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FDA to Allow Generics Makers More Ability to Change Label

Source: Dow Jones

Posted on 10 Jul 13 by Annie George

The Food and Drug Administration plans to issue a new rule by September that would allow generic-drug companies to make changes in their labeling, a step which could open the generic drug makers up to liability if their drugs injure patients.

Recent Supreme Court decisions have barred lawsuits against generic makers in large part because unlike the makers of the brand-name versions of drugs, generic companies are unable to change warnings and other information in labels.

The FDA's move was released in a government agenda of new rules being considered by federal agencies. The agenda said the revisions to FDA rules would "create parity" between makers of brand-name drugs and generics makers in terms of their ability to change drug labels.

FDA spokeswoman Sandy Walsh confirmed the planned rule change but said it was too early to know precisely how the new rule would be worded.

"We think this is a great first step toward making generic drugs safer by addressing generic drug labeling," said Sarah Rooney of the American Association for Justice, a group that represents plaintiffs' trial lawyers. She said the change would make generics and brand makers "equally responsible" for drug safety.

Critics of the court's rulings had said they created an anomalous situation in which people could sue a brand maker over an alleged label flaw but not a generics maker even if the two drugs were chemically identical.

Sen. Patrick Leahy (D., Vt.) hailed the FDA move. "A consumer should not have her rights foreclosed simply because she takes the generic version of a prescription drug," Mr. Leahy said. "I welcome this first step by the Food and Drug Administration to address this troubling inconsistency in the law."

The Generic Pharmaceutical Association said it couldn't comment until it knows more about the FDA's plans.

The Supreme Court, in a 2009 case, permitted a suit in state court against a brand drug maker over allegations that a drug's warning label was inadequate. But a 2011 ruling by the court protected generics makers from similar lawsuits, reasoning the companies couldn't be sued because they didn't have the power to change the label's wording on adverse side effects.

Last month, the court reaffirmed the 2011 ruling in a similar case involving a New Hampshire woman who said she suffered severe injuries caused by an anti-inflammatory drug. The woman received severe burns over her body and is nearly blind.

In a 5-4 ruling, Justice Samuel Alito wrote for the court's conservative majority that sympathy for the plaintiff " does not relieve us of the responsibility of following the law."

He wrote that federal drug regulations pre-empted state product-liability laws and blocked the suit.