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
*PLIVA v. Mensing, 131 S. Ct. 2567 (2011)
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