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Consumers have until April 27, 2015 to comment on a new rule for generic drug label changes proposed by the United States Food and Drug Admin­is­tration (FDA). The proposed rule would address the arbitrary inequality created four years ago by the U.S. Supreme Court’s decision in Pliva v. Mensing, a case in which the court deter­mined that patients injured or killed by dangerous generic drugs had no legal recourse when a manufac­turer failed to warn consumers about dangerous side effects. Pliva v. Mensing stood in stark contrast to the court’s 2009 decision in Wyeth v. Levine in which the court allowed patients injured or killed by dangerous name brand drugs to sue manufac­turers. The two rulings created two classes of consumers: those with rights, and those without. Under the current rule, manufac­turers of generic drugs are not required to update their warning labels even if they learn about new risks that were unknown at the time drugs were officially approved. The new rule would require generic manufac­turers to make necessary changes to their safety labels or be subject to liability. This would reestablish the rights of consumers when generic drug makers fail to warn about dangerous side effects.

Pharma­ceu­tical industry-backed econo­mists have suggested that exposing generic manufac­turers to new potential liability costs would increase the cost of healthcare spending by $4 billion annually, or about $1.16 per prescription. However, Frank Ackerman, Ph.D., a senior economist at the Massa­chu­setts Institute of Technology, calls the pro-industry econo­mists’ estimates a “quanti­tative fantasy” that “misun­der­stands the nature of cost-benefit analysis” and “exaggerates” the economic impact of the proposed rule change. “With every delay, more and more time passes in which patients are being put at risk,” said Michael Carome, M.D., director of Public Citizen’s Health Research Group.

Terrell Hogan personal injury and wrongful death law firm will continue to alert the public about this important issue as more infor­mation emerges.

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