Dems respond to FDA labeling proposal

WASHINGTON A group of House and Senate Democratic leaders complained yesterday about a proposal by the Food and Drug Administration that would limit when drug and device companies can add warnings to product labels, according to published reports.

The lawmakers are concerned that the new rule would result in fewer company-initiated warnings, more drawn out agency reviews and a longer delay in informing the public about potential drug or device dangers.

In a letter to FDA commissioner Andrew von Eschenbach, the lawmakers said current FDA rules give companies latitude to make needed changes. They said the new policy is restrictive and comes “at the expense of consumers and violates the mission of the FDA.”

“It is apparently designed to bolster the argument by companies defending against lawsuits that the regulations precluded them from adding contraindications, warnings, precautions and adverse reactions in the absence of FDA approval,” the lawmakers said.

They also said the FDA failed to identify a public health basis for the proposal, and asked the agency to provide them with a rationale.