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“FDA Exceptionalism,” Redux (Again)

February 19, 2021

In a town full of special interests, it takes a certain moxie to claim that your interest represents needs that are uniquely important. I am going to do it, anyway. I believe in FDA exceptionalism and you should too.

The case for exceptionalism is based on at least two propositions:

  • No federal agency has a broader range of responsibilities than the FDA, and
  • No federal agency’s mission and responsibilities are more affected by changes in science, technology, innovation, and social trends than the FDA.

Range of Responsibilities. The number of functions an agency performs is not driven by the size of its agency budget or the number of its staff. For example, the Social Security Administration is enormous, but only has five functions that its thousands of employees repeat millions of times. They verify eligibility (for SS or disability), adjudicate claims, cut and deliver checks to homes or bank accounts, update addresses, record deaths, and manage the paperwork associated with the trust funds. I am sure I could scour the SSA website and come up with a couple of more functions, but the list won’t grow much longer.

In contrast FDA has many more responsibilities — each different from another — than other agencies. At any given moment, FDA staff are reviewing a medical product for marketing approval, inspecting a farm, drafting a guidance on Bayesian statistics, evaluating a diagnostic, writing regulations for the OTC monograph process, developing strategies to combat antibiotic resistance, and so on. I could take a couple of hours continuing this list and still not exhaust the number of different functions for which the agency is responsible.

Impact of Changes in Science, Technology, Innovation, and Social Trends. FDA will have to change “what it does” and “how it does it” more in the next 5 years than most federal agencies have changed in the last 30 years. In science, consider the impact of cell and gene therapies and the rapid advancement of new therapeutic approaches, such as immunotherapies. In technology, consider the impact of artificial intelligence and complex product tracking using blockchain. In innovation, consider the impact of FDA’s New Era of Smarter Food Safety initiative and personalized medicine.

Larger societal trends also impact FDA and drive changes at the agency. As an example, the pandemic (through the medium of telehealth) is driving the decentralization of medical care (and clinical trials) from doctor’s offices and clinics into people’s homes. That change is highly dependent on digital health tools — hardware and software — that FDA regulates.

When the US started importing more medical products and food, FDA expanded its mission to make itself into a regulator with global reach. That trend is now likely to be reversed, at least in part, by a new drive to bring manufacturing back to the United States. The “on-shoring” movement is as much about medical products as it is about 5G telecommunications and computer processors. Fortunately, FDA got a head start when Congress included monies for advanced manufacturing initiatives in the agency’s FY 19 appropriation.

So, when you next hear someone say, FDA has gotten a lot of new funding over the last dozen years, please answer, True, but FDA is exceptional, with a unique set of responsibilities that continually expand.

Simply put, growing responsibilities require a budget that grows.

Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.

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