FDA Makes Preemption Case Once And For All In Final Labeling Rule

The product liability preemption language in FDA's physician labeling rule applies to all drugs regardless of whether they are regulated by the final rule.

The new language stems from comments by industry that the changes in labeling format could become fodder for liability suits, especially against drugs approved before 2001 that will not be required to reformat their labeling.

"These comments expressed concern that labeling in the old format might be characterized by plaintiffs as inferior to labeling in the new format and, as a result, could be used as evidence that a manufacturer did not provide adequate warnings," FDA said.

Manufacturers asked FDA to present its stance that the agency maintains the sole regulatory discretion to determine the content of product labeling which preempts many product liability claims (¹ (Also see "Rx Label Format Changes Should Be Phased In Without "Highlights" - PhRMA" - Pink Sheet, 9 Jul, 2001.), p. 22).

"FDA believes that under existing preemption principles, FDA approval of labeling...whether it be in the old or new format, preempts conflicting or contrary State law," the ² preamble of the "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products" rule states.

FDA has had mixed success with the amicus briefs it has filed supporting its policy of preemption in several state product liability cases.

"In some of these cases, the court determined that the state law claim could not proceed, on the ground that the claim was preempted by federal law, or was not properly before the court by operation of the doctrine of primary jurisdiction," the rule states. "In some cases, however, the court has permitted the claim to proceed."

The presentation of FDA's preemption position in the physician labeling rule will likely serve as a one-size-fits-all amicus brief for product liability cases.

The legal framework provided in the labeling rule will alleviate the need for FDA to intervene in every case where state action is perceived to conflict with the agency's mandate.

Because decisions about whether a product liability claim is preempted by FDA's federal authority will be decided case-by-case at the court level, the agency undoubtedly hopes that its argument - that the integrity of product labeling is essential to FDA's regulatory function - will be persuasive.

"It will be up to the individual judges, but if they follow our policy advice, then the court cases will turn on the question of whether or not information was properly disclosed to the FDA, not whether it was included in the product label," FDA said.

The labeling rule enumerates six product liability claims that the agency expects to be preempted by its regulation of drug labeling (see chart: " ³ The Claim Game ").

FDA acknowledged situations in which the labeling rule would not preempt state law. "The Supreme Court has held that certain state law requirements that parallel FDA requirements may not be preempted," the rule states.

For example, a state law that assesses damages for violation of FDA requirements "does not impose an additional requirement upon...manufacturers but 'merely provides another reason for manufacturers to comply with federal law.'"

The original proposed version of the labeling rule - first proposed in December 2000 - did not claim to preempt state laws.

"FDA has determined that this proposed rule does not contain policies that have federalism implications or preempt state law," the ⁴ draft rule states.

While preemption has been a long-standing issue for the agency, FDA's assertion of authority attracted considerable attention under former agency Chief Counsel Dan Troy, now with Sidley Austin Brown & Wood (⁵ (Also see "FDA Chief Counsel Troy Resigns; Agency Says It Will Still Support Preemption" - Pink Sheet, 22 Nov, 2004.), p. 15).

The insertion of FDA's preemption claim has drawn criticism from some Congressional Democrats who for view the language as a handout to the pharmaceutical industry helping shield them from legitimate product liability.

The National Conference of State Legislatures also criticized the labeling rule for trying to exert unsupported federal power. "This attempt to insert preemption language is 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," NCSL said.

While FDA feels its preemption authority is well established in case law, an "FDA defense" clause has been a prominent component of many pieces of tort reform legislation proposed in Congress over the years.

Although tort reform bills have not been successful, product liability protections were provided for bioterror products under a recently signed appropriations bill (⁶ (Also see "Liability Protections For Pandemic Vaccine Makers Provided In Spending Law" - Pink Sheet, 2 Jan, 2006.), p. 27).

The long-delayed labeling rule, which goes into effect June 30, 2006, is built around a new highlights section at the top of labeling.

Among the documents released in conjunction with the final rule is a draft guidance on the content and format of the warnings and contraindications sections - parts of labeling that are often critical to many product liability suits (see ⁷ (Also see "Boxed Warnings To Be Considered For Drugs With Risk Unique To Class" - Pink Sheet, 23 Jan, 2006.)).