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.
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