Transcript Perspectives on Cross Labeling Suzanne O’Shea Product Jurisdiction Officer

Perspectives on Cross
Labeling
Suzanne O’Shea
Product Jurisdiction Officer
Office of Combination Products
FDA / DIA Combination Products and
Mutually Conforming Labeling Workshop
May 10, 2005
Why is developing a cross
labeling policy important?
• Confusion may deter product
development
• Greater clarity may be more
efficient
A note on terminology
• Cross labeling
• Mutually conforming labeling
Is there any difference?
Situations where cross
labeling issues arise
• Product B enhances safety or
effectiveness of Product A
• Product B uses Product A in a new
route of administration
More cross labeling
situations….
• Product B uses Product A for new
indication, new patient population
• Product B is a new component of an
already approved combination product
– a. originally approved under two applications
– b. originally approved under one application
And still more…
• Labeling of Product B and Product A
will be inconsistent in some way
• Labeling of Product B and Product A
will be contradictory
Categories of Issues
• Labeling issues
• No ongoing relationship between
manufacturers issues
• Pathway issues
Labeling Issues
• What happens if the labeling of
Product A and Product B don’t
match?
• End users could be confused.
• Labeling of Product B could get lost
• Co-packaged products
No Ongoing Relationship
• What happens if Company A and
Company B don’t talk to each
other?
•
•
•
•
Drug reformulation
Device redesign
Right of reference
Degrees of cooperation
Pathway Issues
• 21 CFR 3.2(e)(3) cross labeled
products are combination products
• Products intended for concurrent
use, but not cross labeled, are not
combination products
More Pathway Issues
All those legal issues:
Bumps on the road….
What’s NOT an issue
• A conclusion that cross labeling is
not required is not a data shortcut
• Differences in types of marketing
application
• Active consultation / collaboration
within FDA
Why is this so challenging?
• Company A’s proprietary interests
• FDA’s core beliefs about labeling
• Company B’s commitment to Product
B
Protect and Promote
the Public Health
• FDA prefers cooperation
• In the absence of cooperation, our goal
is to identify a pathway to enable
Company B to try to obtain approval of
Product B, while ensuring adequate
regulatory oversight.
• What should be FDA’s default position?
Help us invent the box.
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