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Rottenstein Law Group Applauds Public Citizen Petition Asking FDA to Require Increased Vigilance From Generic Drug Makers


(New York, NY, September 13, 2011) The Rottenstein Law Group, which represents clients with claims stemming from the severe side effects of various prescription drugs, commends and supports the petition of the consumer advocate organization Public Citizen, asking the U.S. Food and Drug Administration (FDA) to require greater “pharmacovigilance” from generic drug manufacturers.
RLG has obtained a copy of a “citizen petition” dated August 29, 2011, sent to the FDA by Public Citizen, a not-for-profit organization that lobbies the government on behalf of the general public. This recent petition was likely prompted by the June 23, 2011 U.S. Supreme Court decision in Pilva, Inc. v. Mensing (case no. 09-993) and two related cases. The Supreme Court ruled that Pilva, a generic drug manufacturer, had a complete “impossibility” defense to the claim against it that it had failed to adequately warn consumers of the dangers of a drug it had manufactured, in violation of the laws of Minnesota.
Public Citizen is requesting that the FDA modify its regulations to not only permit, but to require that generic drug manufacturers keep product labels updated to reflect the latest significant potential hazards of the drug, as well as adverse side effects. “Under current regulations,” the petition states, “the FDA has the sole responsibility for updating generic labeling to reflect such hazards, as the generic manufacturer may not revise labeling on its own to reflect newly discovered hazards.”
But, Public Citizen claims, citing a 2009 Supreme Court decision – Wyeth v. Levine – “the FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge.” Concluding that “generic manufacturers’ lack of responsibility for ensuring the post-approval adequacy of product labeling threatens patient safety,” Public Safety has proposed specific new amendments to the current regulations to authorize all drug manufacturers to avail themselves of the so-called “changes-being-affected” (CBE) and “prior-approval-supplement” (PAS) procedures for revision of drug labels.
The Rottenstein Law Group maintains a Web site to provide the most up-to-date information to the public about specific dangerous drugs and defective medical products. Those who wish to obtain more information about harmful drugs and faulty devices will find all relevant information on the site, which is updated regularly as new information becomes available.
About the Rottenstein Law Group
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, a lawyer with over two decades of experience in compassionate representation of clients in consumer product injury, mass tort, and class action law suits. For more information, please visit their Web site, or call (888) 9-ROT-LAW.


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