FDA Now A Supply-Chain Complication

By Louis Garguilo, Chief Editor, Outsourced Pharma

Globalization nor its opposite, reshoring, are the stabilizing operating frameworks they once seemed to be.

COVID. The BIOSECURE Act. Trump’s tariff tantrums. China chicanery challenges. Europe’s repositioning and war. South Korea’s rise. India’s widening role.

However, through any macro- or intra-industry variance, reliable regulatory guidance should steady the ship. 

Unfortunately, many believe we are crossing the Rubicon to regulatory-leadership discontinuity, and suffering a disunity at the FDA impacting our supply chains.

With the resignation of FDA Commissioner Marty Makary and the departure of other FDA officials, we need to address this question:

How is the FDA impacting development and manufacturing outsourcing?

Outsourcing And Regulatory Stability

We know this by heart: Drug innovators outsource to economically gain flexibility and access capabilities and capacities. Outsourcing serves as development stability.

If a biotech’s shot on goal does not pan out pre-clinic or in trials, the repercussions are mitigated by contracting with CROs and CDMOs.

On the other hand, a successful program crying out for additional human resources, bigger facilities, or different equipment is answered by external partners.

In all cases, though, supply-chain partners rely on regulatory predictability as they aim at precise development and manufacturing execution.

Timelines, scale-ups, desired product profiles and quality aspects are dependent on CMC fundamentals, in the U.S. laid down by the FDA. Manufacturing investments also depend on accurate readings of regulations.

Tech-transfer schedules, comparability plans, process validation strategies, and commercial-scale expansions advance with educated assumptions regarding how regulators will interpret scientific data, quality systems, and manufacturing controls.

We’ve seemingly been moving to an environment where those supply-chain assumptions have become less reliable, and the consequences have moved beyond regulatory affairs.

Responding To FDA Strife

Before moving on, let’s point out not all is negative at the FDA.

For example, in a very nice post on LinkedIn by Greta Brunet, she points out that some “45% of the time between when a company conducts a Phase 1 clinical trial and submits its final application to the FDA is what the agency now calls “dead time” - paperwork, administrative tasks, and sequential hand-offs that add no scientific value and delay every decision that follows (FDA, 2026).”

“On April 28, 2026, the FDA declared that model officially obsolete,” writes Brunet. She says the announced was “fundamentally undersold”; it is not an incremental AI upgrade to an existing process. “It is a structural rewiring of how the U.S. government oversees clinical drug development.”

So there are positives at the agency. But if instability creeps into the regulatory-agency level, sponsors may respond in several ways.

They might select their CDMOs differently, putting the greatest weight on CDMOs with deep regulatory and FDA experience.

CDMOs may not have experienced anything quite like the current atmospherics, but many have zagged through multiple FDA administrations, enforcement eras, and philosophical swings regarding compliance expectations.

External partners can employ former FDA personnel and maintain larger regulatory teams. Collective experience builds internal intuition; CDMOs can draw on decades of interactions with inspectors and reviewers.

In calmer periods, sponsors focus on factors such as speed and cost competitiveness. During uncertain periods? Regulatory guidance and track record rise in value.

A sponsor asks, “Can this CDMO manufacture my product and effectively assist us in navigating a more volatile regulatory environment?” The current unease could have sponsors hesitating to place critical programs into less-tested CDMOs.

Optionality associated with outsourcing could diminish with, for example, sponsors feeling pushed toward consolidated, Big CDMO partners.

Last year I suggested customer service is now a premier differentiator among CDMOs. Acute agency awareness is today a part of customer service – the ability to provide up-to-the-moment readings of regulatory directionality.

Another sponsor response to regulatory shifting is (again) thoughts of  diversifying geographic exposure. Already the imposition of tariffs and trade tensions inserted supply chains under microscopes.

Are we adding regulatory unpredictability – in the U.S.! –  to our geographic scrutinizing?

The U.S. Still The One

I do not want to overstate the situation at the FDA. None of this thought bubble suggests the U.S. market will not remain central to global biopharma economics.

However, the more uncertainty surrounding any national or regional regulatory environment, the more repercussions spread throughout the drug-development cycle.

Are globally experienced outsourcing partners now regulatory shock absorbers on a bumpy road to commercialization?  

I’m not sure what that looks like.

It suggests what has always been required of our partners: experienced personnel, solid quality systems, reliable facility and equipment maintenance, documentation practices, inspection readiness, flexibility.

There's a new concern, though.

Innovators may over-prepare submissions, unnecessarily extend development timelines, add more consultants, conduct additional studies and run more batches (and pay for them), as well as (unnecessarily) alter their selection of CDMO and production geography.

None of that is good for the efficiency of our outsourcing system. 

Stability at the FDA is itself part of our healthcare infrastructure. The agency is foundational to the functioning of the biopharma economy.

At times the FDA will and should change leadership and evolve policy. Each administration brings priorities.

In July of last year I wrote an editorial titled, The FDA Was Darned Near Perfect, Right? It threw  shade at those who had been advocating for change at the agency … until it came. I stand by the assessment that too much vitriol thrown at the FDA is to political bias.

But we’ve now experienced a cumulative effect of FDA inconsistencies judged as such across the political spectrum. Some sponsors are changing how they plan clinical trials and build regulatory strategy.

The Association of Clinical Research Organizations (ACRO) notes that frequent FDA leadership changes and staff turnover have increased anxiety and unpredictability in interactions with the agency.

That suggests all of us should take a deep breath. Vigilance and concern are always part of the drug industry.  

When sponsors begin altering outsourcing relationships and clinical-trial strategies because of uncertainty at the FDA, more supply-chain challenges are created than corrected for.