Democrats buoyed by support from trial lawyers were successful in inserting anti-preemption language in the compromise FDA Amendments Act passed by the Senate 9/20. The language, which is buried deep in the compromise bill (page 281), falls under the heading “Rule of Construction” and reads:

This paragraph shall not be construed to affect the responsibility of the responsible person or the holder of the approved application under section 505(j) to maintain its label in accordance with existing requirements, including subpart B of part 201 and sections 314.70 and 601.12 of title 21, Code of Federal Regulations (or any successor regulations).

This rule-of-construction statement essentially spells out drug sponsors’ responsibility to add or strengthen a contraindication, warning, precaution, or adverse reaction without first being required to do so by FDA, according to observers. It could be helpful in state tort failure-to-warn cases that recently have been met with preemption arguments asserted by defendants and FDA itself after the agency added such language in the preamble to its 2006 drug labeling rule. The legislative statement could also bolster plaintiff arguments that a product’s FDA-approved labeling is just the “floor” or minimum requirements as some have claimed. FDA and drug companies contend that the FDA-approved label is both a floor and a ceiling such that additional disclosures of risk information can expose a manufacturer to liability under the Food, Drug and Cosmetic Act if the additional statement is unsubstantiated or otherwise false or misleading.

At the time FDA issued its final drug labeling rule, former FDA deputy commissioner for medical and scientific affairs and now-resident fellow at the American Enterprise Institute Scott Gottlieb said the preemption language was necessary because labels had become so cluttered with information that they were becoming disclaimers. “We wanted to reclaim the labeling for patients and doctors and be sure they only contain scientifically vetted information,” he said at the time.

Writing in a 9/20 Wall Street Journal commentary, Gottleib warned that the FDA Amendments Act anti-preemption language would lead to state courts and juries “second-guessing” when companies, and FDA, should decide to issue new safety warnings. “The new regulations being passed as part of [FDA mendments Act] will also force more drug labeling changes that create their own opportunities for lawyers to pile on to the agency's findings. Now thanks to the Democrats' maneuvering, the legislation will help trial lawyers more easily cash in off those suits.”

Still the FDA Amendments Act language may not be as clear and unambiguous as trial lawyers had hoped for, and whether or not FDA regulations on labeling preempt state tort claims will likely be left for the courts to sort out.

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