The Alliance Believes in FDA Exceptionalism, You Should Too.

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. The Alliance believes 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 and vital, but only has about five central responsibilities. Its thousands of employees repeat each function 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 search the SSA website and produce a couple of additional functions, but the list would not grow much.

In contrast FDA has many more responsibilities than other federal agencies. Each is different from another. 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, working with states on food safety 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. The availability of adequate resources is vital to the agency’s  essential activities.

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.

A timely and quite different example is FDA’s announcement this week that mifepristone, one of the drugs used in medication abortion, can be dispensed in brick-and-mortar pharmacies. Whatever your view of the merits of this change, it will predictably draw the agency into one of the most socially divisive issues in the United States.

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 complex responsibilities that are continually expanding.

Growing responsibilities require a budget that grows. Even compared to other high-growthy agencies, FDA is exceptional and needs resources substantially greater than what it is receiving today.