Do Not Call Registry in 2003.