The Erosion of the FDA Firewall

Last week, the FDA told Moderna it would not review its new flu shot.

Days later — after Moderna lobbyists escalated concerns to the White House — the agency reversed course and agreed to review it.

The White House denies involvement. The FDA insists decisions remain grounded in science. That may very well be true.

But that sequence — decision, escalation, reversal — didn’t sit right with me.

Not because I think a dangerous vaccine is about to hit the market.
Or because I believe FDA scientists have suddenly abandoned their oath.
And not because I think every approval is now corrupt.

But because it revealed something far more consequential:

We can no longer assume that FDA approval means a drug was evaluated in a vacuum, insulated from political leverage.

As a pharmacist, that assumption is foundational to my profession. It is also the bedrock of the health system that all of you rely on.

And it is eroding.

When I was trained, the FDA was the referee.

Imperfect, yes. Underfunded, certainly. But structurally insulated. Drug approval decisions were made on the facts, and the facts only.

Companies could argue over trial design. They could debate endpoints. They could challenge labeling language.

What they could not do — at least in theory — was appeal regulatory posture to the White House.

That boundary is softening.

A recent STAT News investigation revealed that lobbyists now openly discuss whether they can “influence the process.” Political firms tied to the administration have become part of Big Pharma regulatory strategy. Congressional inquiries into specific drug applications have become, in one FDA official’s words, “a pretty frequent drumbeat.”

None of this proves a drug was improperly approved.

But it proves something else:

Political escalation is now considered a rational strategy.

That’s new.

And that matters.

The Moderna episode got my attention. The broader pattern is what concerns me.

Under the current administration, we’ve seen expedited review timelines offered in exchange for policy concessions.

For example:

Let me be clear about something that may surprise you:

I am not inherently opposed to faster drug approvals.

If a life-changing medication can safely reach patients sooner, that is fantastic. If companies are willing to lower prices in exchange for operational efficiency, that can be good public policy.

The issue arises when regulatory speed becomes political currency.

Drug review timelines exist for a reason. They allow for:

When speed is granted as part of a broader political negotiation, it ceases to be purely scientific.

It becomes transactional.

And once regulatory tempo is negotiable, the integrity of the process is no longer guaranteed by structure alone.

Do I believe career FDA scientists are acting in good faith?

Yes — at least the ones who remain.

But the number of career scientists has dwindled. Many have left voluntarily. Others have been pushed out. Morale inside the agency has cratered. The departures have been so numerous that outlets like STAT have dedicated coverage tracking the exodus.

At the same time, power has shifted toward political appointees. Look no further than RFK as Exhibit A.

You do not need cartoonish corruption to alter institutional behavior. You only need:

I have written before about how fragile oversight already is. The FDA inspects only a fraction of foreign manufacturing facilities. It relies on voluntary compliance more than most Americans realize.

That system was already stretched thin.

Political leverage makes it brittle.

Here is where I draw the line.

It is not about whether a drug is approved or denied.

It is about whether anyone outside the scientific review committee shaped the timeline or the outcome.

That includes:

The moment review tempo or outcome is shaped by someone other than the scientists tasked with evaluating the data, the firewall is compromised.

That doesn’t always mean it’s the wrong decision or bears a catastrophic outcome. But integrity is an all or nothing proposition. Even the slightest tear in the fabric leads to eventual problems.

I feel obligated to clarify something.

We are not yet at a point where patients should panic about what’s on pharmacy shelves.

An overwhelming majority of drugs currently approved are likely safe and effective. There is no evidence of widespread dangerous approvals.

But the structural incentives are changing.

The FDA’s authority has always depended less on force and more on perception. Patients trust approval because they believe it reflects insulated scientific judgment.

The moment that perception shifts, authority weakens — even if the science hasn’t.

If trust erodes, two things happen:

We have already seen what happens when trust in institutions collapses. Disinformation fills the void.

Medicine cannot function in that environment.

Some will ask: isn’t this just how business works?

Yes.

Corporations respond to incentives. If influence works, influence will be used. That is neither shocking nor unique to this administration.

The problem is not that companies try.

The problem is when influence becomes effective.

If drug companies believe that appealing to the White House improves their odds, they will escalate. If expedited timelines can be negotiated, they will be negotiated.

This does not require bribery. It does not require overt corruption.

It only requires an opening.

And where there is opportunity, you better believe Big Pharma will capitalize.

I am not a politician. Or a lobbyist.

I am a pharmacist.

My duty — and the duty of every health professional — is to protect patients.

When I counsel someone on a newly approved medication, I rely on the assumption that it was evaluated rigorously, consistently, and without political favor.

When you take a new medication, you rely on the assumption that an independent group of experts deemed it safe and effective.

Those assumptions used to be inherent. Trust was automatic.

Now they require vigilance.

We are not in crisis.

But we are in transition.

We don’t accept executive interference with the Justice Department, and we shouldn’t accept it with the FDA either.

If we do not pay attention to how regulatory guardrails are shifting, we may wake up one day to discover that FDA approval no longer means what we thought it meant.

FDA approval used to mean “evaluated in a vacuum.”
Now it may mean “evaluated with influence.”

As a pharmacist, that distinction matters.

It should matter to you, too.

Alec Wade Ginsberg, PharmD, RPh
4th-Gen Pharmacist | Owner & COO, C.O. Bigelow
Founder, Drugstore Cowboy