FDA Position on Approval of Prescription Drug Labeling Under FDCA to Preempt Certain State Law Product Liability Claims

2006

The FDA issued a formal statement this year that is expected to strengthen arguments by drug manufacturers that state law failure to warn claims are preempted by federal labeling regulations. In January, 2006, the FDA promulgated a final rule that modified prescription drug label requirements. (See Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3922, et seq. (Jan. 24, 2006).) In the preamble to that rule, the FDA set forth six specific failure to warn claims that it considers preempted by federal labeling requirements:

• claims that a manufacturer failed to “put in Highlights or otherwise emphasize any information the substance of which appears anywhere in the labeling”;
• claims that in direct to consumer advertising a manufacturer failed to include “any information the substance of which appears anywhere in the labeling” where the manufacturer has “used Highlights consistently with FDA draft guidance regarding the ‘brief summary’” in the advertising;
• claims that a manufacturer failed “to include contraindications or warnings that are not supported by evidence that meets standards” set forth in the regulations regarding scientific proof of risk;
• claims that a manufacturer failed “to include a statement in labeling or in advertising, the substance of which had been proposed to FDA for inclusion in labeling, if that statement was not required by FDA at the time plaintiff claims” the warning should have been given unless the FDA has determined that material information relating to the proposed warning had been withheld from the FDA;
• claims that a manufacturer failed “to include in labeling or in advertising a statement the substance of which FDA has prohibited in labeling or advertising”; and
• claims that a manufacturer made “statements that FDA approved for inclusion in the drug’s label” unless the FDA has determined that material information relating to the statements had been withheld from the FDA.

The preamble implies that this list is not exhaustive but is, at a minimum, what the FDA considers preempted.  It also makes clear that preemption affects not only claims against manufacturers but also claims against health care professionals