United States: FDA Proposes Drug Safety Warning Rule That May Eliminate Preemption Defenses In Some Failure-To-Warn Cases

Last Updated: November 19 2013
Article by Jonathan Berman, José A. Isasi II and Colleen Heisey

In a highly anticipated move, the U.S. Food and Drug Administration ("FDA") has proposed amending its regulations to permit abbreviated new drug application holders (generics) to independently revise product labeling based on newly acquired safety information without prior Agency approval. The proposed rule reacts to, and may undermine, U.S. Supreme Court decisions limiting generic drug company liability.

In Pliva, Inc. v. Mensing, 131 S.Ct. 2567 (2011), the Supreme Court ruled that generic drug companies are often immune from tort liability in failure-to-warn cases. Federal drug regulations generally prohibit generic drug manufacturers from unilaterally altering drug warnings, even where a state tort regime would impose liability for failure to provide a more robust warning. Where complying with both federal and state law is impossible, the Court reasoned, state tort claims are preempted. However, on November 8, 2013, FDA announced a proposed rule (which was formally published on November 13) permitting generic companies to add or strengthen warnings to their product labels without prior approval. FDA anticipates—and apparently intends—that plaintiffs will argue that the new rule eliminates the underpinnings of Pliva and the preemption defense for generic drug manufacturers.

FDA maintains tight control over drug labeling. Generally, FDA must approve all parts of a drug label before the drug can be marketed, and a manufacturer cannot make significant changes without obtaining FDA's prior approval. One exception is that brand name manufacturers can add safety warnings to their labels through a "changes being effected" ("CBE") supplement—meaning that qualifying safety changes can be made to a label without prior Agency approval as long as FDA is given notice when the label is changed. FDA will then review the label change, and it has the power to approve the change, reject it, or demand modifications. The Supreme Court has held that this ability to add warnings through the CBE process permits manufacturers of brand-name drugs to comply both with federal labeling regulations and state tort obligations. Thus, notwithstanding FDA's pervasive control over drug labels, preemption is in many circumstances not a defense against a state-law claim that a brand-name drug's label should have been stronger than the FDA-approved language. See Wyeth v. Levine, 555 U.S. 555 (2009).

The rules are different, however, for manufacturers of generic drugs. Because drugs that are essentially equivalent should all carry the same instructions and warnings, generic drugs are required to bear labels that are substantively identical to the labels of the equivalent brand-name drugs. Furthermore (although there is some ambiguity in the matter), the prevailing view is that the rule requiring uniformity prohibits the generic manufacturers from enhancing their products' safety warnings. This lack of flexibility has shielded generic companies against failure-to-warn claims. A generic manufacturer cannot be held liable for failing to provide a sufficient warning where doing so would violate the federal mandate requiring uniform labeling. See Pliva; accord Mutual Pharmaceutical Co., Inc. v. Bartlett, 570 U.S. – (2013) (following Pliva, and finding a design-defect claim to be preempted).

FDA's proposed rule would create an exception to the rule mandating label uniformity among equivalent drugs. If this rule is finalized, generic companies, like brand-name manufacturers, will be allowed to use the "CBE" process to strengthen safety warnings without prior FDA approval. The proposed rule also provides technical details regarding when it is appropriate to change a label, what notifications the generic companies must provide to FDA and the brand-name manufacturer, and what steps FDA will take to review the label change and restore uniformity among all equivalent products. (Essentially, FDA will decide what warnings are appropriate and will either reject the generic company's change or mandate that all manufacturers provide new labeling.)

FDA is well aware of the interplay between its "CBE" regulations and how preemption defenses have fared at the Supreme Court. FDA's description of the new rule in the Federal Register summarizes the Court's recent preemption decisions and notes a citizen petition that sought a rule change that would neutralize Pliva's holding. FDA expresses the view that Pliva "alters the incentives for generic drug manufacturers to comply with current requirements to conduct robust postmarketing surveillance, evaluation, and reporting, and to ensure that the labeling for their drugs is accurate and up-to-date." The new rule thus appears to be motivated, at least in part, by FDA's desire to strip away the preemption defense "to ensure that generic drug companies actively participate with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling...." FDA interprets Pliva as allowing FDA to "extend the CBE-0 supplement process" in the manner set out in the proposed rule.

FDA will accept comments on the proposed rule until January 13, 2014. FDA intends the rule to go into effect 30 days after the Federal Register publishes the final rule.

For more details of the Pliva case and the law of preemption in the context of drugs and other FDA-regulated products, see "Pliva v. Mensing: The Supreme Court Resumes Its Trend of Recognizing the Preemption of Claims Involving FDA-Regulated Products," Jones Day Practice Perspectives: Product Liability & Tort Litigation.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Jonathan Berman
Colleen Heisey
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