Dr. Heidi Overton And The FDA: An Outsourcing Perspective

By Louis Garguilo, Chief Editor, Outsourced Pharma

There’s something sadly predictable about negative media reaction to a woman whose professional accomplishments ought to command attention before criticism:

• M.D. from the University of New Mexico School of Medicine
• Trained in general surgery at Johns Hopkins, where she completed a surgical-oncology research fellowship; during her surgical residency, she reportedly performed hundreds of surgical cases
• Ph.D. in Clinical Investigation from the Johns Hopkins Bloomberg School of Public Health
• Board-certified in Public Health and General Preventive Medicine; a physician advocate for healthcare price and quality transparency

The initial condescension to Dr. Heidi Overton’s nomination to head the FDA downplays the above to focus on these (what considered objectively are also admirable) accomplishments:

• White House Fellows program for two years
• Office of American Innovation, and the Domestic Policy Council, advising on healthcare policy and working with Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid Services (CMS) Senior figure at the America First Policy Institute (AFPI)
• Deputy Assistant to the President/Deputy Director for Domestic Policy
• Worked with the HHS Secretary on:
  • addressing ultra-processed foods
  • food and nutrition policies and dietary guidelines
  • drug-pricing initiatives; healthcare price transparency
  • childhood-vaccine policy and chronic disease
  • FDA/HHS initiatives to accelerate drug development and approvals

Too many in our media (and industry) have put their preferences in front of a fair reporting on an accomplished professional who has devoted her life to helping patients, improving healthcare as a physician and policy executive.

Overton certainly has views that bleed into the political arena. She has positions on vaccines, abortion, and other subjects. Obviously, so do the “honest brokers” in the media, and unfortunately those opinions cast shadows over both lists of accomplishments above.

In fact, when you look over a lot of the reporting, there's been little focus on the FDA per se.

But this is what should be of the most interest to us as we head into the Dr. Overton nomination process:

Can this accomplished professional effectively lead an FDA to help our professionals who get medicines developed, manufactured, approved, and supplied to patients?

To answer that, first we need to ask what kind of FDA our outsourcing ecosystem needs. 

Three Areas Of FDA Focus

I’ll suggest three areas to bolster drug development and manufacturing outsourcing (and the drug industry overall).

1. Predictability

There’s been a certain, shall we say, unpredictability at the FDA, mostly regarding final commercial approvals. This has only added to our understanding that among so much else, an FDA with consistent guidance benefits the entire business of outsourcing from start to that commercial determination.  

For an emerging biotech, regulatory inconsistency drains time and money (see below). It delays a start-up’s early decisions. Later on, a cancelled manufacturing slot affects both sponsor and CDMO.

Overton has concentrated on drug pricing (and healthcare costs). We’d need her to deepen consideration of the costs of inconsistency to our outsourcing milieu, and the insustainability of biotechs themselves in a shaky regulatory environment.

2. Understanding Manufacturing

Perhaps not Overton’s strength here. We need an FDA that understands today's drugs and therapies depend upon advanced manufacturing. This requires specialized analytical methods, equipment upgrades and, for example, “platform technologies.”

CDMOs have done an admirable job keeping pace with the changing requirements of their customers, diligently pursuing technologies and strategies to figure out how these products can be produced at all, and then reliably and safely.

The FDA should be of assistance. In fact, the agency has been an early proponent of continuous manufacturing; its recent movement toward greater CMC flexibility for CGT is encouraging. The agency says its approach is intended to provide optionality (while meeting regulatory requirements), and specifically notes a purpose is to help expedite product development.

Although not in her background specifically, there’s no reason to assume Overton would reverse this directionality, but we should learn about her thoughts on the entire development and manufacturing ecosystem.

3. Our Economics

This third area seems more in Overton’s wheelhouse. Frankly, the benefits of successful outsourcing on the economics of healthcare (not only specific drug pricing) should be further emphasized at the FDA.

The FDA does not determine drug prices; approval decisions are based on statutory standards for safety and effectiveness – not whether a drug is economically attractive.

But the agency influences the economics of healthcare by affecting, for example, how quickly competitors, generics, biosimilars and innovative products reach the market. Or on the other hand, protecting patent rights of first innovators.

The recent FDA initiatives exploring accelerated review and approval pathways as incentives for companies addressing national priorities are impactful.

FDA Commissioner Overton, if confirmed, should lead an agency with a visceral understanding of the devastation to a biotech that runs out of outsourcing funds because of regulatory changes, uncertainty, or miscommunications.

Consequences extend throughout supply chains. There's an economics of CDMOs maintaining capacity and allocating personnel, sourcing and purchasing sufficient quantities of materials, and on and on.

Safety and efficacy first, yes. But Dr. Overton has focused on pricing, too. We should discover whether she'll lead an FDA with a clear understanding of how outsourced manufacturing reverberates economically through the entire drug supply chain and healthcare system. 

Passing Judgement

Before Dr. Overton ever gets to a vote, she’ll face an initial Senate committee's scrutiny and a confirmation hearing (with the first to take place as this editorial is published).

In the meantime, don't buy into gratuitous denigration because she doesn’t share all of your positions. Don’t look away from her qualifications and career, or “disqualify” her devotion to public service because it was during a political administration you oppose. 

The question is whether Overton can help create an FDA more predictable, and for us specifically, one that understands the process and economics to move drugs forward at our CDMOs.

Will she distinguish regulatory rigor from regulatory-induced inertia? Frankly, nothing in her background suggests she won’t.

The world outside ours focuses intently on the FDA’s final approvals or disapprovals of new drugs. But the agency touches all we focus on at this publication.

• The biotech professionals trying to propel a molecule into the clinic by working with a CDMO
• The Big Pharma deciding to build billion-dollar facilities in the U.S.
• CMC teams trying to solve manufacturing challenges
• CDMOs holding manufacturing capacity for a client’s uncertain scale up

Let’s have serious discussions about FDA leadership. That’s what this upcoming confirmation process is for. Give Heidi Overton a fair hearing, and if confirmed, let’s work with the FDA we get.

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Also see:
The FDA Was Darned Near Perfect, Right?