Why is the FDA so weird? History!

Why is the FDA so weird? History!

This little essay is the short form of part of an educational class I run for EU and Asia company boards to help them understand why the Food and Drug Administration is a bit weird and seems arbitrary from the outside. I promise you'll learn a few things, and even get some insight into why our Class II device rules work the way they do (blame our Congress, and tradition).  

Also, I tend to snark and digression, so you have been warned.

History is a detail loaded and often quite silly in retrospect, and it can still mess you up in the present if you aren't aware of the weird twists and turns. My goal in this post is to boil down some USA history of regulation so you can feel the differences sensibly.

Let's rock!

There are major differences between FDA style regulation and the way that international standards and norms function. Remember that ISO as we know it was not inevitable. ISO (International Organization for Standardization) was founded on 23 February 1947, by a small clique of nations. It's roots run a bit further back, to the 1926 International Federation of National Standardisation Associations, which was focused on mechanical engineering for obvious reasons - screws need to work everywhere, you see, when your ships might need service anywhere. But that early organization folded sometime in the chaos leading up to the second World War.  Afterwards the United Nations had a standards committee that recommended forming an international union.

I mentioned that ISO was initially Western European nations and the USA, which participated as an uncle, secure in the superiority of American practice (ANSI, ASTM, etc.). And also, from the American point of view, when it comes to standardization, we had the first continent scale systems already, and if you accuse an American of chauvenism they just wonder what you are talking about.

So why is the FDA so different? It's been around for a long time. Even with participation by a lot of great people there in things like the Global Harmonization Task Force, and members on various ISO committees (I've served on a few) the FDA has an institutional DNA. So how long has the FDA been doing what they do?

To paraphrase Ernst Haeckel's phrase "ontogeny recapitulates phylogeny", organizations acquire layers of methodology and psychology as they are given, or lose, various statutory powers and incomes. How far back do you think the FDA's roots go, given the USA has only been around in current form since 1789?

Pardon the digression, but I rented an apartment in Paris for a couple of years in the early aughts, and the building was older than that (just barely, thank you Haussmann). And I apologize to real historians for this light treatment of the topic, I am merely an engineer and businessman.

If you don't already know this, the FDA goes back to 1820. Not under the same name, but the organization wiggled and adapted over time as needs grew.

The first US Pharmacopeia was established in 1820, with a small team to manage it. When the Congress decided that imported drugs need to be regulated and taxed, the Drug Importation Act was passed in 1848 (the UK/China Opium Wars may have been part of that discussion in the Hallowed Halls of Congress, but historians disagree).

So the first people tasked with concern for drugs were roped into this new expanded authority. It made sense that when the 1862 Bureau of Chemistry was established in the Department of Agriculture, it had a lot of institutional learning and key people to rely upon.

But there was an expanding population, territory, and a lot more health and safety concerns and the people demanded that Something Be Done, and so as these things go, something finally was, and in 1880 a National Food and Drug law was proposed on the basic principle that if you call something "milk" it should have come out of the right part of the cow (for instance). That being what we call the "Gilded Age" the proposal to infringe on the profits of monopolists didn't immediately stick.

This made a lot of people cranky, including the ones in the Bureau who wanted to make life better.

It took another generation, so when 1906 rolled around, the Food and Drug Act was passed. At last. And where to get their staff and what historical references were replied up on? The Bureau of Chemisty, where there was already a bit of a culture, especially around medicaments, going back now almost a century. Various beaurocratic and legal challenges were worked on, but the results were not completely satisfying to the public, so in 1927 (almost another generation) the Food, Drug, and Insecticide Administration was created by splitting the Bureau of Chemistry and putting all the drug and food and pesticide people into one agency.

It's important to note that this Administration was granted some actual power, including a bit of control over labeling and advertising and the purity of products as well as the right to inspect imports and file legal actions. So in just a few more years, you would know that your Heroin wasn't diluted! In slow steps we make progress.

But still, something was lacking. There was no consideration of safety. That was rectified in 1938 when the FDIA was given the power to ensure safety of products and certain important enforcement powers. And it was an improvement. In fact, it helped enough that aside from court cases and various minor legislative tweaks, all remained stable for a good while.

Regulation enforcement carried merrily along until the 1970s, when Insecticides was slid into the new Environmental Protection Agency, and the FDA that remained was given power to regulate medical devices. This was not something they had lots of experience doing, while they had 150 years of institutional muscle memory around chemicals.

There were quirks. Low risk products merely required some safety testing someday. Defining high risk was a task that took awhile, but they had the pharma clinical trial methods to leverage once they created all the many "ABC" categories and assigned them. The middle stuff, the bulk of the devices on the market, were assumed safe enough, but if you wanted to change them or do something slightly different, you had to be able to refer back to an earlier product.

This is why FDA middle risk products are 510(k) by reference to a key section of the enabling legislation. And why you, as a device developer, have to do the "predicate device" tango. On which many have written much, and many a firm has foundered. Do not step on the FDA's toes when you tango 510(k) with them.

Since then we have had the 1981 improvements in human trials rules (much needed), then the 1990 authorization for the FDA to do post-market surveilance in an attempt to cut down on all the garbage out there (ask me, I started in this industry in the late 1980's and it was wild, surgeons would make a thing in their garage after their third cocktail, then use it in surgery the next day and I have seen that with my own eyes).

1993 was also some needed expansion of power with "MedWatch" complaint reporting, which is almost but not quite even now like the ISO 13485 system, and a main place for foreign companies to trip up. And then, bringing us almost to the modern era, 1997 was a good year for privatization and neoliberal economics, and also for restructuring under the FDAMA rules, which really was designed mostly to make the agency self-funding through company fees, because nobody has ever heard of regulatory capture or perverse economic incentives.

Since then we've had some minor tweaks, and the addition of some much needed oversight of cosmetics and personal care products this year (MoCRA, see my "Don't Panic" blog post). When I say much needed, and that I think the FDA approach is pretty sensible, I do not make friends. The problem is that ecommerce has flooded the USA with garbage promoted by morons on social media companies that conveniently have a storefront for brands. If you thought Alibaba and Amazon were full of dangerous stuff, you should see the TikTok marketplace (not China bashing here, they just saw what the USA companies were doing and did more of that - better and faster).

In conclusion:

First: The reason the FDA seems inscrutable is that it now has two centuries of accumulated DNA. And also, they kept thalidomide out of the country, which was absolutely the right thing to do back then. They will remind you of this if you get snarky. Hell, they delayed LASIK in the USA until it was almost kinda mostly good, and I worked on those early systems and agree with them.

Secondly: the "Class II" rules are based on lots of historical law and legal enforcement; the agency isn't trying to be difficult (much), they are following an increasingly obsolete section 510(k) rule set that frustrates them almost as it does medical device companies.

Thirdly: I don't think your ISO auditors can make a phone call and have people in uniforms with firearms shut you down. The FDA can do that, and they can seize all of your incoming products and charge you for the privilege. I've worked w/ companies that have been locked down, or had all their containers sitting out in the sun, impounded. Please don't think the FDA is like your local ISO/CE and ministry folks - the FDA is all in one place, and they only have a sense of humor if you show respect, solid data, and don't have a pile of warning letters.