CONGRESS URGES THE FDA TO CHANGE GENRIC DRUG APPROVAL RULES
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
By: Kelda Doherty
Following the Supreme Court ruling in Mutual Pharmaceutical Co. v. Bartlett, which allowed generic manufactures to avoid state law liability for defectively designed drugs, members of congress have spoken out against this ruling. Congressional members and consumer groups renewed their plea for the FDA to change their generic drug approval rules in order to ensure that those consumers injured by generic drugs can seek redress through the courts. As it stands, generic drug manufactures cannot be sued by state law as it would conflict with federal law, however three senators and four representatives, all of whom were Democrats were of the opinion that this law needs revising.