Pre-Emption Battle Looms In Supreme Court As FDA Finalizes Labeling Rule

FDA's final rule on sponsors' obligations to update their labels alters the definition of "newly acquired information" from the proposed rule while leaving the remainder intact. The change could be a boon to industry, but a slap to Democrats who had called for the rule's withdrawal.

The ¹ final rule on "Supplemental Applications for Proposing Labeling Changes for Approved Drugs, Biologics and Medical Devices" published Aug. 22 in the Federal Register noted the definition of "newly acquired information" has been revised to clarify that data can be "derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data."

The January 2008 proposed rule suggested that data could be derived only from reports of adverse events (² (Also see "FDA Preemption: Proposed Labeling Rule Draws Opposition From All Sides" - Pink Sheet, 4 Feb, 2008.), p. 10).

In the final rule, FDA defines a narrow set of circumstances when companies can revise product labeling without prior agency approval. The rule has angered many trial lawyers and members of Congress who say it reduces sponsors' legal exposure in product liability cases (³ (Also see "Supreme Court Ties On FDA Pre-Emption; Congress Seeks To Resolve Issue" - Pink Sheet, 10 Mar, 2008.), p. 8).

The timing of the final rule - which will take effect Sept. 22 - is fortuitous for industry because it is early enough to use in a case, Wyeth v. Levine, the Supreme Court is scheduled to hear Nov. 3, and it falls well outside the 60-day window of regulatory latency that could allow an incoming administration to reverse it.

While the rule is not strictly about pre-emption - the concept that FDA's authority over the safety of medical products trumps any standards that states might set - it could help arguments that the agency gives sponsors limited wiggle room to act on safety issues on their own, emphasizing the potential conflict between state and federal authority.

The Supreme Court will take up the preemption issue for drugs when it hears Wyeth v. Levine, and a decision in earlier device-related cases suggests the court could rule against the plaintiffs bar and in favor of industry (⁴ (Also see "FDA Pre-Emption Wins On Appeal" - Pink Sheet, 14 Apr, 2008.), p. 9).

Legislation already has been introduced in Congress to overturn that ruling, and a High Court decision for Wyeth probably will energize backers of the bill. Some members of Congress already have expressed concern about the FDA labeling regulation, stating in a letter that the rule would "protect companies ... from being held liable for marketing products they know are unsafe."

Clarifies Agency Practices

FDA says the rule "does not undermine a sponsor's responsibility to maintain its label," but clarifies the "longstanding practice of requiring that sponsors must have sufficient evidence that the standards are met."

"This final rule does not take away a sponsor's obligation to maintain its labeling under federal law under appropriate circumstances," the agency said, but rather is clarifying a sponsor's responsibilities and making the "text of the regulations match FDA's practice" for supplemental submissions regarding "changes being effected."

The agency also defended its stance on pre-emption, noting that Congress "expressly acknowledged that FDA's regulations are not static," and the agency "does not believe that the absence of an express pre-emption provision with respect to drugs affects the application of the doctrine of implied pre-emption."

Consumer advocacy groups, law firms, pharmaceutical companies and members of Congress submitted 20 comments on the proposed rule, addressing issues including the relationship between "changes being effected" supplements and Risk Evaluation and Mitigation Strategies.

Comments also addressed the impact on sponsors' ability to warn consumers and whether a sponsor retains the responsibility to maintain its label.

Under the FDA Amendments Act, the agency may require a REMS if necessary to ensure the benefits of a drug outweigh the risks. Accordingly, the rule says "if the labeling for a drug describes an element of an approved REMS, the sponsor must receive prior approval of any labeling changes that would necessitate a change to the sponsor's REMS."

However, the rule continues, "if the newly acquired information is related to the concern leading to a REMS but the proposed change to labeling could be made without requiring a modification of the REMS, the approved labeling for the product could be strengthened without prior approval."

- Becky Jungbauer ([email protected])