Many of you know I'm a stickler for using the correct language to describe FDA actions.

In a new analysis out today, me and @aaronbadida discovered major discrepancies used by many companies to describe a common FDA activity in their PR and investor letters.

Thread below

Some of you may already know some critical (or not critical) differences in FDA terminology.

A product for emergency use is authorized, not approved.
A premarket notification is cleared, not approved.
A biologic is licensed, not approved.

But what about a clinical trial?

First, some quick regulatory background here.

When a company wants to start a trial, it files an Investigational New Drug (IND) application with FDA.

This application spells out what it wants to study, how it will study it, and how it will protect patients.

The FDA will then review that IND application, and it can do three things:

- Issue a "clinical hold" on the investigation (i.e., don't proceed with the trial)
- Do nothing, in which case the IND may proceed after 30 days
- Notify the company that the IND may proceed w/in 30 days

Notably, FDA's language doesn't say it "approves" an IND.

Its guidance says it comes to a finding that "it is safe to proceed with the clinical trial."

Its regulations indicate than an IND "may begin" or is "safe to proceed."

Ok, enough history. Why is this interesting?

A review by AgencyIQ found that companies are wildly inconsistent (and in some cases bordering on prohibited activity) in their communications about their clinical trials.

A look at the language we found used in PR and investor statements:

"Wins FDA approval"
"Announces FDA allowance"
"Announced FDA clearance"
"Announces FDA acceptance"
"FDA Authorizes Phase 1 trial"
"Announces safe to proceed"

*very* few of the PR and investor statements we came across used the correct language to describe what FDA did.

Some used directionally-correct language ("Cleared").

Some used incorrect language ("approval") which could be misleading.

Naturally, we were interested in one very important question:

What did the FDA think about all this?

An FDA spokesperson told us: "Within the FDA, and as reflected in correspondence with industry, we don't typically talk about INDs as being approved or authorized. Rather, the studies are allowed to proceed."

The challenge, though, is that if companies are hyping up INDs in press statements, this could potentially border on misbranding.

Especially since INDs "often simply go into effect, rather than receive an explicit authorization,” FDA reminded us.

The use of the term "approved" for INDs is a bigger deal recently as more and more people are paying attention to clinical trial information, specifically as it relates to COVID-19.

If they see "approved," do they think it's a preliminary FDA approval?

(Based on some of the profoundly wrong news stories and blog posts I came across earlier this year, the answer to that last question is "yes")

So how *should* companies be referring to this activity?

FDA has preferred language here: "Allowed to proceed"

That language was probably the *least* used by companies that we found.

Now, I'm not aware of the FDA actually taking action on this issue to date (give me a yell if you know of some cases)

Companies should probably be more concerned about being sued for material misrepresentations of regulatory actions by law firms or investors.

Anyways, that's the Twitter version of our piece.

AgencyIQ subscribers can get our full, extensive analysis (including links, full quotes from FDA, examples and regulatory citations) here: https://fda.agencyiq.com/article/00000176-6962-df7e-a37f-fff3dfc60000

The bottom line: Regulatory language matters, and companies should be aware of how they're describing important activities and actions.