A Proposal for Higher Costs & More Lawsuits

November 11, 2013

On Friday, the Food and Drug Administration released a draft regulation that would allow generic drug makers to change warning labels on their products the Wall Street Journal reports.

ILR president Lisa Rickard warned that the rule change could lead to mega lawsuits against the industry:

“The FDA’s proposal writes a prescription for mega lawsuits against generic drug makers by plaintiffs’ lawyers alleging that generic labels are somehow inadequate.

“The proposed change would make warning labels inconsistent and confusing for consumers. It would also force generic manufacturers to conduct costly research and create a structure to assess their labels, which would in turn lead to higher drug costs.

“It is unfortunate that the FDA is considering a change that could drive up the cost of generic drugs, perhaps by billions of dollars.”

Generic drug makers account for nearly 84% of the prescription drugs by volume in the US, and the change could drive up costs for a wide swath of consumers.

The proposal now enters a 60-day comment period for the public to weigh in on the rule.

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