Generics Lobby Threatens Suit Over FDA Warning Labels Plan

Law360, New York (September 23, 2014, 6:39 PM EDT) -- The Generic Pharmaceutical Association on Tuesday promised to sue if the U.S. Food and Drug Administration finalizes a proposal that would expose generics makers to more personal injury litigation by letting them update their warning labels, urging regulators to instead adopt a compromise.

Ralph G. Neas, the association's CEO, made the vow during a call with reporters regarding efforts to dial back a proposed rule that would end a long-standing practice in which responsibility for revising warning labels falls to brand-name manufacturers.

“The regulatory branch would be changing the law by executive fiat,” Neas said. “We would be forced to go...

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