WASHINGTON, Aug. 30, 2011 /PRNewswire/ -- Public Citizen filed a petition with the Food and Drug Administration on Monday saying that the FDA should revise its rules that bar generic drug makers from changing their labels. The group said the generic drug makers should be allowed to ask the FDA to change a drug's label when they learn of new risks to patients who take their drugs. Reporters developing a story might wish to speak with Ralph Pittle, a plaintiff's attorney and former pharmacist. Mr. Pittle currently has about 160 clients who contend that they were harmed as a result of taking metoclopramide, the generic version of the brand-name drug Reglan. Mr. Pittle can also arrange for a reporter to interview one of his clients.
The Public Citizen petition follows a Supreme Court decision of earlier this summer (PLIVA v. Mensing*) in which the court relied on FDA regulations as the basis for its holding that patients harmed by inadequate warnings on a generic drug cannot sue the drug maker for damages, while people who take brand-name version of the same drug can. At present, FDA regulations do not allow generic manufacturers to alter their labeling, even when they become aware that it is inadequate.
Click here for more information about Mr. Pittle's background.
CONTACT: To interview Ralph Pittle, or a client of his firm whose life has been affected by the side effects of a generic drug, please call Wiley Brooks at (206) 963-2230 or email email@example.com
*PLIVA v. Mensing, 131 S. Ct. 2567 (2011)