WEBVTT

00:00:00.800 --> 00:00:01.980
Is FDA's guidance

00:00:01.980 --> 00:00:05.170
on sharing off-label
science actually in effect?

00:00:05.180 --> 00:00:07.570
The record says two different things.

00:00:08.350 --> 00:00:10.020
In January 2025,

00:00:10.450 --> 00:00:12.090
FDA published its guidance

00:00:12.090 --> 00:00:15.430
on scientific information
on unapproved uses.

00:00:15.430 --> 00:00:20.110
In 2025, OMB approved both of
its information collections.

00:00:20.110 --> 00:00:22.710
Yet in October 2026,

00:00:22.710 --> 00:00:26.380
FDA's page still says not
for current implementation.

00:00:27.510 --> 00:00:30.320
So treat the status as unresolved.

00:00:30.410 --> 00:00:32.760
Not dead, and not a safe harbor.

00:00:33.460 --> 00:00:37.900
Review each communication on
its own: the product, the use,

00:00:37.900 --> 00:00:40.430
the audience, and who asked for it.

00:00:41.010 --> 00:00:42.010
Three steps.

00:00:42.010 --> 00:00:45.960
One: give someone the job
of reconciling the status.

00:00:46.030 --> 00:00:50.280
Two: classify every
communication before release.

00:00:50.370 --> 00:00:53.390
Three: carry the review into every copy,

00:00:53.390 --> 00:00:55.820
from headlines to distributor pages.

00:00:56.560 --> 00:00:58.230
When the status is unclear,

00:00:58.280 --> 00:01:00.010
document the decision.