Perspectives on Cross Labeling

1. 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

2. Why is developing a cross labeling policy important? • Confusion may deter product development • Greater clarity may be more efficient

3. A note on terminology • Cross labeling • Mutually conforming labeling Is there any difference?

4. 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

5. 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

6. 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

7. Categories of Issues • Labeling issues • No ongoing relationship between manufacturers issues • Pathway issues

8. 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

9. 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

10. 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

11. More Pathway Issues All those legal issues: Bumps on the road….

12. 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

13. Why is this so challenging? • Company A’s proprietary interests • FDA’s core beliefs about labeling • Company B’s commitment to Product B

14. 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?

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