On Label, Off Label, No Label: Part 2

Series: Biologic Eye Drops and the FDA
Episode: June 9, 2022
Description: Explains on label, off label and “no label” prescribing of commercially manufactured eye drops.

0:00 Introduction

0:23 Are you a radical patient? (Understanding “on label” vs “off label” vs “no label”)

1:55 On-label example (Restasis); off-label example (Azasite); sensible expectations of drugs prescribed on-label or off-label.

3:53 Adverse events and on-label, off-label and off-off label prescribing

7:12 Why, when you go “radically NO label”, you abandon safety; biologic eye drops versus serum tears; the usual counter-argument

10:21 “I’ll abandon safety for hope”: How this might play out in an off-label versus no radical no label prescribing situation

13:11 Conclusion: Be smart not radical… hold out for a real drug label