The study also warned of cost growth from a loss of competition resulting from generic-drug makers withdrawing products from the market and from higher liability costs.
“This is a draconian departure from what the law has been for the past 30 years,” said the Generic Pharmaceutical Association's Neas. “There have been some settlements over the years, but there has been no final court decision that said generic manufacturers were liable for failure to warn. What Bartlett and Mensing did was reaffirm what was the law for the past 30 years.”
That's strongly disputed by Public Citizen's Carome, who said that until the Supreme Court's 2011 ruling in Mensing, generic-drug companies faced legal liability from failure-to-warn lawsuits and many cases were settled by the drugmakers after courts rejected their immunity claims. “The proposed rule would not create a new cost, but one borne and managed well by the industry consistently until June 2011,” Carome said.
Neas said generic-drug makers are urging the FDA to modify the proposed rule. Instead of allowing manufacturers to amend their labels, his group would prefer to leave the decisionmaking authority on generic labels with the FDA, but have the agency set up a process for expedited reviews of adverse-event reports.
“We don't want to kill the rule, we want to improve the rule,” he said.
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