September 25, 2018
A long-standing U.S. Supreme Court doctrine shielding companies that petition the U.S. Food and Drug Administration from antitrust liability is proving increasingly unhelpful to brand-name drugmakers accused of delaying generic-drug rivals by bombarding the FDA with cockamamie scientific arguments.
April 11, 2018
The Federal Trade Commission on Wednesday appealed its stinging loss to Shire ViroPharma Inc. in a landmark case that alleges abuse of the U.S. Food and Drug Administration's citizen petition process to delay competition from generic drugs.
March 22, 2018
The Federal Trade Commission suffered a big setback when a Delaware federal judge axed its milestone challenge to ViroPharma Inc.'s anti-generic maneuvering, but the agency simultaneously notched a victory that will impede drugmakers from quickly beating similar challenges in the future.
March 20, 2018
The Federal Trade Commission on Tuesday lost its first-ever legal assault on drugmaker efforts to delay generic competition by constantly petitioning the U.S. Food and Drug Administration, even as a Delaware federal judge identified potential antitrust violations by Shire PLC unit ViroPharma Inc.
April 10, 2017
Shire ViroPharma Inc. on Monday hammered a Federal Trade Commission antitrust suit over alleged abuse of the U.S. Food and Drug Administration's citizen petition process to delay generic competition, calling it procedurally improper and an affront to constitutional rights.
February 08, 2017
The Federal Trade Commission's first-of-its-kind lawsuit alleging abuse of the U.S. Food and Drug Administration's citizen petition process will shed light on when drugmaker efforts to delay generic competition cross a blurry line between free speech and obstruction, experts say.
February 07, 2017
A unit of Shire PLC was hit with a suit Tuesday by the Federal Trade Commission accusing the company of clogging the approval pipeline for a generic version of its gastrointestinal infection treatment with a record number of filings that delayed approval by two years.