Public Citizen Litigation Group: Industry’s Relentless Adversary
Executive Summary
Public Citizen Litigation Group has had plenty to cheer about this year. It argued four cases before the U.S. Supreme Court, winning three of them. Its one loss was particularly disappointing, though
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Pain drugs with safety questions will get advisory committee review
FDA will hold a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Jan. 30 to weigh the available safety and efficacy data for all propoxyphene-containing products (including hydrochloric acid, napsylate salts and combination drugs) and decide whether any regulatory action is appropriate. In June 2008, Public Citizen Litigation Group sued FDA for failing to withdraw products containing the painkiller propoxyphene, including AAIPharma's Darvocet (1"The Pink Sheet," July 7, 2008, p. 26)
Pain drugs with safety questions will get advisory committee review
FDA will hold a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Jan. 30 to weigh the available safety and efficacy data for all propoxyphene-containing products (including hydrochloric acid, napsylate salts and combination drugs) and decide whether any regulatory action is appropriate. In June 2008, Public Citizen Litigation Group sued FDA for failing to withdraw products containing the painkiller propoxyphene, including AAIPharma's Darvocet (1"The Pink Sheet," July 7, 2008, p. 26)
FDA Preemption Deadlocks Supreme Court; Congress Pushes To Resolve Issue
Citing a crisis within FDA, members of Congress are demanding that the agency withdraw its proposed rule to limit when drug and device manufacturers can revise their product labeling without prior FDA approval