The story of the United States Food and Drug Administration is a story of mismatches.
Mismatch one: cramming both food and drugs regulation into a single agency. Humans have been making food since the beginning of time — it is in fact one of our defining characteristics — and while the methods have become more and more intricate and our definition of food wider and wider to now include some decidedly unfood-like substances it is not a field where people expect too much experimentation and adding risk to production yields absolutely no reward to the end user. Drugs as used now — aspirin aside — are a modern invention. We learned about DNA less than a century ago and cell & gene therapy weren’t even an idea until late into the 20th century. An eye-blink, compared to food. And when it comes to production, risk is very much encouraged for those who need the drugs, particularly for rare diseases without approved therapies.
That is the second mismatch, one within the Drug section of the FDA: generic drugs that have been used for decades are more like food, unapproved, experimental treatments are quite the opposite. This is a source of constant tension that leaves much room for improvement. To be clear: Europe is worse. EMA requires drugs tested at any stage to be manufactured in a fully audited manufacturing facility; FDA allows for “phase-appropriate GMP compliance”. This still requires major investment, lest you leave yourself exposed to the whims of a random audit.
The third mismatch, one written up in STAT this morning, is one of management. Regulation of food and established drugs requires a certain mindset and personality type; regulation of experimental drugs is something else entirely. There is a paradox here: while most of FDA’s work is focused on the first two — it is the baseline activity absolutely essential for proper functioning of society — the focus of the public is mostly on the third. Unless, of course, something goes wrong which it amazingly rarely does considering the amounts of food consumed in this country. But the culture has been determined by this baseline activity, and I imagine people going to work at the FDA self-selected for that kind of culture: steady, stable, contemplative, detail-oriented and intentionally boring.
Which is to say, I am not at all surprised about reactions like this, where I can absolutely see both sides of the story and in fact agree with both. But the tie-breaker is this: the steady-as-she-goes leadership of what should be the leading edge of innovation has led to the US getting further and further behind China all while its taxpayers are bankrolling said innovation. This state of affairs is untenable and all the policy memos in the world won’t help unless this root mismatch is resolved.
If you figure out a way to do it — and do it with urgency — that does not involve breaking up the FDA into at least two pieces, do let me know.