Recent discussions about FDA departmental changes and budget cuts have raised concerns across the life sciences industry and among American consumers. As the agency responsible for ensuring drug safety, preventing counterfeit products, and maintaining market integrity, any reduction in FDA oversight could have far-reaching consequences, not just for industry stakeholders but for patients who rely on the safety and efficacy of their medications.

At the International GMP Conference held in early March 2025 at the University of Georgia in Athens, industry consultant and former FDA Compliance Officer Marie Mathews addressed these concerns, highlighting the FDA’s importance and the potential impact of cuts to its budget and regulatory activities. She discussed how the FDA serves as a “moat”—a crucial barrier that protects both the pharmaceutical industry and consumers from substandard or counterfeit drugs. A weakened FDA, she warned, could lead to an increase in unregulated players attempting to fill the void, putting patient safety at risk.

The Importance of Transparency for American Consumers

The integrity of the life sciences supply chain hinges on the FDA’s ability to rigorously inspect manufacturing practices, enforce quality standards, and police unapproved drugs. Without this oversight, both consumer trust and industry confidence in regulatory standards would erode, making it harder for companies to compete fairly and for patients to rely on their medications.

Mathews shared a striking example of a medical provider in Connecticut who, due to opioid addiction, substituted pain medications with ineffective alternatives. Patients undergoing painful procedures unknowingly received subpotent drugs, yet none of them reported the issue to the FDA—highlighting how difficult it is for consumers to identify quality failures without regulatory intervention.

This example emphasizes why regulatory transparency is not just an industry concern—it is a fundamental patient safety issue. Freedom of Information Act (FOIA) requests, inspection reports, and enforcement transparency allow companies and consumers alike to make informed decisions about drug quality. The FDA’s ability to conduct these activities is essential to maintaining trust in the life sciences industry.

Mathews’ key points: Why the FDAs Role Matters

FDA oversight ensures patient safety and industry integrity. Without strong oversight, counterfeit and substandard drugs could infiltrate the market, harming consumers and eroding trust in medications. This protection benefits both businesses and patients by ensuring only safe, effective drugs are available.
Lack of FDA oversight would lead to an increase in unapproved and counterfeit drugs. Consumers would be exposed to greater risks, with little recourse to identify unsafe products.
Investigating and policing unapproved drugs is a significant part of FDA’s work. Mathews estimated that 35% of her time as a compliance officer was spent tackling these issues. Weakening this function would allow unsafe drugs to persist in the market, putting patient health in jeopardy.
Budget cuts and resource reductions weaken FDA enforcement. The loss of resources, such as the Atlanta Investigations office, could lead to inconsistent oversight and enforcement gaps that put consumers at risk.
Regulatory oversight benefits everyone and builds trust. When the FDA has the resources it needs to conduct thorough inspections and enforce regulations, consumers can have greater confidence in the safety and effectiveness of their medications, the life sciences industry will have a regulatory partner to help ensure drug quality.

Protecting Your Business in a Changing Regulatory Landscape

In the pharmaceutical industry, regulatory oversight isn’t just a requirement—it’s a safeguard against risks that could impact patients and businesses.

As FDA resources fluctuate and regulations evolve, industry will need a proactive approach to compliance. The Redica Platform delivers real-time insights into enforcement actions, supplier quality trends, and regulatory risks—helping businesses stay ahead.

By leveraging Redica’s insights, companies can:

Monitor regulatory changes and anticipate enforcement actions.
Identify and mitigate risks before they escalate.
Ensure their suppliers and manufacturing partners maintain high-quality standards.

Regulatory uncertainty isn’t going away—proactive compliance is the key to staying ahead. See how the Redica Platform can help—schedule your demo today!

In Her Own Words: Marie Mathews on FDA’s Role

The following is a transcript of the section of Marie Mathews’ presentation that inspired this article. In it, she draws on her experience at the FDA and in private practice to highlight the value the FDA provides to U.S. patients and the risks of weakening its oversight

This is the ‘Why would you care that FDA is getting cut?’ portion of my talk.

Apart from the fact you might take FDA regulated drugs or eat FDA regulated food, FDA provides certain services and protections to our industry and we don’t always think about. FDA provides the American drug industry with a moat. And it’s a big moat.

I don’t know if any of you remember in New York, the taxi drivers had medallions and they went as high as a million dollars to get that right to drive a taxi in New York. When Uber came in, they lost their moat. Not only that, their clients can tell the difference in quality. So you can tell if your cab driver is a bad driver or his vehicle stinks. No offense to anyone. I’m just saying you can appreciate the difference between one cab and another. For pharmaceuticals, we can’t do that. Most of us have probably had an experience with feeling like a drug didn’t work. But how many of us knew it was actually subpotent?

Here is another example. There was a medical provider in Connecticut that was addicted to opiates and switching out all the pain relief for patients that were having a painful procedure. Not one person reported that to the FDA as being subpotent. Instead , all of those women were told that they just didn’t react properly to the correct amount of the drug. So this is not pejorative about anybody. This is simply saying we do not look at drug efficacy even as, I mean the patients do maybe, but not medical providers.

So this is a big deal. FDA is the moat that is protecting everyone’s applications. I was a compliance officer in the field and with CDER. And when I cannot tell you how many calls I got because somebody was selling a product competing with yours and they shouldn’t be.

FDA is the one that is going out and protecting your applications. And you also call me if there’s a compounding pharmacy or an outsourcer out there who’s getting a really bad quality API imported from overseas that isn’t properly inspected and is then compounding a competing product with all of ours. This has a significant fungible monetary value if there’s no one out there protecting our FDA approved applications.

Figure 1 | Regulatory Strategy Challenges and Potential Secondary Impacts

And the other way we know that is by checking the stock market. When a drug company, especially a small one, is about to get FDA approval, the stock price skyrockets and if they don’t get it, it goes down. It has monetary value, but it’s only going to be valuable if there is someone out there, if FDA can send an investigator to go knock on their door and say, “I’m here. I got a call that you might be distributing unapproved drugs.” We don’t say it like that, but that’s what we do.

I would say 35% of my work was dealing with unapproved drugs on the American market. And I had a sterile expertise. So it just shows you that wasn’t even my bread and butter. I tended to do more sterile work, but I did a lot of policing.

The marketplace counterfeits are another big deal. FDA is the only reason why Walter White of Breaking Bad is not your competitor. He was a good chemist.

FOIA is another example. We need that for our quality programs. That’s how we know if our API suppliers or manufacturing partners are out of control.

I’m not going to have time to get through all of this, but my belief is if FDA does decrease activity, we will see the rise of other stakeholders in the drug quality realm. We’ve already seen some action from state regulators. Obviously, we might be moving to contractors.

The Atlanta Investigations office has lost its lease. It has not been reinstated that I know of. It’s based in College Park. None of the records online are accurate*. It’s listed only as the imports branch for Atlanta, but it’s actually housing all the drug investigators as well. That was announced yesterday as being cut by DOGE. Those import investigators and inspectors are part of who’s protecting our moat from counterfeit products and from bad actors.

End of Transcript.

*Estimate based on work as a domestic field compliance officer.
**The FDA Inspector’s Operation Manual lists FDA Atlanta Location as 60 Eighth St., which and lists the College Park location under the “Georgia Import Office and Ports of Entry”.