Generic Drug Regulations Have Industry, Consumer Groups at Odds

Published on April 16, 2015 by Sandy Liebhard

Consumer advocates and the pharmaceutical industry are engaged in a battle over the U.S. Food & Drug Administration’s (FDA) regulation of generic drug labels. The outcome of this fight has the potential to impact consumers everywhere, who are currently denied the right to bring state failure-to-warn claims against generic drug manufacturers when their products cause harm.

Generic Drug Labeling

Currently, the FDA requires that generic medications carry the same warning labels as their name-brand counterparts. As such, generic manufacturers can’t update their product labels unless the FDA orders a change, even if new side effect information becomes known to them. By contrast, name-brand drug manufacturers can alter their labels with new safety warnings whenever they become aware of such data.

In 2011, the U.S. Supreme Court ruled in Pliva vs. Mensing that state failure-to-warn claims were preempted in drug injury cases involving generics. Basically, the Court’s majority reasoned that generic drug manufacturers should not be held responsible for failure to warn because they have no control over their products’ labels.

What does this mean for consumers? Well, when a person suffers an unexpected complication from a prescription medication like Risperdal, they may be able to file a lawsuit against Johnson & Johnson and its Janssen Pharmaceuticals unit over their alleged failure to provide warnings about that side effect. But if someone else sustains the very same injury from a generic version of risperidone, they currently have no legal recourse to obtain compensation from the generic drug manufacturer.

Consumer groups like Public Citizen and the American Association of Justice’s Take Justice Back Campaign say this situation gives generic drug companies a “free pass” on safety.

FDA Mulling Changes to Generic Drug Rules

In 2013, the FDA did propose a new rule that would allow generic drug makers to update their labels on their own. But Big Pharma has been exerting significant pressure on the agency to prevent it from adopting the rule. The industry recently made a counterproposal, which prompted the FDA to reopen the comment period on the new regulation, and convene a public meeting on the matter last month.

During the March 27th meeting, representatives for pharmaceutical companies insisted that disaster would strike if the FDA’s proposed rule goes into effect. But consumer groups say that’s nonsense.

“All it does is reset the calendar back to 2011 when they could be held liable for ‘failure to warn’ and they had to be insured for that,” Michael Carome, MD, director of Public Citizen’s Health Research Group, asserted.

Dr. Carome also added that restoring consumers’ right to sue for injuries caused by generic drugs will provide the industry with a powerful incentive “to promptly update their labels to monitor for new safety information and ultimately to protect patients.”

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