FDA Final Rule: Prescription Drug Labeling

The Food and Drug Administration issued a final rule on drug product labeling last week (January 24).  In the preamble, the agency goes to great lengths to assert that its decisions on what needs to be included in drug labels preempts state law:  "FDA believes that under existing preemption principles, FDA approval of labeling under the act, whether it be in the old or new format, preempts conflicting or contrary State law."  At 71 Fed. Reg. 3934 and following, it goes into detail about arguments made in past amicus briefs by the federal Justice Department.  It argues that "State law requirements can undermine safe and effective use" of drugs, by creating pressure on drug manufacturers to provide information on "speculative risks" and accordingly to "limit physician appreciation of potentially far more significant contraindications and side effects." 

The FDA asserts that "at least the following claims would be preempted by its regulation of prescription drug labeling:  (1) Claims that a drug sponsor breached an obligation to warn by failing to put in Highlights or otherwise emphasize any information the substance of which appears anywhere in the labeling; (2) claims that a drug sponsor breached an obligation to warn by failing to include in an advertisement any information the substance of which appears anywhere in the labeling, in those cases where a drug's sponsor had used Highlights consistent with FDA draft guidance regarding the "brief summary" in direct-to-consumer advertising... (3) claims that a sponsor breached an obligation to warn by failing to include contraindications or warnings that are not supported by evidence that meets the standards set forth in this rule including S 201.57(c)(5) (requiring that contraindications reflect "[k]nown hazards and not theoretical possibilities") and (c)(7); (4) claims that a drug sponsor breached an obligation to warn by failing to include a 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 sponsor had an obligation to warn (unless FDA has made a finding that the sponsor withheld material information relating to the proposed warning before plaintiff claims the sponosr had the obligation to warn); (5) claims that a drug sponsor breached an obligation to warn by failing to include in labeling or in advertising a statement the substance of which FDA has prohibited in labeling or advertising; and (6) claims that a drug's sponsor breached an obligation to plaintiff by making statements that FDA approved for inclusion in the drug's label (unless FDA has made a finding that the sponsor withheld material information relating to the statement).

The FDA also asserts that "Preemption would include not only claims against manufactuers as described above, but also against health care practitioners for claims related to dissemination of risk information to patients beyond what is included in the labeling).

The FDA also stated that there was no need to apply the interpretative strategies described in Executive Order 13132 on Federalism (which requires agencies to "construe... a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute") since the agency had determined that federal law "preempts State law because the exercise of State authority conflicts with the exercise of Federal authority under that statute."

This sweeping approach has drawn concern from the National Conference of State Legislatures which views the action as a usurpation of Congressional and state prereogatives.  According to the Washington Post the FDA recognizes that the regulation's preamble "does not have the weight of law or formal regulation, [but] they hope state judges will accept their position."

State courts will at the least have to become even more informed about the nuances of federal preemption doctrine.