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Slide

Wyeth v. Levine: What Does It
Mean for Risk Management and
Risk Communication?

Geoffrey Levitt
Chief Regulatory Counsel
Wyeth

n Summary of Levine
n The “Newly Acquired Information” Standard
n FDA Interactions
n CBE/sNDA Practices
The Levine Decision: Summary of Key
Elements

n Patient received IV push injection of phenergan to treat nausea
associated with other meds used to treat a migraine headache;
drug inadvertently went into an artery, patient developed
gangrene and ultimately lost her right hand and forearm

n Intra-arterial injection explicitly contraindicated
n IV push injection carried warning:
INADVERTENT INTRA-ATERIAL INJECTION CAN RESULT IN
GANGRENE OF THE AFECTED EXTREMITY
n Question before the Supreme Court: did FDA’s approval of the
phenergan label, including portions of that label that addressed
risks of intravenous/intra-arterial administration, preclude or
“preempt” a state law claim that the warning of this health risk
was inadequate as a matter of state product liability law?

The Levine Decision: Summary of Key
Elements

n Main arguments supporting preemption were “impossibility” and
“frustration” (aka “objects and purposes”)
n Supreme Court: Wyeth could have analyzed pattern of
accumulating incidents of gangrene/amputation and unilaterally
strengthened warning consistent with “newly acquired
information” standard in CBE reg
n Absent clear evidence FDA would have rejected such a change,
not “impossible” for Wyeth to comply with both state and federal
standards
n FDCA and regulations plainly contemplate that manufacturer can
add or strengthen warnings to the extent that may be required
under state tort law, again absent clear evidence that FDA did
reject or would have rejected a particular warning statement;
therefore purpose of federal scheme not “frustrated” by
application of state law in this case
n A key take-away: Primary responsibility for maintaining the drug
label rests with the manufacturer, not FDA
“Newly Acquired Information”
n Trigger for CBE on safety labeling: “Newly acquired
information”:
Includes new analyses of previously submitted data if the analysis reveals “risks of a different type or greater severity or frequency than previously included in submissions to FDA” n But Levine holding strongly suggests that “new
analyses of previously submitted data” can include
review of AEs over time even if not different in type,
severity, or frequency than what label already reflects

n Does this indicate need to revisit approach to
cumulative review of AEs against existing label safety
information?
FDA Interactions
n How to establish that FDA considered and rejected or would have
rejected a particular warning statement
 FDA response to sNDA (including CBE) containing the statement  FDA scientific analysis rejecting basis for the statement  Public pronouncements by FDA opposing the statement  FDA action on citizen petition or other public submission proposing the statement  FDA issues specific class warnings, as in suicidality and antidepressants n Important to drive towards clear outcome in FDA interactions
 Did agency accept/reject/modify company safety language?  Adequate documentation essential, particularly where sNDA includes both safety n Important to document that underlying safety/AE information and
analyses were fully presented to FDA
Where To Now?
n The Drug Label In Context
n Whose Label Is It Anyway?
n Recent Developments: The Black Box

Source: http://fdasymposiumportal.com/assets/22/resources/levitt_2.pdf

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