The FDA Was Darned Near Perfect, Right?
By Louis Garguilo, Chief Editor, Outsourced Pharma
I return you to five minutes before Donald Trump officially became president on January 20th, and to a time when the FDA was near perfect.
That’s what one would assume today listening to the many of us up in arms over the agency.
Of course, the reality was quite different. We seem to have erased the memory that segments of our biopharma industry – and patient advocates – were ardently articulating the need for serious adjustments at the FDA.
Since the start of 2025, any adjustment implemented (or suggested) at the agency by the new (adjustment-focused) administration is verboten. The changes will end the biopharma industry as we know it.
Please.
To help us regain perspective, we’ll go over some reminders of what we really thought of the FDA, and why our current fanaticism is uncalled for (example headline from The New York Times: “Inside the Collapse of the FDA: How the new health secretary, Robert F. Kennedy Jr., is dismantling the agency.”)
Readers may be asking, ‘How does this relate to our focus on drug development and manufacturing outsourcing and working with CDMOs?’
Let’s start there.
What’s Your CDMO To Do?
The FDA is shifting, we can agree on that.
You and your CDMO can use this opportunity to mature into better policy implementation partners should adjustments to your development and products, and regulatory approach, be necessitated.
As we know, the role of the modern CDMO isn’t simply to execute against regulatory checklists, so to speak. It’s to help put policy into practice – across hundreds of client programs.
But if we in the outsourcing sector meet every FDA policy or suggestion – no matter what it is – with a predetermined opposition because it comes from an administration we didn’t expect – we trade credibility for personal comfort, and outcomes for outrage.
Generally (and yes, the devil is in the details, as they say), what are the changes we are talking about?
Some target increasing transparency in development and manufacturing, quality reviews, or even revisiting approval pathways and products. These must be weighed carefully.
Who better to do that, and gather more self-introspection in the process, than those professionals responsible for developing and making so many of our drugs?
CDMOs are our nexus between biotech ambition and FDA expectations – whatever those expectations.
Our partners’ practical insights can also help us shape policy in ways both pro-innovation and pro-compliance—if we offer the new FDA team more than vitriol.
Grievances Revisited
The FDA, for all practical purposes, is the world’s leading regulatory body.
Nothing here diminishes that outsized role (or the roles of the CMC, or HHS overall). The U.S. has created, and thankfully lives in accordance with, a governmental oversight that helps ensure for patients that our products are safe and effective.
That’s why a level-headed discussion of what the FDA is up to is warranted and healthy. For example, here are three points of emphasis we had about the FDA pre-2025, and remain today.
1. A too lengthy and often delayed review process
We have often protested that the FDA’s drug (and medical device) review process was way too slow. In fact, we’ve complained vehemently about bureaucratic inefficiencies, cumbersome and confused administrative procedures.
The FDA deserves much credit here for attempts to remedy this with various fast track and other expedited pathways to commercialization. But few disagree improvements can still be implemented.
2. Revolving doors and industry influence
We registered concerns that former industry executives or consultants too often find their way to positions within the FDA, and very much vice versa, leading to potential conflicts of interest.
Critics argued the cozy relationships between FDA officials and the pharmaceutical or medical device industries lead to regulations or guidelines overly benefiting certain stakeholders. At the least, there can be an appearance of bias eroding public trust.
3. A crises of public trust
We should have come out of the COVID years as unassailable heroes. And so many individuals were in fact heroes through that terrible time.
But the systematic shutting down of our economies and schools – our lives – and any debate surrounding the COVID vaccines has been in retrospect quite damaging.
“Follow the science” was used as a truncheon. That phrase is now a pejorative among a majority of Americans.
All told, communication issues, questions of procedural delays and perceptions of conflicts of interest have contributed to a decline in public trust.
Attacking the new administration in the manner too many of us have helps address none of this.
The Supply Chain Lubricant
Outsourcing ecosystems put regulatory policy into practice. We all crave an optimally efficient and effectively run FDA (CMS, and overall HHS) to guide us to the creation of the best materials and products.
As we end this look back and reemerge with this new administration, recognize the need for previous improvements has not dissipated, and now we have changes coming.
I advocate for nor criticize any of those in this present exercise. Certainly, in the months (and years) ahead, there will be much to raise voices over, and perhaps try to dissuade or influence.
But let that process play out. Civilly.
Let’s resist jumping up and down in protest at new leadership, and stop pretending the former leaders heading our agencies were saintly.
Look critically but unjaded at today’s attempts to meet some of the challenges mentioned above. Let’s remember where we started.
And where we started was thinking we needed change. Will it be change for the better?
Like development and manufacturing outsourcing, performative resistance certainly won’t lead to improved performance. We valuate evidence; we do not drive emotion.
Professional engagement with all partners, including today’s FDA, will work best. Successful drug sponsors know that. We can use those lessons of engagement as we challenge the new FDA.