The FDA and Autologous Serum Tears

Why are autologous serum tears (AST) legal and biologic eye drops (BED) aren’t?

0:00 Introduction, the history of the snail, and disclaimers

1:28 How a compounding pharmacy makes autologous serum tears

2:24 How a drug manufacturer makes biologic eye drops

3:08 AST & BED: Signaling proteins - growth factors; cytokines; chemokines and their very brief life cycles

See also video presentation “Sludge”

4:08 DrB’s summertime reading: the Code of Federal Regulations

See also video presentations “FDA Regulation of Biologic Eye Drops Part 1 / Part 2”

4:17 Enormous legal difference #1 between autologous serum tears and biologic eye drops (your germs, your business)

5:29 Enormous legal difference #2 between AST and BED (interstate commerce)

6:55 How the FDA and the Surgeon General would feel about you using your own blood to make serum tears that you use yourself, and why

7:18 Why the FDA and the Surgeon General would feel very differently about BED package inserts (e.g. “doesn’t work, might infect you” - hmmm)

See also video presentations “On Label, Off Label, or No Label Part 1 / Part 2”

9:09 Summary table 9 - AST vs BED

Don’t forget to see video presentation “Sludge”

10:41 Attempted rebuttal #1: BED are like amniotic membrane grafts

11:33 Attempted rebuttal #2: It’s a tissue, not a drug

Don’t forget to see video presentations “FDA Regulation of Biologic Eye Drops Part 1 / Part 2”

14:27 “But my doctor say’s it’s fine” (things your doctor may not understand; things your doctor may believe)

15:52 “I want to use biologic eye drops” - it is important that this decision is an informed decision - education is the primary mission of biologiceyedrops.org

16:52 Be smart. If you won’t rub it on your face, don’t drip it in your eyes.