FDA User Fees Under Fire

Today, we’re tackling a question that maybe sounds straightforward, but could have complicated, unforeseen consequences. That question? What happens if the FDA stops collecting user fees from drug companies? At first glance, it sounds like a win. Less corporate influence, more independence for regulators. But is it really that simple? 

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• The Cost of Free: What Removing FDA User Fees Could Mean for Drug Innovation and Public Health

About the author

• Matt Quinn, Ph.D.
  
  

Transcript

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Host 1: 

Hello and welcome to another episode of Womble Perspectives. Today, we’re tackling a question that maybe sounds straightforward, but could have complicated, unforeseen consequences. That question? What happens if the FDA stops collecting user fees from drug companies? At first glance, it sounds like a win. Less corporate influence, more independence for regulators. But is it really that simple? Today, we’re unpacking the Make America Healthy Again Commission’s proposal to eliminate FDA user fees and what that could mean for drug innovation and public health. 

Host 2: 

Yeah, when you first hear about this, it might sound like a great idea. But digging deeper into what those fees actually do, it’s a lot more complicated than it seems. 

Host 1: 

Let’s start with the basics. User fees came in with the Prescription Drug User Fee Act in 1992. The idea was to let the FDA collect fees from drug companies to help fund the review process. 

And now, those fees aren’t just pocket change. They cover more than 60% of the FDA’s drug review budget. That money pays for specialized reviewers, faster evaluations, and even pre-submission meetings companies rely on. 

So, in short, user fees keep the wheels turning. Without them, the FDA would be… well, pretty underfunded. 

Host 2: 

So why remove them? MAHA’s argument is about independence. They say user fees create conflicts of interest, like the FDA being too cozy with industry. They point to revolving doors and potential bias. 

All fair concerns. But here’s the kicker: the report doesn’t offer a clear alternative funding model. So if we pull the fees, where does the money come from?  

If user fees vanish without a backup plan, the FDA loses billions. That means fewer reviewers, slower approvals, and a potential bottleneck for innovation. 

Host 1: 

And smaller biotech firms would really feel it. They depend on FDA guidance to design trials and avoid costly mistakes. If those pre-Investigational New Drug meetings disappear, it’s like flying blind. 

Plus, think globally. The U.S. leads in drug development partly because of efficient regulation. Slow that down, and investment could shift overseas. 

Which leads to the question: is the argument flawed? Well, here’s what gets overlooked: most early-stage research happens in federally funded academic labs. Industry builds on that, and user fees help sustain the infrastructure to evaluate new therapies. 

Host 2: 

So instead of a conflict of interest, it’s more like shared responsibility. The FDA needs resources to keep up with complex science. Cutting fees without a plan could be a risk. 

Host 1: 

So, where does this leave us? Well, if we’re pursuing a goal of independence, one possible answer could be strengthening transparency, oversight, and scientific rigor. 

Removing user fees without a viable alternative could weaken the very agency that protects public health.  

Thanks for listening to Womble Perspectives. If you enjoyed this conversation, share it and subscribe for more insights at the intersection of science, law, and policy. 

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