FDA Letters Made Public Are Creating New Risks

By Louis Garguilo, Chief Editor, Outsourced Pharma

I once wrote – reluctantly – about The FDA 483 Heard Round The World. This was regarding a manufacturing/quality issue at a leading CDMO that went viral.

“Reluctantly” because any regulatory action can be treated as an overly broad conclusion placed on an entire organization, rather than a part of an ongoing process.

Certainly, when a recipient of an FDA warning letter takes the process too lightly—or continues to have issues – it should be news, and dealt with accordingly by the FDA, the industry, and the public.

At all times, though, there is also a necessary balancing, and the potential for damaging (mis)perceptions that should be kept in mind.

I rehash this because, as they say, here we go again.

As first reported in Endpoints by Zachary Brennan, we now have a pharma-backed "citizen petition" challenging the FDA over its new practice of publicly releasing selectively redacted Complete Response Letters (CRLs).

This time it’s a drug sponsor questioning the legality, statutory content, and frankly, wisdom in publicizing CRLs – perhaps without relevant context or thoughtful redactions.

The petition argues our "new" FDA may be disclosing information it is in fact required to protect. It explicitly frames the issue as concerning “black-letter federal law” protecting confidential commercial information. 

This ties directly to longstanding FDA confidentiality regulations (e.g., 21 CFR 314.430), which historically treated CRLs as nonpublic.

What we are looking at, then, is more than industry discomfort, but a potential statutory violation.

Less Is More, More Or Less

A less obtuse and more open FDA, yes. But CRLs have traditionally been considered and treated primarily as private communications based on sound reasoning.

These communications represent to a large degree a private dialogue, often complex and iterative between a drug sponsor and regulator, on how to (or how not to) move a drug forward.

Since late 2025, that dialogue has increasingly become public; hundreds of CRLs have now been released.

At times, some have been made public within hours of issue. It’s been reported that in at least one instance, employees learned of an FDA rejection online before internal communications could reach them.

In my earlier column, I wrote that “483s have a narrative,” and so do CRLs.

But what happens when sponsors and regulators know that much of what is said or even explored may soon become public? And when that narrative is revealed without full and important context? 

Our industry, already facing public skepticism, is now at risk of a steady drumbeat of overly negative headlines about the innovators and manufacturers developing and producing our medicines.

The point is that any setback or challenge can enter the media stream as a headline if the FDA does not handle CRLs with care. As one industry professional told me a while back on the 483 subject, “Once it’s out there, it doesn’t matter how nuanced it is. The narrative is already set.”

Negligent actors must be dealt with. CRLs and 483s do that effectively. The industry and public should be forewarned and advised. We should also be reminded drug innovators and manufacturers are already governed by disclosure laws and a slew of other regulations. 

Yet there is – now officially – a case being prosecuted regarding how to make drug creation and production safe from uncontextualized transparency and broad misconception.

What Is Being Disclosed

The citizen petition was filed by Covington & Burling, an American multinational law firm, on behalf of an unnamed biopharma company. It raises the specific concern that competitively sensitive information may be slipping through the cracks of public release.

Regulatory recommendations regarding intellectual property or company strategy, suggestions for alternative roadmaps or the receiving of guidance, in most business contexts would be considered part of a company’s strategic interaction with a government agency.

A huge risk arrives with that becoming public. For those of us focused on outsourcing, CRLs often include CMC-related observations. And as with 483s, those observations can quickly implicate external partners.

Proper redaction is critical, but if done poorly, leads to either significant misperceptions or, on the other hand, the leaking of trade secrets and implications that can encompass an entire development and manufacturing supply chain.

As one CMC advisor puts it, “You could have a very specific issue, in a very specific part of development, and suddenly it looks like a systemic failure across multiple parties.” 

The risks of FDA opacity are real. So are the risks of unfettered public disclosure. I bet most readers will say it’s the former that has presented the real concerns, and most all of us have called for a more open FDA.

Now we have it. On balance it is a highly positive development. Balance, though, is the key attribute.

Greater transparency improves industry learning and provides valuable and specific real-world studies. Moreover, it informs the public, which should instill a higher faith and trust in the institutions and companies that make up the drug industry.

Let’s see where this “citizen petition” (or a subsequent law suit) leads. Hopefully, we reach a solution where the FDA carries on with its attempts to reveal more, but does so in a calibrated way, so that risks to the industry and its businesses are mitigated, and the public trust in a safe drug supply is elevated.

Among other remedies, the petition itself calls for companies to be guaranteed the opportunity for input into redactions before release.

I think we could label that procedural due process.

I previously wrote we should resist turning regulatory observations into broad conclusions. Let's ensure we don’t flip regulatory communications into immediate public or industry denigrations.

Perhaps more than any time in our memory, the FDA today is being questioned and criticized.

Be that as it may.

I don't hesitate in the belief that here the FDA is acting in good faith – with the intent to increase transparency (as we’ve all hoped for); standardize how it responds and communicates; reinforce its own accountability; and positively affect the industry as it can as a regulatory body.

At the same time, kudos to a strong industry that pushes back where necessary.

As we struggle to reach a balance, we should all proceed with a keen sense of what brings opportunity and what brings risk from the FDA.