FDA going absolutely nuclear on this Citizen Petition... holy moly.

Not only does it reject the petition, but says that it's so egregious that it's referring it to the FTC as a potential anti-competitive action.

regulations.gov/document/FDA-2… Basically the regulatory equivalent of this GIF:

A few thoughts on today's FDA news on J&J:

An FDA regulatory decision isn't a binary -- a vaccine isn't either available or not available.

Rather, FDA's reviews are meant to support intelligent, informed decision making by patients and care providers.

More ...👇 For example, imagine you had some basic questions like:
- If I take this vaccine, what behavior can I engage in?
- How much protection does this vaccine offer?
- What are the risks I assume when being vaccinated, personally?

Alright, folks. You may have seen that the FDA was in a fight with distilleries last week.

Let's unpack what happened, why it happened, and why it's now resulting in some extremely unusual behavior by HHS.

Thread below. Follow if you're interested. If you're like most people, you might have stumbled across a few news items in this past week talking about how the big-bad-FDA was deciding to screw over distilleries with a $14,060 fee.

reason.com/2020/12/30/whe…

Ok, now that we have the actual text of the EUA, let's start digging in and answering some of the questions I asked earlier.

My questions:

https://twitter.com/AlecGaffney/status/1337562953403539456?s=20

The authorization letter to Pfizer: fda.gov/media/144412/d…

Healthcare fact sheet: fda.gov/media/144413/d… First, FDA decided to allow the vaccine to be used in persons 16 and older.

That was a huge point of contention in the trial due to a relative lack of data in 16-17 years olds relative to others.

4 people in the FDA AdComm meeting yesterday rejected over this.

So I guess while we're all waiting around for FDA's vaccine authorization notice, a few things that I'll be looking for in the notice:

- Which populations are covered under the indication? (Likely persons 16 y/o+)
- Which populations aren't? (Young children, pregnant persons?) - Are there any noted side effects or warnings, like for Bells Palsy, Anaphylaxis or Appendicitis?
- Does FDA's label comport with the label of Health Canada or the UK's MHRA?
- What's the vaccine called? BNT162b2, or the Pfizer-BNT COVID-19 Vaccine?

Is FDA too slow to act? Consider this:

Pfizer submitted an Emergency Use Authorization for its vaccine on November 20th.

If authorized today, the 10th, that would make it FDA's review was twice as fast as any new product* the agency has ever approved. * Defined as a New Molecular Entity, or a novel product for which approval has never before been granted.

There are obviously faster approvals for generics, follow-on indications, etc.

It is difficult to overstate just how unusual a statement like this is.

FDA normally doesn't even acknowledge the *existence* of a product that isn't yet approved. Here, it's explicitly stating that authorization is assured and due extremely soon.

More thoughts below 👇

https://twitter.com/US_FDA/status/1337368688454983681

Let's unpack another key concept, too:

For FDA, a PRODUCT is never "approved." Rather, an INDICATION for a product is approved.

That's why there's a delay here. FDA and others know (now) the product is safe and effective.

The question is: For who, exactly?

Like many of my industry colleagues, I'll be tweeting out some observations from today's big vaccine advisory committee meeting.

Not everything I see, but "Hmm, that was interesting..."-type stuff.

I'll try to thread my tweets to make them easier to read. First, let's remember what's at stake: Authorization (not approval!).

An authorization decision isn't a binary (authorize/not authorize).

What we're likely talking about is authorization *and* the extent of any warnings, controls, labeling, contraindications, and monitoring.

The UK authorization of the COVID-19 vaccine means we have access to a product label.

Two observations that I think media folks in the US should keep an eye on:

- The vaccine causes plenty of short-term side effects
- People aren't protected until 7 days after 2nd dose The label: assets.publishing.service.gov.uk/government/upl…

Healthcare provider label: assets.publishing.service.gov.uk/government/upl…

Hello and welcome to my pedantic TED talk on FDA terminology.

Here's a shocking-sounding claim: A vaccine for COVID-19 won't be "approved"!

Why? Because it will instead be "licensed."

More on this below, including some FDA history and trivia. 👇 So the reason is simple: Vaccines are submitted for FDA review under a Biologics License Application.

This is generally one of those "distinctions without a difference" that is so commonly forgotten about that even the FDA says "approved" when it licenses many vaccines.

Reading through FDA's vaccine guidance now. Will be Tweeting out a few observations.

fda.gov/media/139638/d… I know most folks will skip right by the manufacturing stuff, but there's a really interesting point in here. FDA says it won't necessarily do a physical inspection of vaccine production facilities prior to approval. It may instead make use of other means of inspection.

Alright, gather round folks, because it's time for another Twitter thread explaining one of the FDA's programs, why it matters, and why you're about to hear about it a lot.

This is going to be a must-read thread for every journalist writing about drugs, FDA & #COVID19. 👇 1/20 (If you want to skip this thread and go right to what my colleague Lily Rosenfield and I wrote on this subject, you can find our analysis here: agencyiq.com/as-therapies-f…)

But let's be real: It's late, you're bored and on Twitter, so the thread continues below. 2/20

Alright folks, I have a MASSIVE piece of analysis to share with y'all.

I dug up every FDA regulatory pathway I could think of, and put together a list of the 22 pathways I think could be used to help approve drugs & biologics for #COVID19:

agencyiq.com/the-twenty-two…

Thread 👇 Why would I put together this list?

Because as #COVID therapies start to go into clinical testing, there is a profound lack of information about how these products are actually reviewed or made available.

I put this together as a resource for anyone to easily learn more.