FDA Limits Drugmaker Liability in Label Revamp

FDA Limits Drugmaker Liability in Label Revamp

(January 18, 2006) -- U.S. health officials issued controversial language stating that federally approved drug labels pre-empt state liability laws as part of a revamp of the lengthy, hard-to-read instructions that come with medicines.

The Food and Drug Administration said it added the pre-emption of state laws to address drug makers' concerns that the streamlined summary of risks could increase their liability if patients alleged the warnings were inadequate.

Critics said the FDA was overstepping its authority in order to protect drug makers from lawsuits.

Dr. Scott Gottlieb, FDA deputy commissioner for scientific and medical affairs, said drug labels had become "cluttered with a lot of information that wasn't necessarily directly pertinent to patients and physicians ... labels were becoming disclaimers rather than important health tools."

The new format is aimed at helping doctors find important information quickly. The updated design adds a "highlights" section that summarizes the most important details about potential benefits and side effects, and a table of contents to help find more information.

In a preamble to the new rules for drug labels, the FDA said it believed its approved prescribing information "whether it be in the old or new format, preempts conflicting or contrary state law."

Gottlieb said the language was a restatement of a position the FDA had taken in state lawsuits against drug makers.

The Bush administration has favored steering litigants toward more stringent federal courts. In early 2005, President Bush signed into law a bill shifting most class-action lawsuits into federal courts.

Sen. Edward Kennedy, a Massachusetts Democrat, objected to the FDA move.

"It's a typical abuse by the Bush administration - take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry," Kennedy said.

The National Conference of State Legislatures called the language "a thinly veiled attempt on the part of FDA to confer upon itself authority it does not have by statute and does not have by way of judicial ruling."

The Pharmaceutical Research and Manufacturers of America, a drug industry group, said it was important that companies' efforts to explain drug risks and benefits "not be undone by 50 different sets of product liability laws" in various states, particularly after a detailed review by FDA experts.

The new format for prescription drug labels was first proposed in 2000, without the contentious pre-emption measure. (Additional reporting by Susan Heavey)

Last updated: 1/06

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FDA Limits Drugmaker Liability in Label Revamp