The FDA Needs More Funding Now to Enable Future Technologies

By Sasha Stafford | Principal Scientist & Founder | Elixis Biosciences & Prodelic Technologies 

There is a pervasive narrative in the biotechnology and pharmaceutical sectors that the U.S. Food and Drug Administration (FDA) is an adversary—an obstacle course of red tape designed to slow down innovation. But this framing misses the fundamental truth of what the FDA actually does. The FDA is on the side of drug developers, and more importantly, it is on the side of the public.

Scientists Protecting the Public

The personnel evaluating new INDs (Investigational New Drugs) and NDAs (New Drug Applications) are not simply bureaucrats; they are scientists, physicians, and engineers. Their mandate is not to block progress, but to protect the American public from fraud, snake oil, and unsafe practices.

When a company brings forward a novel technology—whether it's an advanced lipid nanoparticle delivery system, a complex biologic, or a new hydrogel platform—the FDA must rigorously evaluate claims that have never been tested on humans at scale. The skepticism they apply is the exact same scientific rigor that we, as researchers, apply to our own bench data. They ask the hard questions because the consequences of getting it wrong are measured in human lives.

To understand the weight of this responsibility, we only need to look at one of the defining moments in regulatory history: the thalidomide crisis. In the early 1960s, a new FDA medical officer named Dr. Frances Kelsey was assigned to review an application for Kevadon (thalidomide), a sedative heavily marketed in Europe as a safe treatment for morning sickness in pregnant women. Despite immense corporate pressure and repeated complaints from the manufacturer that she was being unnecessarily bureaucratic, Dr. Kelsey refused to approve the drug, insisting the safety data was insufficient. Her stubborn reliance on scientific rigor prevented the US from experiencing the tragedy that swept across Europe, where over 10,000 children were born with severe limb deformities. Dr. Kelsey's legacy is a stark reminder that regulatory friction is often the exact mechanism that protects public health.

Quality by Design: Demonstrating Process Control and cGMP

Beyond the clinical safety and efficacy of the active pharmaceutical ingredient itself, the FDA places a massive emphasis on how a product is made. Regulatory reviewers are looking for manufacturers to demonstrate absolute control and deep, mechanistic knowledge of their formulations and manufacturing processes.

This is not arbitrary box-checking; it is the foundation of patient safety. When the FDA audits a quality system or scrutinizes a Chemistry, Manufacturing, and Controls (CMC) submission, they are verifying that a company understands its critical process parameters and can consistently produce a safe product at commercial scale. Whether a sponsor is developing a complex nanocarrier or scaling up an established delivery architecture, they must prove that quality is built into the design, not just tested into the final batch.

This expectation of absolute control is also why the FDA enforces current Good Manufacturing Practices (cGMP). That "c" is critically important. The standards for manufacturing, analytical testing, and quality assurance are not static—regulations and industry guidance are ever-evolving as technology, analytics, and scientific understanding advance. What was considered a robust quality process a decade ago may no longer meet today’s rigorous standards. The FDA expects developers to actively monitor these shifting guidelines, continuously modernize their quality systems, and embrace lifecycle management. By viewing the FDA's evolving CMC expectations as a shared commitment to robust manufacturing excellence, developers can align their own internal operations with the agency's ultimate goal: delivering reliable, uncompromised therapies to the public.

The Future of Complex Therapies and the Innovation Gap

The challenge the FDA faces today is not a lack of interest in innovation, but a massive disparity in resources. As our understanding of human biology, immunology, and genomics deepens, the therapies we develop are inherently becoming more intricate. We are rapidly moving away from an era dominated by simple small molecules. Looking forward, highly complex drug products and combination therapies—which seamlessly merge active pharmaceutical ingredients, biologics, and advanced device components like smart nanocarriers, drug-eluting implants, or sensor-enabled delivery architectures—will become the industry norm rather than the exception.

The private sector pours billions of dollars into this rapid technological advancement. These novel modalities are evolving faster than the regulatory frameworks designed to assess them. The FDA often requires education on these cutting-edge technologies, but this isn't a failure of the agency; it's a symptom of underfunding and understaffing in the face of exponential scientific growth. If we want faster approval pathways for these groundbreaking, multi-modal therapies, the solution is not to bypass the FDA, but to adequately fund it.

• Greater Manpower: The FDA needs more specialized scientists to evaluate complex combination therapies without backlogging the system.

• Modernized Infrastructure: Regulatory science needs the same technological and data-processing upgrades that private-sector R&D labs utilize.

• Proactive Education: Increased funding would allow the FDA to proactively research emerging technologies, rather than reacting to them only when a highly complex application lands on a reviewer's desk.

A Collaborative Future

The FDA is deeply interested in the science we are developing. They want safe, effective therapies to reach patients just as much as developers do. By viewing the agency as a collaborative partner in public health, rather than a hurdle, we can foster a more efficient ecosystem.

Advocating for a stronger, better-funded FDA is advocating for a safer, more robust biotechnology industry.

What does this collaborative ecosystem look like in practice? The FDA Drug Review & Oversight Loop below illustrates the continuous exchange of data and feedback between developers and regulators. Rather than a linear obstacle course, the pathway from pre-clinical R&D to post-market surveillance is a shared loop, designed to ensure that rapid innovation is matched by uncompromising scientific validation at every stage.