May 28, 2010
FDA Certification No Shield to Suit Against Generic Drug Makers
Generic drug manufacturers are not insulated from lawsuits by an FDA approval process that certifies such drugs as the “bioequivalent” of their brand-name predecessors, a federal judge has ruled. The judge refused to dismiss a suit brought by consumers who were taking Wellbutrin, a brand-name antidepressant, and who claim they had side effects upon switching to a generic. The suit alleges that two drug manufacturers failed to warn the public about differences that affected the release of the product’s active ingredient.