Members of Congress Call on FDA to Protect Generic Drugs

In response to Monday's Supreme Court decision in Mutual v. Bartlett, ruling that generic drug companies cannot be held responsible for the design of the drugs they make, members of Congress have sent a letter to the FDA urging for action to address the disparity between the safety requirements for brand and generic drugs.


The letter from Senators Leahy, Harkin, Franken and Representatives Waxman, Van Hollen, Braley, and Cartwright reads, "We urge the FDA to expedite its review of the current rules governing generic drug labeling changes and promulgate regulations to ensure that generic drug manufacturers can improve the warning information for their products in a manner similar to that available to brand-name manufacturers. Responsible brand-name and generic manufacturers alike should have the ability, and the obligation, to give doctors and patients the information they need to avoid injuries."