More from @RxRegA

Jessica Adams

@RxRegA

Jun 26

Each discussion Q could be posed as a vote, to make the Jun 28 VRBPAC more productive. Instead FDA goes w/ a single, overly broad voting Q that seems primed for a unanimous vote. VRBPAC politics are disheartening. The goal isn't a unanimous vote but a poll and the clearest input.

Yes, members will still get to speak in discussion, but w/out a vote for each, the outcome is less likely covered fully by most of media, who hasn't well been messaging their nuanced input.
This said, unfortunately my life is pulling me away from covering this mtg to much degree.

I can always do a post-mortem later. It's just a struggle to make this next meeting a priority with what else is going on for me right now.

Read 4 tweets

Jessica Adams

@RxRegA

Jun 24

https://twitter.com/DrCaliff_FDA/status/1540443007593349120

“Misinformation & disinformation are now arguably the leading causes of death in America” This again?

https://twitter.com/DrCaliff_FDA/status/1540443007593349120

I want FDA+gov to compile & release iron-clad info backed by detailed data & sourcing that stand on its own. I don’t want them policing info by Americans whose right is to take a view. Untruths are best counteracted by high-quality, truthful, transparent info which is enough work

Don’t pile on new work that FDA isn’t equipped for. Don’t have them delving into political issues when people are concerned about political influence on FDA.
Btw iron-clad info can look like conclusions from imperfect data sets that describes the limitations & weaknesses inherent

Read 4 tweets

Jessica Adams

@RxRegA

Jun 24

Maybe I'll start a podcast called "What the F...DA?" which questions the FDA, an agency I mostly still respect, but for whom I have some questions.

Episode 1: Where are the F-ing briefing documents, F...DA? You're not always hitting the 2-day-before-meeting mark. fda.gov/advisory-commi…

https://twitter.com/berkeleyjr/status/1540410067375235073

The FDA briefing documents that ideally would’ve posted at 8:30 a.m. today will reportedly post late tonight or tomorrow. #WhatTheFDA?

https://twitter.com/berkeleyjr/status/1540410067375235073

Read 5 tweets

Jessica Adams

@RxRegA

Feb 2

Woah, looks like a few key #VRBPAC members who've been participating in past FDA AdCom meetings for COVID vaccines had terms that ended yesterday: Kurilla, Meissner, & Offit. These are standouts. There may be more members, but I haven't had a chance to compare all w/ ended terms.

However, I believe that they can be brought in to serve as temporary members. The panel makeup will be interesting to follow. Here's the current standing #VRBPAC roster: fda.gov/advisory-commi…

Monto (the prior VRBPAC Chair) isn't on the standing roster page anymore. I wonder when his term expired?

Read 4 tweets

Jessica Adams

@RxRegA

Jan 31

@US_FDA

Waiting for @US_FDA to fix their SpikeVax webpage now that it’s fully approved. Goes to error fda.gov/vaccines-blood… Approval PR fda.gov/news-events/pr… $mrna